Effect of CKC and WS Exercises on PS in Unilateral Post Mastectomy Lymphedema
Sixty patients who have unilateral post mastectomy lymphedema will participate in this study. Their ages will range from 40 to 60 years. The patients will be subdivided randomly into four equal groups. 1.1.a- Group A (n= 15) (CKC group): This group will include 15 patients who will receive closed kinetic chain exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises). The total exercise time will be 30 minutes, three times per week for eight weeks. 1.1.b- Group B (n= 15) (WS group): This group will include 15 patients who will receive weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 30 minutes, three times per week for eight weeks. 1.1.c- Group C (n= 15) (Combined group): This group will include 15 patients who will receive closed kinetic chain and Weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 60 minutes; 30 minutes of CKC and 30 minutes of WS exercise three times per week for eight weeks. 1.1.d- Group D (n= 15) (control group): This group will include 15 patients who will receive complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises).
Phase
N/ASpan
57 weeksSponsor
Cairo UniversityCairo
Recruiting
Reflexo Therapy for Gestational Diabetes Mellitus
Gestational diabetes mellitus is considered a hazard factor for antenatal complications for both mother and fetus. It is characterized by glucose intolerance of variable degrees with the beginning or first recognition of pregnancy. It affects 14% of pregnancies worldwide, and it undergoes continuous changes in the diagnostic criteria, ethnicity and the population studied. There is an increasing prevalence of diabetes mellitus, and its major metabolic disorder caused by the insulin secretion defect or insulin action defect resulting from a defect in insulin secretion, insulin action, or both. As a result, it will lead to chronic hyperglycemia associated with carbohydrates, protein, and fat disturbance. In spite of the fact that the reason for gestational diabetes mellitus is still not fully understood, it is proposed that human placental lactogen has growth hormone-like actions, and that it causes lipolysis and thus increases the levels of circulating fatty acids that repress the action of insulin and cause insulin resistance in pregnant females which appear to play a crucial role in the pathogenesis of gestational diabetes mellitus.
Phase
N/ASpan
57 weeksSponsor
Kafrelsheikh UniversityCairo
Recruiting
Evaluation of the Effect of Micro-osteoperforation on the Rate of Bone Anchored Molar Distalization
The design of this randomized controlled clinical trial is a parallel group, two arms trial - Preparatory phase - Self-drilling mini-screws will be placed buccally between upper 2nd premolar and 1st molar bilaterally in the last NiTi wire insertion visit. - After the completion of levelling and alignment phase an intra oral scan will be made for the upper arch and a rigid stainless-steel retraction arch wire 0.017" x 0.025" will be inserted. - The patient will then be referred to the radiology center and a pre-retraction cone beam computed tomography (CBCT) image will be taken for the maxillary arch (T0). - Experimental phase - Subjects will receive MOPs randomly to either the left or right maxillary molar buccal alveolar regions. MOPs will be performed at the first day of the distalization treatment (T0) and will repeated every 2 months. - Molar distalization will started immediately after performing the MOPs using sliding jig distalizer. - The force will be applied to the mini-screw with the sliding jig mechanics on average 300 gm using Nickel-titanium closing coil springs. - Before leaving the clinic, the patient will be asked to: - Use chlorhexidine three times per day for 3 days after MOP applications. - avoid using pain killers (except Panadol when needed). - fill in a Numeric pain rating scale. - Follow up phase - Follow up visits will be scheduled every 4 weeks for reactivation coil spring and check TADs stability. - An intra oral scan for the upper arch will made every visit. - The study time will be continued for 6 months (T1, T2, T3, T4, T5, T6). - The same technique of MOP will be repeated after 2 and 4 months of follow up (T2,T4). - After 6 months of follow up, the final dental model will made, and the patient will be referred to the same radiology center to acquire the post-distalization CBCT.
