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Single-shot TAP Block vs Continuous TAP Block (TAP)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
TAP-C
TAP-S
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring transversus abdominis plane block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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)

Sites / Locations

  • Indiana University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Group (TAP-S)

Active Group (TAP-C)

Arm Description

(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

(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

Outcomes

Primary Outcome Measures

Total Narcotic Usage at 48 Hours
The primary endpoint of this study will be narcotic requirement at 48 hours

Secondary Outcome Measures

Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours
All narcotic usage will be recorded at 1,12,24,36,48, and 60 hours. All narcotics will be converted to morphine equivalent for statistical calculation. These values reflect the total amount of narcotic used after combining all the data collected from each time point.
Average Pain Scores
Post- operative VAS pain scores (range of 0-10. 0 being no pain and 10 being worst pain) will be recorded at 1,12, 24, 36,48 and 60 hours. The values at each time points were combined and averaged.
Nausea Scores at 48 Hours
Post-operative nausea scores will be recorded at 48 hours. Range of nausea score is 0-3. 0= None, 1=Mild, 2=Moderate, 3=Severe.
Sedation Scores at 48 Hours
Post-operative sedation scores will be recorded at 48 hours. Range of score is 0-3. 0=Awake and Alert, 1=Quietly Awake, 2=Asleep and Arousable, 3=Deep sleep.

Full Information

First Posted
June 11, 2015
Last Updated
July 27, 2020
Sponsor
Indiana University
Collaborators
Halyard Health
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1. Study Identification

Unique Protocol Identification Number
NCT02475031
Brief Title
Single-shot TAP Block vs Continuous TAP Block
Acronym
TAP
Official Title
Randomized, Prospective, Double Blind Study Comparing Single Shot Versus Continuous Transverses Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Live Donor Nephrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Halyard Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
This study is a randomized, prospective, double blind study comparing single shot versus continuous transversus abdominis plane (TAP) block for postoperative analgesia after laparoscopic live donor nephrectomy. Good pain control after surgery has been shown to decrease complications. To address the problem of postoperative pain control in donor nephrectomy patients,the study investigators began performing Transversus Abdominis Plane (TAP) blocks. The TAP block involves injection of local anesthetic between the abdominal muscle planes (internal oblique muscle and transversus abdominis muscle), to block the somatic nerves that supply sensation to the skin, muscles, and parietal peritoneum of the anterior abdominal wall. Prior reports of TAP blocks have shown that it provides good analgesia for postoperative pain after abdominal surgery. However because the duration of postoperative pain exceeds that of the single shot TAP block, the investigators hypothesized that by placing a catheter through which a continuous infusion of local anesthetic could be delivered, investigators could provide analgesia throughout the postoperative period. The study investigators also hypothesized that improved analgesia would decrease the need for opioid pain medications, hence decreasing the side effects associated with opioid use. This study is designed to test our hypothesis that placing a TAP catheter is superior to single shot TAP, because it provides a longer duration of analgesia and decreases narcotic use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
transversus abdominis plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Group (TAP-S)
Arm Type
Placebo Comparator
Arm Description
(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
Arm Title
Active Group (TAP-C)
Arm Type
Active Comparator
Arm Description
(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
Intervention Type
Device
Intervention Name(s)
TAP-C
Other Intervention Name(s)
Continuous TAP catheter
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
TAP-S
Other Intervention Name(s)
Single shot TAP block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Narcotic Usage at 48 Hours
Description
The primary endpoint of this study will be narcotic requirement at 48 hours
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours
Description
All narcotic usage will be recorded at 1,12,24,36,48, and 60 hours. All narcotics will be converted to morphine equivalent for statistical calculation. These values reflect the total amount of narcotic used after combining all the data collected from each time point.
Time Frame
up to 60 hours
Title
Average Pain Scores
Description
Post- operative VAS pain scores (range of 0-10. 0 being no pain and 10 being worst pain) will be recorded at 1,12, 24, 36,48 and 60 hours. The values at each time points were combined and averaged.
Time Frame
up to 60 hours
Title
Nausea Scores at 48 Hours
Description
Post-operative nausea scores will be recorded at 48 hours. Range of nausea score is 0-3. 0= None, 1=Mild, 2=Moderate, 3=Severe.
Time Frame
up to 48 hours
Title
Sedation Scores at 48 Hours
Description
Post-operative sedation scores will be recorded at 48 hours. Range of score is 0-3. 0=Awake and Alert, 1=Quietly Awake, 2=Asleep and Arousable, 3=Deep sleep.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yar Yeap, MD
Organizational Affiliation
Indiana University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19020158
Citation
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.
Results Reference
background
PubMed Identifier
18165577
Citation
McDonnell 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.
Results Reference
background
PubMed Identifier
17179269
Citation
McDonnell 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. Erratum In: Anesth Analg. 2007 May;104(5):1108.
Results Reference
background
PubMed Identifier
32198963
Citation
Yeap 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.
Results Reference
result

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Single-shot TAP Block vs Continuous TAP Block

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