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Completed

NCT Number: NCT02752971

Wound Infiltration With Sodium Diclofenac vs Bupivacaine for Postoperative Pain Following Appendectomy

The infiltration of the surgical wound is an effective strategy for postoperative analgesia. Nonsteroidal antiinflammatories are useful in this way.

Objective: To compare the analgesic effectiveness of diclofenac sodium, bupivacaine or bupivacaine plus diclofenac sodium infiltrating wound appendectomies.

Method: Comparative, double blind, American Society Anesthesiologist classification I-II,18-65años. Group 1 (Bupivacaine n = 14), Group 2 (Diclofenac Sodium n = 14), Group 3 (Bupivacaine + Diclofenac Sodium n = 15). Pain at rest and dynamic, rescue analgesic consumption in Post Anesthesia Care Unit (PACU) and 24 hours after surgery were evaluated.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society Anesthesiologist I- II
  • aged 18 and 65
  • both sexes
  • patients diagnosed with acute appendicitis operated under general anesthesia

Exclusion criteria

  • Patients known to any allergy of the drugs used in the study
  • Different incision approach Mc Burney
  • Some intraoperative surgical complications
  • Pregnant patients

Treatment and study plan

Bupivacaine

Drug

Sodium diclofenac

Drug

Primary outcomes

  1. rest and dynamic postoperative pain with visual analogue scale

    Time frame: 24 hours of postoperative period

  2. rescue analgesic consumption

    Time frame: 24 hours of postoperative period

  3. appearance of bowel sounds

    Time frame: 24 hours of postoperative period

    auscultation of bowel sounds

  4. changes in rest and dynamic postoperative pain with visual analogue scale

    Time frame: 24 hours of postoperative pain

Secondary outcomes

  1. number of participants with skin suture removal after 10 days

    Time frame: 10 days of postoperative pain

Sponsors and collaborators

Lead sponsor

Hospital Central Dr. Luis Ortega

Other

Registry information

Official study title

Surgical Wound Infiltration With Sodium Diclofenac Versus Bupivacaine in the Treatment of Acute Postoperative Pain Following Appendectomy

Acronym: diclofenac

Important dates

Study start
2015
Primary completion
2016
First posted
Apr 27, 2016
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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