Comparative Study Between Two Adjuvant Drugs to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries

Last updated: July 13, 2022
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05323214
FMASU MD 121/2021
  • Ages 21-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Epidural analgesia is associated with early postoperative mobilization and rehabilitation with minimally associated pain and discomfort. Analgesic effect of local anesthetics is augmented by addition of adjuvants in epidural anesthesia ensuring satisfactory postoperative period. This study evaluates the effect of dexmedetomidine and fentanyl as additives to bupivacaine for epidural analgesia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ASA I or ASA II patients.
  • Age group: 21-70 years old.
  • BMI ≤40
  • Duration of procedure ≤ 180 minutes.

Exclusion

Exclusion Criteria:

  • Patients with known neurologic and psychiatric illness will be excluded from thestudy.
  • Contraindications for epidural anesthesia as patient refusal, bleeding or coagulationtest abnormalities, local skin infection at spinal lumbar region, raised intracranialpressure and hypovolemia
  • Spine abnormalities.
  • Systemic disorders like hematological, respiratory, cardiac, renal or hepaticinsufficiency.
  • Allergy to any of the drugs used in the study.

Study Design

Total Participants: 75
Study Start date:
August 01, 2021
Estimated Completion Date:
September 30, 2022

Study Description

The aim of the study is to evaluate the effect of dexmedetomidin and fentanyl as adjuvants to bupivacaine for postoperative epidural analgesia in abdominal surgeries regarding block characteristics, post-operative analgesia, hemodynamic changes and any anticipated side effects.

  • Type of Study: Prospective randomized comparative clinical study.

  • Study Setting: The operating theatres of Ain Shams University Hospitals

  • Study Period: One year

  • Sampling Method: Random sampling Patients randomly allocated by computer generated randomization and using opaque sealed envelopes to one of the three study groups according to the adjuvant drug used in postoperative analgesia.

  • Sample Size: Total 75 cases divided into 25 cases in each group. Kiran et al. (2018) reported a rather large effect size comparing onset to sensory block and time to maximum motor block. In a one-way ANOVA study, sample sizes of 25 cases per group in three groups whose means are to be compared. The total sample of 75 subjects achieves 80% power to detect differences among the means versus the alternative of equal means using an F test with a 0.0500 significance level. The size of the variation in the means is represented by the effect size = 0.4

Connect with a study center

  • Ain Shams University Hospitals

    Cairo,
    Egypt

    Active - Recruiting

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