TAP Block: Does Volume Make a Difference?

NCT ID: NCT01307215

Last Updated: 2013-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Post-operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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20mLs of 0.5% ropivacaine per side

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

20mLs of 0.5%

30mLs of 0.33% ropivacaine per side

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

30mLs of 0.33%

40mLs of 0.25% ropivacaine per side

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

40mLs of 0.25%

Interventions

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Ropivacaine

20mLs of 0.5%

Intervention Type DRUG

Ropivacaine

30mLs of 0.33%

Intervention Type DRUG

Ropivacaine

40mLs of 0.25%

Intervention Type DRUG

Other Intervention Names

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naropeine naropin naropeine naropin naropeine naropin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mauricio Forero, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University/St. Joseph's Healthcare

Locations

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St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 20175754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19020158 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27965789 (View on PubMed)

Other Identifiers

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10-3436

Identifier Type: -

Identifier Source: org_study_id

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