Postoperative Pain Relief After Major Abdominal Gynecological Surgery

Not Applicable

Recruiting

• Conditions: Postoperative Pain
• Interventions: Procedure: lumbar epidural analgesia with bupivacaine; Procedure: transversus abdominis plane block with bupivacaine; Procedure: wound infiltration with bupivacaine

• Registration Number: NCT05845385
• Lead Sponsor: Cukurova University

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.

Study Timeline

• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-04-26
• Study First Posted: 2023-05-06
• Status Verified: 2024-05
• Study Start: 2024-05-06
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-08-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lumbar epidural analgesia with bupivacaine	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.
transversus abdominis plane block with bupivacaine	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).
wound infiltration with bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
morphine consumption	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 Outcome Measures

Name	Time	Method
pain scores	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)
side effects	postoperative 48 hours	all patients were visited after surgery in the ward and side effects were evaluated and recorded
patient satisfaction score	postoperative 24 and 48 hours	patient satisfaction scores were recorded using patient satisfaction scale (0= worst, 10=excellent)
time to first rescue analgesic	postoperative 48 hours	If the patients complained of pain despite the analgesia regimen, iv 50 mg meperidine was given as a rescue analgesic.

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Turkey