Multi-Drug Analgesia vs. Standard Solution for Anal Surgery

Last updated: July 21, 2017
Sponsor: Columbia University
Overall Status: Trial Not Available

Phase

4

Condition

Hemorrhoids

Rectal Disorders

Treatment

N/A

Clinical Study ID

NCT03105674
AAAQ9398
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary aim is to test the magnitude and duration of analgesia provided by single dose multi-drug analgesia administered for perianal block, and compare with standard solution (Marcaine & Lidocaine in 1:1 mixture - Total 60 ml), at post-operative period and also to compare with the standard solution including their respective post-operative opioid or non-opioid oral analgesic requirement. Local anesthesia via a perianal block using multi-drug analgesia or standard solution will be compared using the Numeric pain rating scale on Post-operative day 1, 3 and during follow up visit on day 7. The investigators hope to find a better control of post-operative analgesia which will lead to better functional outcomes. Possible decrease consumption of opioids in the post-operative period will perhaps decrease the cost and chances of addiction and will increase patient comfort and compliance.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and nonpregnant women aged 18 years or older scheduled to undergo anorectalprocedures

  • Female patients must be postmenopausal, surgically sterile, or willing to useacceptable means of contraception for at least 30 days after surgery.

  • Patients will be required to have an Americal society of anesthesia physical statusclassification of 1, 2, or 3.

Exclusion

Exclusion Criteria:

  • Patients with concurrent or recent medical conditions that might interfere with studyparticipation, including history of hepatitis, alcohol/substance abuse, uncontrolledpsychiatric disorders, known allergy, or contraindication to amide-type localanesthetics, opioids, or propofol.

  • Patients who are participating in another study involving an investigationalmedication within the prior 30 days, or were taking analgesics (ie, non- steroidalanti-inflammatory drugs, acetaminophen, or opioids), antidepressants, orglucocorticoids within the 3 days before surgery.

Study Design

Study Start date:
May 01, 2017
Estimated Completion Date:
December 31, 2017

Study Description

Post-operative analgesia after anorectal surgery still poses a significant problem. Technical or operator dependent factors have been proposed for causing severe pain post operatively. Many factors such as height of anastomosis, incorporation of smooth muscle, size of doughnut, and inclusion of squamous epithelium were considered to cause pain specially after hemorrhoidectomy. However, in spite of standardizing the techniques, patients still experience moderate to severe pain after anorectal surgery. Effective post-surgical pain control is critical to patient recovery, and can contribute to improved healing, faster patient mobilization, reduced hospital stays and health care costs. Effective multimodal techniques have been devised to maximize pain relief, lower the risk of adverse events, and improve patient outcomes. These techniques (wound infiltration with local anesthetic being most common) is short lived, maximum up to 12 hours. Post-operative pain usually lasts for 72 hours and thus the systemic opioids remain the mainstay pain control post-operatively. Although effective analgesics, they are associated with unwanted and potentially adverse events, such as nausea, vomiting, pruritus, sedation, cognitive impairment, urinary retention, sleep disturbances, and respiratory depression. Also, narcotic addiction remains a concern for surgical patients. Some patients would like to have effective analgesia and thus also avoid narcotics.Multi-drug analgesic combinations are used in orthopedic surgery (Ropivacaine, Ketorolac, and Morphine, with adrenaline) and during hemorrhoidectomy (extended-release liposome Bupivacaine) which showed decrease in post-operative analgesia requirement. However, no studies that used multi-drug analgesia show any effect on the pain medication consumption after discharge for ambulatory surgery. The investigators have designed a novel multi-drug anesthetic formulation to achieve long-acting postoperative analgesia with single-dose administration intra-operative via perianal block and wound infiltration.

Connect with a study center

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.