Postoperative Pain Relief After Major Abdominal Gynecological Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: postoperative analgesic methods


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lumbar epidural analgesia<br>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: postoperative analgesic methods<br>* lumbar epidural analgesia Transversus abdominis plane block wound infiltration<br>|
| Active Comparator: transversus abdominis plane block<br>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: postoperative analgesic methods<br>* lumbar epidural analgesia Transversus abdominis plane block wound infiltration<br>|
| Active Comparator: wound infiltration<br>For postoperative analgesia; After the end of surgery but before extubation, 0.125% bupivacaine 20 ml administered to the surgical incision site. | Procedure: postoperative analgesic methods<br>* lumbar epidural analgesia Transversus abdominis plane block wound infiltration<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores | 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 | patient satisfaction scores were recorded using patient satisfaction scale (0= worst, 10=excellent) | postoperative 24 and 48 hours | 
| 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. | postoperative 48 hours | 
| side effects | all patients were visited after surgery in the ward and side effects were evaluated and recorded | postoperative 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural analgesia, pain score, morphine, transversus abdominis plane block, wound infiltration