Phase
N/ASpan
69 weeksSponsor
Cairo UniversityCairo
Recruiting
Healthy Volunteers
Efficacy, Safety and Limitations of Spinal Block for All Infants Under 3 Months
Patients will be carefully examined 24 hours (h) to the procedure and every case will be assessed individually concerning its eligibility for spinal anesthesia under the supervision of a senior pediatric anesthesiologist. History taking and clinical examination along with the necessary laboratory tests . Standard blood test is cbc and we will use it a routine before surgery. About 1 ml blood is needed as a sample. Counseling the parents or the legal guardian regarding every aspect of the procedure and obtaining their informed written consent. All patients will be fasting from formula milk for 6 hours, breast milk for 4 hours and clear fluid for 1 h before anesthesia . No overnight premedication will be given. After the establishment of intravenous access, all patients will be given crystalloid solution (Ringer's solution or Normal Saline) of 10 ml/kg over 30 minutes started with the application of monitors. Heart rate, blood pressure, oxygen saturation. Blood glucose level is measured. The monitors will be connected and pulse oximetry (SPO2) baseline non-invasive blood pressure (NIBP), heart rate (HR), and electrocardiogram (ECG tracings) will be obtained. Fluid bolus of 5 ml/kg will be used for any intraoperative hypotension. Atropine 50µ/kg will be given intravenously if HR dropped > 20% of baseline reading . Intraoperative blood loss will be replaced by 3 times volume with the same crystalloid .blood glucose level is measured after injection then every 30 minutes till end of surgery . All patients will receive spinal anesthesia via midline approach with patients in sitting position established by assistant under complete aseptic conditions. A subcutaneous bleb using Lidocaine 1% through the needle of an insulin syringe followed by minor skin scratch to will help avoiding possible intrathecal dermoid implantation . A lumbar puncture will be performed in L4-L5 or L5- S1 interspace using 25-G 25-mm pencil-point spinal needle . Depth of epidural space is anticipated at 0.1 mm/kg . After getting free flow of cerebrospinal fluid (CSF) hyperbaric bupivacaine (0.5%) in a dose of 0.5 mg/kg (0.1 ml/kg) will be slowly injected in the subarachnoid space . The end of the injection will be taken as time zero for further data recording. Since the Bromage score is not assessable among this pediatric population, the success of the spinal anesthesia is estimated and based on the presence of profound motor block (unable to move feet, knees and legs) in the lower extremities and the absence of a skin prick response using toothed forceps at the appropriate dermatome level. If these signs will not confirmed after 5 min, general anesthesia will be performed . All of these cases will be registered as spinal block failure Then pacifier dipped with sugar water will be offered to the baby. Throughout the operation, the effect of the spinal anesthesia will be monitored till return of spontaneous movement or response to surgical stimulus then sevoflurane mask will be applied and surgery continues either mask or even intubation then mean time of conversion to general anesthesia will be recorded and registered as spinal block failure. Complications from SA: Hypotension is defined as a more than 20%decrease in mean blood pressure from baseline. (Mean blood pressure =post conceptual age in weeks ). Bradycardia is defined as a heart rate less than 120 b/min or HR dropped > 20% of baseline reading) Apnea is defined as a sustained respiratory pause of 15 s or longer or less than15s if accompanied by oxygen saturation (SpO2) less than 90% or bradycardia. Hypoxemia is defined as oxygen saturation below 90% . High spinal block is defined as apnea after spinal injection without sedative drugs and/or motor block of the upper extremities and no response to hand finger pinprick All this complications will be monitored intra and postoperatively and managed accordingly. All patients will be admitted postoperative for 12 hours in the hospital. Post operative cbc also a routine blood test will be done .The conductors of this study will record the degree of motor block and pain. The pain control will be measured using the Face, Legs, Activity, Crying, and Controllability (FLACC) pain score (0-10 score range) . The FLACC score will be evaluated and recorded during the first 12h immediately postoperative and at 2, 4, 6, 12 hours postoperatively. The time of giving analgesia (intravenous paracetamol 15 mg/kg) will be recorded when the FLACC score exceeds 4, with a maximum of four doses per day, and total paracetamol consumption will be recorded . It is given that pain medications will be given when the FLACC score exceeds 4 at assessment or in between of the allotted time interval.
