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

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Bupivacaine

Sodium diclofenac

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Bupivacaine

Bupivacaine, sodium diclofenac

Sodium diclofenac

Arm Description

A dilution of Bupivacaine 0,25% , 15 ml was infiltrated in surgical wound after close the aponeurosis

A dilution of Bupivacaine 0,25% and sodium diclofenac 75 mgr, was infiltrated in surgical wound after close the aponeurosis

A dilution of sodium diclofenac 75 mgrs (3ml) and 12 ml of solution 0,9% was infiltrated in surgical wound after close the aponeurosis

Outcomes

Primary Outcome Measures

rest and dynamic postoperative pain with visual analogue scale

rescue analgesic consumption

appearance of bowel sounds

auscultation of bowel sounds

changes in rest and dynamic postoperative pain with visual analogue scale

Secondary Outcome Measures

number of participants with skin suture removal after 10 days

Full Information

NCT ID

NCT02752971

First Posted

March 20, 2016

Last Updated

April 26, 2016

Sponsor

Hospital Central Dr. Luis Ortega

1. Study Identification

Unique Protocol Identification Number

NCT02752971

Brief Title

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

Acronym

diclofenac

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Central Dr. Luis Ortega

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bupivacaine

Arm Type

Experimental

Arm Description

A dilution of Bupivacaine 0,25% , 15 ml was infiltrated in surgical wound after close the aponeurosis

Arm Title

Bupivacaine, sodium diclofenac

Arm Type

Experimental

Arm Description

A dilution of Bupivacaine 0,25% and sodium diclofenac 75 mgr, was infiltrated in surgical wound after close the aponeurosis

Arm Title

Sodium diclofenac

Arm Type

Experimental

Arm Description

A dilution of sodium diclofenac 75 mgrs (3ml) and 12 ml of solution 0,9% was infiltrated in surgical wound after close the aponeurosis

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Intervention Type

Drug

Intervention Name(s)

Sodium diclofenac

Primary Outcome Measure Information:

Title

rest and dynamic postoperative pain with visual analogue scale

Time Frame

24 hours of postoperative period

Title

rescue analgesic consumption

Time Frame

24 hours of postoperative period

Title

appearance of bowel sounds

Description

auscultation of bowel sounds

Time Frame

24 hours of postoperative period

Title

changes in rest and dynamic postoperative pain with visual analogue scale

Time Frame

24 hours of postoperative pain

Secondary Outcome Measure Information:

Title

number of participants with skin suture removal after 10 days

Time Frame

10 days of postoperative pain

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

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

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