NCT03154463

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

May 11, 2017

Last Update Submit

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 COMPARATOR

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

continuous epidural infusion

ACTIVE COMPARATOR

Epidural group received epidural regional anesthesia in sitting position, with epidural regimen of 0.25% bupivacaine without any adjuvant

Procedure: continuous epidural infusion

Interventions

TAP BlocksPROCEDURE

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)

TAP blocks

Continuous epidural infusion was given with epidural regimen of 0.25% bupivacaine without any adjuvant

continuous epidural infusion

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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: 23150820BACKGROUND
  • SarinKapoor 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: 17944639BACKGROUND
  • 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.

    PMID: 24974901BACKGROUND
  • Urigel S, Molter J. Transversus abdominis plane (TAP) blocks. AANA J. 2014 Feb;82(1):73-9.

    PMID: 24654355BACKGROUND
  • 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.

    PMID: 18555130BACKGROUND
  • 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.

    PMID: 14558706BACKGROUND
  • Minnee RC, Idu MM. Laparoscopic donor nephrectomy. Neth J Med. 2010 May;68(5):199-206.

    PMID: 20508268BACKGROUND
  • 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. No abstract available.

    PMID: 18237747BACKGROUND
  • Biglarnia 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: 21199350BACKGROUND
  • 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.

    PMID: 25356170BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

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

Locations