Phase
N/ASpan
57 weeksSponsor
Ain Shams UniversityCairo
Recruiting
Periodontal Health and Patient Satisfaction of CAD/CAM Fiber-Reinforced vs. PFM Attachments in Distal Extension RPDs
Twelve participants with bilateral maxillary Kennedy Class I, with the first premolars as the last standing abutments, will be recruited based on strict inclusion criteria from the oral and maxillofacial prosthodontic outpatient clinic. The canines and first premolars will be prepared to receive OT extracoronal attachments made from either CAD/CAM fiber-reinforced composite (Group I) or porcelain-fused-to-metal (Group II), according to group allocation. All participants will then receive a metallic removable partial denture. Periodontal health will be assessed through bleeding index, probing depth, and gingival recession at denture insertion and after six months. Patient satisfaction will also be evaluated at the six-month follow-up.
Phase
N/ASpan
39 weeksSponsor
Ain Shams UniversityCairo
Recruiting
Healthy Volunteers
Effect of Melatonin on Postoperative Pain After Simple Nephrectomy
This study will be conducted in Cairo University Hospitals at Uorolgy OR. This study will include 40 patients divided into two groups, aged 18 to 65 years, both sexes, belonging to the American Society of Anesthesiologists (ASA) physical status I, II undergoing simple nephrectomy. 1. Inclusion criteria - Age from 18 to 65 years. - Both sexes. - (ASA) physical status I, II. - Patients undergoing simple nephrectomy. 2. Exclusion criteria - Patient refusal. - Patients with a history of allergic reactions to melatonin. - Patients receiving drugs with known analgesic and sedative properties. - Body Mass Index (BMI) over 30 kg/m2. - Drug or alcohol abuse. - History of cardiovascular disease. - Renal Failure. - Mental impairment. - Renal impairment. Medical and surgical history of the patients will be taken, clinical examination of the patients will be performed and routine laboratory investigations as CBC, coagulation studies, renal function and liver function will be done. Preoperative visit will be conducted the day before surgery. All patients will be evaluated by the same anesthesia resident, who provided information on the preoperative course and instructed them on the procedure. Each patient will be instructed about postoperative pain assessment with the visual analog scale (VAS) which [0 represents "no pain" while 10 represents "the worst pain imaginable"] and level of anxiety. Intraoperative management All patients will be connected to standard monitoring which include electrocardiography (ECG), non-invasive arterial blood pressure (NIBP), pulse oximetry, temperature probe, and capnography (will be connected after induction of general anesthesia). Induction of general anesthesia will be done after inserting 20G venous cannula by IV propofol 2-2.5 mg / kg and IV fentanyl 2ug / kg. After IV Atracurium 0.5mg / kg, endotracheal intubation will be done. Maintenance of anesthesia will be isoflurane (1-1.5%) with 50-100% oxygen. Incremental doses of IV Atracurium 0.1mg/Kg will be given every 20 min. Patients will be mechanically ventilated and end-tidal CO2 will be maintained between 35-45 mmHg. Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain). At the end of the surgery, inhalational anesthetics will be stopped waiting for motor power and conscious level to be regained. Then the reversal will be given IV Neostigmine 0.03-0.07 mg/kg + Atropine 0.02 mg/kg. A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. Rescue analgesia of morphine will be given as 3 mg bolus if the VAS > 3 to be repeated after 30 min if pain persists until the VAS < 4. VAS will be assessed at 0, 2, 4, 6, 8, 12, 18, and 24 h postoperatively. The adverse effects will be assessed: hypotension (decrease in basal mean arterial blood pressure by 20%) will be treated with I.V. fluid, bradycardia (defined by decrease in basal heart rate by 20%) will be treated by I.V. atropine 0.02 mg/kg, respiratory depression (the SpO2 < 95% and need O2 supplementation), and 4 mg of ondansetron every 6 hours will be administered for postoperative nausea/vomiting (PONV) as required.
