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TAP Block: Does Volume Make a Difference?

Primary Purpose

Post-operative Pain

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Ropivacaine

Ropivacaine

Ropivacaine

Sponsored by

McMaster University

About this trial

This is an interventional supportive care trial for Post-operative Pain focused on measuring TAP block, incision pain, total hysterectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

18-70 years old
total abdominal hysterectomy
capable of completing informed consent
no previous chronic opioid use
no previous abdominal wall surgeries

Exclusion Criteria:

patient refusal
contraindication to regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders,
local or systemic infection
local anesthetic allergy
BMI>35

Sites / Locations

St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

20mLs of 0.5% ropivacaine per side

30mLs of 0.33% ropivacaine per side

40mLs of 0.25% ropivacaine per side

Arm Description

Outcomes

Primary Outcome Measures

To assess the feasibility of a large scale clinical study to determine the influence on increasing the local anesthetic volume.

This will be shown as a number and a percenttage of patients recruited and randomized.

Secondary Outcome Measures

Using ice and pinprick, determine the dermatomal block distribution at 2,6,12,24 and 48 hours post block.

The assessor will measure the extend of the block distribution at the various time intervals.

Pain scores at 2,6,12,24, and 48 hours post-block.

Using a visual analog scale, patient pain scores will be assessed.

Patient-controlled analgesia opioid requirements at 2,6,12,24 and 48 post-block.

Record drug consumption at the time intervals

Incidence of post-operative nausea and vomiting at 2,6,12,24, and 48 hours.

Block failure rate.

Block failure rate is defined as the lack of any sensory block following the TAP block.

Patient's overall satisfaction.

Using a LIKERT score, patient satisfaction will be measured.

Discharge time from PACU.

The time in which the patient is discharged from the recovery room.

Full Information

NCT ID

First Posted

February 28, 2011

Last Updated

April 23, 2013

Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton

1. Study Identification

Unique Protocol Identification Number

NCT01307215

Brief Title

TAP Block: Does Volume Make a Difference?

Official Title

Lumbar Transversus Abdominal Plane (TAP) Block: Does Volume Make a Difference?

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

Patients who have abdominal surgery will experience pain from the incision. The lumbar TAP block is a procedure used to reach the nerve endings in the abdominal wall so that there is a reduction in pain after surgery. Using ultrasound guidance, a solution of ropivacaine will be injected after surgery. The aim of this study is to determine the effect of changes in the volume of the injection.

Detailed Description

Pain from a surgical incision happens in most patients. During the perioperative period, the use of the TAP block has been shown to reduce pain scores, opioid consumption and sedation scores. Also, there is a trend towards a reduction of post-operative nausea and vomiting. The aim of the block is to reach the distal nerve endings of the abdominal wall from T6 to L1 dermatomes using ultrasound guidance with a single shot of ropivacaine at different volumes. Currently, there is consensus about optimal procedure-specific volumes and local anesthetic concentrations for lumbar TAP blocks. This is a pilot study and the purpose being is it feasible to do a large scale clinical study to determine the influence of increasing the local anesthetic volume.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-operative Pain

Keywords

TAP block, incision pain, total hysterectomy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

20mLs of 0.5% ropivacaine per side

Arm Type

Experimental

Arm Title

30mLs of 0.33% ropivacaine per side

Arm Type

Experimental

Arm Title

40mLs of 0.25% ropivacaine per side

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Ropivacaine

Other Intervention Name(s)

naropeine, naropin

Intervention Description

20mLs of 0.5%

Intervention Type

Drug

Intervention Name(s)

Ropivacaine

Other Intervention Name(s)

naropeine, naropin

Intervention Description

30mLs of 0.33%

Intervention Type

Drug

Intervention Name(s)

Ropivacaine

Other Intervention Name(s)

naropeine, naropin

Intervention Description

40mLs of 0.25%

Primary Outcome Measure Information:

Title

To assess the feasibility of a large scale clinical study to determine the influence on increasing the local anesthetic volume.

Description

This will be shown as a number and a percenttage of patients recruited and randomized.

Time Frame

6 month

Secondary Outcome Measure Information:

Title

Using ice and pinprick, determine the dermatomal block distribution at 2,6,12,24 and 48 hours post block.

Description

The assessor will measure the extend of the block distribution at the various time intervals.

Time Frame

48 hours

Title

Pain scores at 2,6,12,24, and 48 hours post-block.

Description

Using a visual analog scale, patient pain scores will be assessed.

Time Frame

48 hours

Title

Patient-controlled analgesia opioid requirements at 2,6,12,24 and 48 post-block.

Description

Record drug consumption at the time intervals

Time Frame

48 hours

Title

Incidence of post-operative nausea and vomiting at 2,6,12,24, and 48 hours.

Time Frame

48 hours

Title

Block failure rate.

Description

Block failure rate is defined as the lack of any sensory block following the TAP block.

Time Frame

48 hours

Title

Patient's overall satisfaction.

Description

Using a LIKERT score, patient satisfaction will be measured.

Time Frame

48 hours

Title

Discharge time from PACU.

Description

The time in which the patient is discharged from the recovery room.

Time Frame

24 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 18-70 years old total abdominal hysterectomy capable of completing informed consent no previous chronic opioid use no previous abdominal wall surgeries Exclusion Criteria: patient refusal contraindication to regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders, local or systemic infection local anesthetic allergy BMI>35

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mauricio Forero, MD

Organizational Affiliation

McMaster University/St. Joseph's Healthcare

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Joseph's Healthcare Hamilton

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

20175754

Citation

Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.

Results Reference

background

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

27965789

Citation

Forero M, Heikkila A, Paul JE, Cheng J, Thabane L. Lumbar transversus abdominis plane block: the role of local anesthetic volume and concentration-a pilot, prospective, randomized, controlled trial. Pilot Feasibility Stud. 2015 Mar 25;1:10. doi: 10.1186/s40814-015-0002-6. eCollection 2015.

Results Reference

derived

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TAP Block: Does Volume Make a Difference?

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