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Postoperative Pain Relief After Major Abdominal Gynecological Surgery

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
postoperative analgesic methods
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring epidural analgesia, pain score, morphine, transversus abdominis plane block, wound infiltration

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

lumbar epidural analgesia

transversus abdominis plane block

wound infiltration

Arm Description

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.

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).

For postoperative analgesia; After the end of surgery but before extubation, 0.125% bupivacaine 20 ml administered to the surgical incision site.

Outcomes

Primary Outcome Measures

morphine consumption
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 Outcome Measures

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

Full Information

First Posted
April 26, 2023
Last Updated
April 26, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05845385
Brief Title
Postoperative Pain Relief After Major Abdominal Gynecological Surgery
Official Title
Comparison of Lumbar Epidural Analgesia, Transversus Abdominis Plane Block and Wound Infiltration for Postoperative Pain Relief in Major Abdominal Gynecological Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
epidural analgesia, pain score, morphine, transversus abdominis plane block, wound infiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lumbar epidural analgesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
transversus abdominis plane block
Arm Type
Active Comparator
Arm Description
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).
Arm Title
wound infiltration
Arm Type
Active Comparator
Arm Description
For postoperative analgesia; After the end of surgery but before extubation, 0.125% bupivacaine 20 ml administered to the surgical incision site.
Intervention Type
Procedure
Intervention Name(s)
postoperative analgesic methods
Intervention Description
lumbar epidural analgesia Transversus abdominis plane block wound infiltration
Primary Outcome Measure Information:
Title
morphine consumption
Description
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.
Time Frame
change from baseline morphine comsumption at 48 hours
Secondary Outcome Measure Information:
Title
pain scores
Description
postoperative pain scores of the patients were recorded using visual analog scale (VAS; 0=no pain, 10=worst pain)
Time Frame
change from baseline pain scores at 48 hours
Title
patient satisfaction score
Description
patient satisfaction scores were recorded using patient satisfaction scale (0= worst, 10=excellent)
Time Frame
postoperative 24 and 48 hours
Title
time to first rescue analgesic
Description
If the patients complained of pain despite the analgesia regimen, iv 50 mg meperidine was given as a rescue analgesic.
Time Frame
postoperative 48 hours
Title
side effects
Description
all patients were visited after surgery in the ward and side effects were evaluated and recorded
Time Frame
postoperative 48 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study was conducted on female patients undergoing major abdominal gynecological surgery.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakkı Unlugenc, Proffessor
Organizational Affiliation
Cukurova University
Official's Role
Study Chair
Facility Information:
Facility Name
Cukurova University
City
Adana
Country
Turkey

12. IPD Sharing Statement

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Postoperative Pain Relief After Major Abdominal Gynecological Surgery

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