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

H

Hospital Central Dr. Luis Ortega

Status and phase

Completed
Phase 3

Conditions

Postoperative Pain

Treatments

Drug: Sodium diclofenac
Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02752971
Sodium Diclofenac in wounds

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

43 participants in 3 patient groups

Bupivacaine
Experimental group
Description:
A dilution of Bupivacaine 0,25% , 15 ml was infiltrated in surgical wound after close the aponeurosis
Treatment:
Drug: Bupivacaine
Bupivacaine, sodium diclofenac
Experimental group
Description:
A dilution of Bupivacaine 0,25% and sodium diclofenac 75 mgr, was infiltrated in surgical wound after close the aponeurosis
Treatment:
Drug: Bupivacaine
Drug: Sodium diclofenac
Sodium diclofenac
Experimental group
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
Treatment:
Drug: Sodium diclofenac

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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