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

• Sponsor: Hospital Central Dr. Luis Ortega (Other)
• Overall Status: Completed
• CT.gov ID: NCT02752971
• Collaborator: (none)
• Enrollment: 43
• Arms: 3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Bupivacaine; Drug: Sodium diclofenac	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Surgical Wound Infiltration With Sodium Diclofenac Versus Bupivacaine in the Treatment of Acute Postoperative Pain Following Appendectomy
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bupivacaine A dilution of Bupivacaine 0,25% , 15 ml was infiltrated in surgical wound after close the aponeurosis	Drug: Bupivacaine
Experimental: Bupivacaine, sodium diclofenac A dilution of Bupivacaine 0,25% and sodium diclofenac 75 mgr, was infiltrated in surgical wound after close the aponeurosis	Drug: Bupivacaine; Drug: Sodium diclofenac
Experimental: Sodium diclofenac A dilution of sodium diclofenac 75 mgrs (3ml) and 12 ml of solution 0,9% was infiltrated in surgical wound after close the aponeurosis	Drug: Sodium diclofenac

Outcome Measures

Primary Outcome Measures

1. rest and dynamic postoperative pain with visual analogue scale [24 hours of postoperative period]

2. rescue analgesic consumption [24 hours of postoperative period]

3. appearance of bowel sounds [24 hours of postoperative period]

   auscultation of bowel sounds

4. changes in rest and dynamic postoperative pain with visual analogue scale [24 hours of postoperative pain]

Secondary Outcome Measures

1. number of participants with skin suture removal after 10 days [10 days of postoperative pain]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital Central Dr. Luis Ortega

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beatriz Arismendi Gómez, Medical Doctor, Hospital Central Dr. Luis Ortega
• ClinicalTrials.gov Identifier: NCT02752971
• Other Study ID Numbers: Sodium Diclofenac in wounds
• First Posted: Apr 27, 2016
• Last Update Posted: Apr 27, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Pain, Postoperative; Diclofenac; Bupivacaine

Study Results

No Results Posted as of Apr 27, 2016