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

NCT02752971 | Completed Phase 3

• 1 other identifier: Sodium Diclofenac in wounds
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (4)

• rest and dynamic postoperative pain with visual analogue scale

  24 hours of postoperative period

• rescue analgesic consumption

  24 hours of postoperative period

• appearance of bowel sounds

  auscultation of bowel sounds

  24 hours of postoperative period

• changes in rest and dynamic postoperative pain with visual analogue scale

  24 hours of postoperative pain

Secondary Outcomes (1)

• number of participants with skin suture removal after 10 days

  10 days of postoperative pain

Study Arms (3)

Bupivacaine

EXPERIMENTAL

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

Drug: Bupivacaine

Bupivacaine, sodium diclofenac

EXPERIMENTAL

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

Sodium diclofenac

EXPERIMENTAL

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

Interventions

Bupivacaine DRUG

Bupivacaine; Bupivacaine, sodium diclofenac

Sodium diclofenac DRUG

Bupivacaine, sodium diclofenac; Sodium diclofenac

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society Anesthesiologist I- II
• aged 18 and 65
• both sexes
• patients diagnosed with acute appendicitis operated under general anesthesia

You may not qualify if:

• Patients known to any allergy of the drugs used in the study
• Different incision approach Mc Burney
• Some intraoperative surgical complications
• Pregnant patients

Sponsors & Collaborators

• Hospital Central Dr. Luis Ortega: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Diclofenac

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 20, 2016
• First Posted: April 27, 2016
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Last Updated: April 27, 2016

Record last verified: 2016-04