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

Hospital Central Dr. Luis Ortega

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Bupivacaine; Drug: Sodium diclofenac

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

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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