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

Postoperative Pain Clinical Trial

— diclofenac  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752971
• Other study ID #: Sodium Diclofenac in wounds
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2016
• Last updated: April 26, 2016
• Start date: February 2015

Study information

• Verified date: April 2016
• Source: Hospital Central Dr. Luis Ortega
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela: Ministry of Health and Social Development
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bupivacaine

• Sodium diclofenac

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Central Dr. Luis Ortega

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rest and dynamic postoperative pain with visual analogue scale		24 hours of postoperative period	No
Primary	rescue analgesic consumption		24 hours of postoperative period	No
Primary	appearance of bowel sounds	auscultation of bowel sounds	24 hours of postoperative period	No
Primary	changes in rest and dynamic postoperative pain with visual analogue scale		24 hours of postoperative pain	No
Secondary	number of participants with skin suture removal after 10 days		10 days of postoperative pain	No