Postoperative Pain Relief After Major Abdominal Gynecological Surgery

May 6, 2024 updated by: Hakki Unlugenc, Cukurova University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Adana, Turkey
        • Recruiting
        • Çukurova University
      • Adana, Turkey, 01130
        • Recruiting
        • Çukurova University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lumbar epidural analgesia with bupivacaine
For postoperative analgesia; Lumbar epidural catheter inserted at L3-4 or L4-5 epidural space before anesthesia induction in the sitting position. After the end of surgery but approximately 20 minutes before extubation, 0.125% bupivacaine 20 ml administered through epidural catheter and the catheter was removed.
Procedure: lumbar epidural analgesia with bupivacaine
postoperative analgesic method
Active Comparator: transversus abdominis plane block with bupivacaine
For postoperative analgesia; After the end of surgery but before extubation, USD-guided TAP block was performed with 0.125% bupivacaine 20 ml to the anatomic neurofacial space between the internal oblique and transersus abdominis muscles, bilaterally (10 ml for each side).
Procedure: transversus abdominis plane block with bupivacaine
postoperative analgesic method
Active Comparator: wound infiltration with bupivacaine
For postoperative analgesia; After the end of surgery but before extubation, 0.125% bupivacaine 20 ml administered to the surgical incision site.
Procedure: wound infiltration with bupivacaine
postoperative analgesic method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change from baseline morphine comsumption at 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain scores
Time Frame: change from baseline pain scores at 48 hours
postoperative pain scores of the patients were recorded using visual analog scale (VAS; 0=no pain, 10=worst pain)
change from baseline pain scores at 48 hours
patient satisfaction score
Time Frame: postoperative 24 and 48 hours
patient satisfaction scores were recorded using patient satisfaction scale (0= worst, 10=excellent)
postoperative 24 and 48 hours
time to first rescue analgesic
Time Frame: postoperative 48 hours
If the patients complained of pain despite the analgesia regimen, iv 50 mg meperidine was given as a rescue analgesic.
postoperative 48 hours
side effects
Time Frame: postoperative 48 hours
all patients were visited after surgery in the ward and side effects were evaluated and recorded
postoperative 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Study Chair: Hakkı Unlugenc, Proffessor, Çukurova University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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