Single-shot TAP Block vs Continuous TAP Block
TAP
Randomized, Prospective, Double Blind Study Comparing Single Shot Versus Continuous Transverses Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Live Donor Nephrectomy
1 other identifier
interventional
70
1 country
1
Brief Summary
The purpose of this study is to determine whether continuous transversus abdominis plane (TAP) block is superior to single shot TAP for postoperative pain after laparoscopic donor nephrectomy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 postoperative-pain
Started Jul 2012
Longer than P75 for phase_4 postoperative-pain
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
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
May 16, 2017
CompletedAugust 4, 2020
July 1, 2020
3.4 years
June 11, 2015
November 3, 2016
July 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Narcotic Usage at 48 Hours
The primary endpoint of this study will be narcotic requirement at 48 hours
48 hours
Secondary Outcomes (4)
Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours
up to 60 hours
Average Pain Scores
up to 60 hours
Nausea Scores at 48 Hours
up to 48 hours
Sedation Scores at 48 Hours
48 hours
Study Arms (2)
Placebo Group (TAP-S)
PLACEBO COMPARATOR(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
Active Group (TAP-C)
ACTIVE COMPARATOR(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
Interventions
TAP catheters with ropivacaine infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case.
Catheters with saline infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case.
Eligibility Criteria
You may qualify if:
- Healthy subject undergoing laparoscopic live donor nephrectomy
- (ASA) American Society of Anesthesiologists class 1 or 2
- Age 18 or older, male or female
- Desires TAP block for postoperative pain control
You may not qualify if:
- Any contraindication for TAP block - single or continuous
- History of substance abuse
- Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
- Known allergy or other contraindications to the study medications (Ropivacaine, Normal Saline, Hydromorphone, Oxycodone and Acetaminophen)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- Halyard Healthcollaborator
Study Sites (1)
Indiana University Hospital
Indianapolis, Indiana, 46202, United States
Related Publications (4)
Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
PMID: 19020158BACKGROUNDMcDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.
PMID: 18165577BACKGROUNDMcDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.
PMID: 17179269BACKGROUNDYeap YL, Wolfe JW, Kroepfl E, Fridell J, Powelson JA. Transversus abdominis plane (TAP) block for laparoscopic live donor nephrectomy: Continuous catheter infusion provides no additional analgesic benefit over single-injection ropivacaine. Clin Transplant. 2020 Jun;34(6):e13861. doi: 10.1111/ctr.13861. Epub 2020 Apr 9.
PMID: 32198963RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Yar Yeap
- Organization
- Indiana University School of Medicine - Anesthesia Division
Study Officials
- PRINCIPAL INVESTIGATOR
Yar Yeap, MD
Indiana University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Anesthesia
Study Record Dates
First Submitted
June 11, 2015
First Posted
June 18, 2015
Study Start
July 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
August 4, 2020
Results First Posted
May 16, 2017
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share