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

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Procedure: TAP Blocks; Procedure: continuous epidural infusion

• Registration Number: NCT03154463
• Lead Sponsor: Indonesia University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-16
• Study Start: 2017-09-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-01-31
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP blocks	TAP Blocks	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)
continuous epidural infusion	continuous epidural infusion	Epidural group received epidural regional anesthesia in sitting position, with epidural regimen of 0.25% bupivacaine without any adjuvant

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cipto Mangunkusumo Central National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia