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

Study Overview
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Sodium diclofenac


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivacaine<br>A dilution of Bupivacaine 0,25% , 15 ml was infiltrated in surgical wound after close the aponeurosis | Drug: Bupivacaine<br> <br> |
| Experimental: Bupivacaine, sodium diclofenac<br>A dilution of Bupivacaine 0,25% and sodium diclofenac 75 mgr, was infiltrated in surgical wound after close the aponeurosis | Drug: Bupivacaine<br> <br> Drug: Sodium diclofenac<br> <br> |
| Experimental: Sodium diclofenac<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with skin suture removal after 10 days |  | 10 days of postoperative pain |