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

NCT ID: NCT02752971

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Bupivacaine

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

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

Bupivacaine, sodium diclofenac

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

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

Sodium diclofenac

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Sodium diclofenac

Intervention Type DRUG

Interventions

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Bupivacaine

Intervention Type DRUG

Sodium diclofenac

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Central Dr. Luis Ortega

OTHER

Sponsor Role lead

Responsible Party

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Beatriz Arismendi Gómez

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Sodium Diclofenac in wounds

Identifier Type: -

Identifier Source: org_study_id

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