Phase
1Span
18 weeksSponsor
Cairo UniversityCairo
Recruiting
Healthy Volunteers
Ultrasound-Guided Erector Spinae Plane Block Versus Modified Thoracoabdominal Block for Analgesia in Obese Patients
Patients will be randomly allocated into two groups: ESPB (n=20) and M TAPA (n=20). 1. ESPB group: This group will receive ultrasound guided erector spinae plane block. 2. M-TAPA group: This group will receive ultrasound guided modified thoracoabdominal nerve block. Preoperative assessment: The patient will enter the preparation room, he/she will be asked about his medical and surgical history in details and fasting hours (6-8 hrs) and full examination will be performed including airway examination. Lab investigations including complete blood count (CBC), coagulation profile, liver function tests and renal function tests will be checked. The procedure will be explained to the patient and informed consent will be signed after his agreement then the patient will be classified into one of the groups. The VAS will be explained to the patient in details as it will be used as a measurement tool for assessment of postoperative pain. Operating Room preparation & Equipment: The ultrasound used will be Siemens ACUSON X300 Ultrasound System, the scanning probe was a linear probe 8-14 MHZ. A 50-mm block needle 22 gauge will be used. (SonoPlex Stim Cannula, Germany) All blocks will be given by one researcher using 40ml of drug 0.25% bupivacaine (20ml on each side) Intraoperative management: After that, the patient will be monitored with electrocardiogram (ECG), non-invasive arterial blood pressure, pulse oximetry, oxygen saturation (SpO2) and Capnography. IV access will be secured with 18-gauge cannula and Premedication (ranitidine 2.0 mg/kg IV and metoclopramide 0.1 mg/kg IV) will be given. Predicted body weight will be used for calculation of drug dose. A) In ESPB group: - The patient will assume the sitting position with an assisting nurse for support and to ensure patient's safety. - A single anesthesiologist will perform ESPB on both sides of the body. - The level of T10 will be determined by counting 3 spinous processes below T7 (which is at the level of the inferior angle of the scapula), and will also be double-checked by counting down from C7. - Before applying the block, the spinous process of the spine and a spot 3 cm laterally from it are indicated. - The probe will then be lateralized 2.5-3 cm into the parasagittal plane. - The needle will be placed and advanced under sono-vision until it contacts the transverse process of the T10 vertebra after being visible to the Trapezius, Rhomboid Major, Erector Spinae muscle, and these structures. - No sedation will be used. - Utilizing aseptic methods, subcutaneous local apathetic infiltration of lidocaine will be performed using insulin syringe. - After negative aspiration, LA will be deposited deep to the erector spinae muscle in the fascial plane. - After that, a 22-gauge spinal needle will be used to inject 20 ml of bupivacaine 0.25% and 5 ml of lidocaine 2% as local anesthesia (LA) on each side. B) M TAPA group : - The patient will assume the supine position with an assisting nurse for support and to ensure patient's safety. - A single anesthesiologist will perform M-TAPA on both sides of the body. - Transversus abdominis, internal oblique and external oblique muscles will be located with a high-frequency linear probe on the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal margin. - In order to see the lower surface of the costal cartilage in the midline, a deep angle will be made to the costochondral angle at the margin of the 10th costa. - Utilizing aseptic methods, subcutaneous local apathetic infiltration of lidocaine will be performed using insulin syringe. - After negative aspiration, using the in-plane approach, a 22-gauge spinal needle will be placed in the cranial direction, and the needle's tip will then be advanced to the posterior aspect of the 10th costal cartilage. - The 10th costal cartilage's cranial edge will be never passed by the needle tip, and 20 mL of 0.25% bupivacaine will be injected into the chondrium's lower surface. - For the other side, the identical procedure will be repeated. C) After blocks, the onset of general anesthesia will be achieved after intubation, surgical sterilization, draping and positioning. D) All