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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154463
• Other study ID #: IndonesiaUAnes016
• Status: Completed
• Phase: N/A
• First received: May 11, 2017
• Last updated: February 27, 2018
• Start date: September 1, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: February 2018
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• TAP Blocks
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)
• continuous epidural infusion
Continuous epidural infusion was given with epidural regimen of 0.25% bupivacaine without any adjuvant

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (10)

Bhosale G, Shah V. Combined spinal-epidural anesthesia for renal transplantation. Transplant Proc. 2008 May;40(4):1122-4. doi: 10.1016/j.transproceed.2008.03.027. — View Citation

Biglarnia AR, Tufveson G, Lorant T, Lennmyr F, Wadström J. Efficacy and safety of continuous local infusion of ropivacaine after retroperitoneoscopic live donor nephrectomy. Am J Transplant. 2011 Jan;11(1):93-100. doi: 10.1111/j.1600-6143.2010.03358.x. — View Citation

Gulyam Kuruba SM, Mukhtar K, Singh SK. A randomised controlled trial of ultrasound-guided transversus abdominis plane block for renal transplantation. Anaesthesia. 2014 Nov;69(11):1222-6. doi: 10.1111/anae.12704. Epub 2014 Jun 28. — View Citation

Mathuram Thiyagarajan U, Bagul A, Nicholson ML. Pain management in laparoscopic donor nephrectomy: a review. Pain Res Treat. 2012;2012:201852. doi: 10.1155/2012/201852. Epub 2012 Oct 23. — View Citation

Minnee RC, Idu MM. Laparoscopic donor nephrectomy. Neth J Med. 2010 May;68(5):199-206. Review. — View Citation

Oyen O. Minimally invasive kidney transplantation (MIKT). J Surg Res. 2008 Mar;145(1):4. doi: 10.1016/j.jss.2007.08.001. Epub 2007 Aug 30. — View Citation

SarinKapoor H, Kaur R, Kaur H. Anaesthesia for renal transplant surgery. Acta Anaesthesiol Scand. 2007 Nov;51(10):1354-67. Review. — View Citation

Skrekas G, Papalois VE, Mitsis M, Hakim NS. Laparoscopic live donor nephrectomy: a step forward in kidney transplantation? JSLS. 2003 Jul-Sep;7(3):197-206. Review. — View Citation

Urigel S, Molter J. Transversus abdominis plane (TAP) blocks. AANA J. 2014 Feb;82(1):73-9. Review. — View Citation

Zhao X, Tong Y, Ren H, Ding XB, Wang X, Zong JY, Jin SQ, Li Q. Transversus abdominis plane block for postoperative analgesia after laparoscopic surgery: a systematic review and meta-analysis. Int J Clin Exp Med. 2014 Sep 15;7(9):2966-75. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Visual Analog Score	Visual analog scale at 2,4,6,12, and 24 hours post-operative	Day 1