Analgesic Effect of Three-point Transversus Abdominis Plane Block Compared With Continuous Epidural Infusion for Post-laparoscopic Nephrectomy
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
May 16, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedFebruary 28, 2018
February 1, 2018
4 months
May 11, 2017
February 27, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
TAP blocks
ACTIVE COMPARATORTAP 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
ACTIVE COMPARATOREpidural group received epidural regional anesthesia in sitting position, with epidural regimen of 0.25% bupivacaine without any adjuvant
Interventions
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 was given with epidural regimen of 0.25% bupivacaine without any adjuvant
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cipto Mangunkusumo Central National Hospital
Jakarta, DKI Jakarta, 10430, Indonesia
Related Publications (10)
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.
PMID: 23150820BACKGROUNDSarinKapoor H, Kaur R, Kaur H. Anaesthesia for renal transplant surgery. Acta Anaesthesiol Scand. 2007 Nov;51(10):1354-67. doi: 10.1111/j.1399-6576.2007.01447.x.
PMID: 17944639BACKGROUNDGulyam 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.
PMID: 24974901BACKGROUNDUrigel S, Molter J. Transversus abdominis plane (TAP) blocks. AANA J. 2014 Feb;82(1):73-9.
PMID: 24654355BACKGROUNDBhosale 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.
PMID: 18555130BACKGROUNDSkrekas 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.
PMID: 14558706BACKGROUNDMinnee RC, Idu MM. Laparoscopic donor nephrectomy. Neth J Med. 2010 May;68(5):199-206.
PMID: 20508268BACKGROUNDOyen 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. No abstract available.
PMID: 18237747BACKGROUNDBiglarnia AR, Tufveson G, Lorant T, Lennmyr F, Wadstrom 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.
PMID: 21199350BACKGROUNDZhao 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.
PMID: 25356170BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiology Consultant
Study Record Dates
First Submitted
May 11, 2017
First Posted
May 16, 2017
Study Start
September 1, 2017
Primary Completion
December 31, 2017
Study Completion
January 31, 2018
Last Updated
February 28, 2018
Record last verified: 2018-02