patients will receive general anaesthesia (GA). Anaesthesia will be induced with propofol (2 mg/kg), fentanyl (2 μg/kg) and atracurium (0.5 mg/kg). The GA will be maintained by isoflurane (1.2 %) and atracurium (0.1 mg/kg/20 min). E) Intraoperative vital signs as heart rate, blood pressure and intraoperative opioid requirements will be recorded every 15 minutes till patient recovery. F) After skin closure, muscle relaxation will be reversed using neostigmine (0.04mg/kg) and atropine (0.01mg/kg) after the return of spontaneous breathing. G) Patients will be transferred to the post-anesthesia care unit (PACU) for 60 min for complete recovery and monitoring H) If at any point hypotension occurred (defined as a decrease in mean arterial pressure > 25% from the baseline value or systolic arterial pressure of 100 mmHg), it will be treated with 5 mg of IV bolus ephedrine, which will be repeated every 3 min until the hypotension resolved. Bradycardia (defined as a heart rate (HR) of 40 beats/min) will be treated with intravenous atropine (0.5 mg). I) Within the first 30 minutes, postoperative vital signs (heart rate and blood pressure) and VAS (static and dynamic) for pain will be recorded at 30 minutes, 2, 6, 12, 24 hours and if VAS ≥4 or when the patient asks for analgesia, nalbuphine IV (0.1mg/kg) will be given (rescue analgesia) targeting VAS ≤ 3. The time to first call for analgesia will be recorded. The patient will receive paracetamol (1gm/8hrs IV) as a regular analgesia. If the patient requires more than two doses of rescue analgesia in the first hour following surgery, the block will be deemed to have failed. The inappropriate analgesia will be considered when 120% increase in systolic blood pressure and/or heart rate from baseline in absence of other causes. The intraoperative analgesic management will be achieved using fentanyl bolus of 1 mcg/kg.
Phase
N/ASpan
23 weeksSponsor
Kasr El Aini HospitalCairo
Recruiting
Healthy Volunteers
Immediate Implant Placement Using Xenograft Mixed with Vitamin D Versus Hyaluronic Acid.
Dental implants in fresh extraction sockets and healed sites have a erratic morphology, creating a wide space defect between the implant and buccal alveolar bone. This defect is critical for implant success, known as a jumping gap. Proper management of this space is essential for esthetic and functional success. Studies show adequate bone fill can be achieved in jumping gaps, but wider gaps increase implant body exposure risk. The application of biological mediators embedded in the biomaterial can induce specific cell and tissue response, which can improve bone quality and quantity. Dental research has focused on improving bone substitutes by morphologic or bio- chemical modification.
Phase
N/ASpan
39 weeksSponsor
Cairo UniversityCairo
Recruiting
Healthy Volunteers
Ultrasound Guided Versus Surgical Rectus Sheath Block Versus Local Anesthesia Infiltration for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy
Total abdominal hysterectomy (TAH) is a commonly performed major surgical procedure that results in substantial postoperative pain and discomfort. Local anesthetic infiltration (LAI) at the end of surgery is one of the most common technique employed in laparotomies for postoperative analgesia. Rectus sheath block (RSB) has been used as a part of multimodal analgesia, especially when neuraxial techniques are unsuitable.The RSB was used to achieve peri-operative relaxation of the anterior abdominal wall.
Phase
N/ASpan
24 weeksSponsor
Ain Shams UniversityCairo
Recruiting
Lidocaine and Dexmedetomidine Infusion and Their Combination on Perioperative Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure allowing the reduction of surgical stress. However, postoperative pain management is crucial for patients undergoing VATS, as inadequate pain control can lead to complications (such as lung atelectasis), prolonged recovery, and decreased patient satisfaction. Dexmedetomidine has shown positive effects on postoperative pain intensity, opioid consumption and other recovery parameters, such as postoperative nausea and vomiting (PONV), and speed of recovery. Lidocaine has exhibited an excellent safety profile when administered as a low-dose infusion for cancer or non-cancer chronic pain.
Phase
N/ASpan
24 weeksSponsor
Ain Shams UniversityCairo
Recruiting