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Clinical Trials/NCT05845385
NCT05845385
Recruiting
Not Applicable

Comparison of Lumbar Epidural Analgesia, Transversus Abdominis Plane Block and Wound Infiltration for Postoperative Pain Relief in Major Abdominal Gynecological Surgery

Cukurova University1 site in 1 country81 target enrollmentMay 6, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Cukurova University
Enrollment
81
Locations
1
Primary Endpoint
morphine consumption
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The aim of our study was to compare the effects of Lomber Epidural Analgesia (LEA), Transversus Abdominis Plane (TAP) block and Local Anesthetic Infiltration (LAI) on postoperative morphine consumption, time to first recue analgesic request, pain and patient satisfaction scores and side effects were compared in the patients undergoing major gynecologic/oncology lower abdominal surgery.

Detailed Description

Following faculty ethical committee approval and written informed consent, 81 patients were included in our prospective, randomized and double-blind study. Patients were divided into 3 groups: lumbar epidural block (Group E), TAP block (Group T), and wound infiltration (Group I). Demographic data, surgical characteristics, hemodynamic values, pain scores at rest and on movement, morphine consumption, additional analgesic requirement, side effects at 1, 2, 6, 12, 24, 36 and 48th hours after surgery, and patient satisfaction scores at 24 and 48th hours were recorded.

Registry
clinicaltrials.gov
Start Date
May 6, 2024
End Date
September 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hakki Unlugenc

professor

Cukurova University

Eligibility Criteria

Inclusion Criteria

  • ASA I-II,
  • between the age of 18-69,
  • undergoing major gynecological abdominal surgery under general anesthesia

Exclusion Criteria

  • lack of patient consent
  • ASA \> III
  • sensitivity or contraindication to study drugs
  • conditions in which epidural anesthesia is contraindicated
  • emergency and urgent surgery
  • inability to comprehend pain scale
  • any contraindication to the use of patient controlled analgesia (PCA) device.

Outcomes

Primary Outcomes

morphine consumption

Time Frame: change from baseline morphine comsumption at 48 hours

At the end of the surgery, the patients were allowed to use the patient controlled analgesia device (PCA). The PCA (CADD Legacy PCA pump, Smiths Medical MD, Inc. St. Paul, MN) was prepared with 40 mg morphine HCl in 100 ml saline. The PCA doses of morphine consisted of a bolus dose of 0.02 mg/kg every 15 minutes without a background infusion. Morphine consumption (mg) was evaluated and recorded postoperative 48 hours.

Secondary Outcomes

  • time to first rescue analgesic(postoperative 48 hours)
  • pain scores(change from baseline pain scores at 48 hours)
  • side effects(postoperative 48 hours)
  • patient satisfaction score(postoperative 24 and 48 hours)

Study Sites (1)

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