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Trial record 6 of 453 for:    DICLOFENAC

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

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ClinicalTrials.gov Identifier: NCT02752971
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Beatriz Arismendi Gómez, Hospital Central Dr. Luis Ortega

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Bupivacaine Drug: Sodium diclofenac Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Surgical Wound Infiltration With Sodium Diclofenac Versus Bupivacaine in the Treatment of Acute Postoperative Pain Following Appendectomy
Study Start Date : February 2015
Actual Primary Completion Date : February 2016


Arm Intervention/treatment
Experimental: Bupivacaine
A dilution of Bupivacaine 0,25% , 15 ml was infiltrated in surgical wound after close the aponeurosis
Drug: Bupivacaine
Experimental: Bupivacaine, sodium diclofenac
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
Experimental: Sodium diclofenac
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



Primary Outcome Measures :
  1. rest and dynamic postoperative pain with visual analogue scale [ Time Frame: 24 hours of postoperative period ]
  2. rescue analgesic consumption [ Time Frame: 24 hours of postoperative period ]
  3. appearance of bowel sounds [ Time Frame: 24 hours of postoperative period ]
    auscultation of bowel sounds

  4. changes in rest and dynamic postoperative pain with visual analogue scale [ Time Frame: 24 hours of postoperative pain ]

Secondary Outcome Measures :
  1. number of participants with skin suture removal after 10 days [ Time Frame: 10 days of postoperative pain ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Beatriz Arismendi Gómez, Medical Doctor, Hospital Central Dr. Luis Ortega
ClinicalTrials.gov Identifier: NCT02752971     History of Changes
Other Study ID Numbers: Sodium Diclofenac in wounds
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Diclofenac
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action