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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02752971
Acronym
diclofenac
Enrollment
43
Registered
2016-04-27
Start date
2015-02-28
Completion date
Unknown
Last updated
2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

DRUGBupivacaine
DRUGSodium diclofenac

Sponsors

Hospital Central Dr. Luis Ortega
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
rest and dynamic postoperative pain with visual analogue scale24 hours of postoperative period
rescue analgesic consumption24 hours of postoperative period
appearance of bowel sounds24 hours of postoperative periodauscultation of bowel sounds
changes in rest and dynamic postoperative pain with visual analogue scale24 hours of postoperative pain

Secondary

MeasureTime frame
number of participants with skin suture removal after 10 days10 days of postoperative pain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026