Analgesic Effect of Three-point Transversus Abdominis Plane Block Compared With Continuous Epidural Infusion for Post-laparoscopic Nephrectomy

Study Overview
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Brief Summary
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This study aimed to compare the efficacy three-point Transversus Abdominis Plane (TAP) blocks with continuous epidural infusion for alleviating pain post-laparoscopic nephrectomy

Detailed Description
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Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Intravenous (IV) cannula, non-invasive blood pressure monitor, and pulse-oxymetry were set on the subjects in endoscopic room. Vital signs were recorded. Subjects were then randomized into two groups (three-point Transversus Abdominis Plane [TAP] blocks and continuous epidural infusion). The epidural group was received epidural regional anesthesia in sitting position before anesthesia induction, between the first and second lumbar vertebra, with 4 cm depth. The TAP group was received TAP block using ultrasound as a guide and injected in three points on trans abdominal plane using 100 mm stimuplex needle and 0.25% bupivacaine with total volume of 20 ml in each point (with total of 60 ml in three points) after the surgery has ended, before the patient was awake. Subjects were given midazolam 0.05 mg/kg body weight (BW) and fentanyl 1-2 µg/kg BW as premedication. Induction was done using propofol 1-2mg/kg BW. Endotracheal intubation was facilitated using atracurium 0.5 mg/kg BW. General anesthesia was maintained using oxygen, air, and sevoflurane. Mechanical ventilation was set with volume control ventilation, Positive End-Expiratory Pressure (PEEP) 5 cm of water, and oxygen fraction of 30-50%. Respiratory rate was set at certain level until the end-tidal carbon dioxide (CO2) value reached around 35-45 mm Hg. During the surgery, the epidural group only received epidural regimen of 0.25% bupivacaine without any adjuvant, while the TAP group received fentanyl and atracurium if needed. After the surgery ended, subjects were prepared for ventilator weaning and extubation. After the subjects were moved to ward, both groups received additional analgesic consisting of fentanyl with patient-controlled analgesia (PCA) method. Total PCA requirements and visual analog scale (VAS) were recorded in the first 24 hours.

Official Title
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Analgesic Effect of Three-point Transversus Abdominis Plane Block Compared With Continuous Epidural Infusion for Post-laparoscopic Nephrectomy

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Procedure: TAP Blocks
* Procedure: continuous epidural infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were going to donate their kidney with laparoscopic nephrectomy surgery. Patients who undergo surgery with supine position. Patients who agreed to participate in this study. Exclusion Criteria: Subjects with contraindications for TAP blocks or continuous epidural anesthesia, such as infection at the site of injection and blood coagulation disorder Drop out Criteria: Complications such as systemic allergy, anaphylaxis, and cardiac arrest occurs
Sexes Eligible for Study
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All

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP blocks<br>TAP group was received TAP block using ultrasound as a guide and injected on three points on trans abdominal plane using 100 mm stimuplex needle and 0.25% bupivacaine with total volume of 20 ml in each point (with total of 60 ml in three points) | Procedure: TAP Blocks<br>* TAP blocks were performed using ultrasound as a guide and injected on three points on trans abdominal plane using 100 mm stimuplex needle and 0.25% bupivacaine with total volume of 20 ml in each point (with total of 60 ml in three points)<br>|
| Active Comparator: continuous epidural infusion<br>Epidural group received epidural regional anesthesia in sitting position, with epidural regimen of 0.25% bupivacaine without any adjuvant | Procedure: continuous epidural infusion<br>* Continuous epidural infusion was given with epidural regimen of 0.25% bupivacaine without any adjuvant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total PCA Morphine consumption (in mcg) | Total PCA morphine consumption (in mcg) by subjects at 2,4,6,12, and 24 hours post-operative | Day 1 | 
| Visual Analog Score | Visual analog scale at 2,4,6,12, and 24 hours post-operative | Day 1 |