NCT01871168

Brief Summary

The purpose of this study is to establish an alternative method of postoperative pain control to the current standard of practice, patient-controlled analgesia with intravenous opioids, for patients undergoing a major major abdominal surgery at the University of Alberta Hospital. The primary objective is to determine whether a continuous transversus abdominis plane (TAP) block, run until the third postoperative day, will reduce the amount of intravenous morphine required. Additionally, the investigators propose to measure the amount of local anesthetic (lidocaine) in the blood during this time frame to provide patient safety data for this procedure. This will be a prospective controlled randomized double-blind clinical trial. The patients, anesthesiologists and staff providing post operative care will be blinded to group assignment. Patients will be randomized by sealed envelopes.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

3.5 years

First QC Date

June 3, 2013

Last Update Submit

March 23, 2020

Conditions

Nerve BlockPain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Morphine requirements following major abdominal surgery

    Morphine consumption will be measured every 24 hours following surgery.

    96 hours post-surgery

Secondary Outcomes (4)

  • Pain

    96 hours post-surgery

  • Sedation

    96 hours post-surgery

  • Nausea

    96 hours post-surgery

  • Systemic effects of lidocaine

    72 hours post-surgery

Study Arms (2)

Sham TAP block

SHAM COMPARATOR

Patients receive TAP catheters but saline infusion instead of local anesthetic

Procedure: Sham TAP block

TAP block

EXPERIMENTAL

Patients receive a continuous TAP block

Procedure: TAP block

Interventions

TAP blockPROCEDURE

Infusion of 0.5-1% lidocaine

TAP block
Sham TAP blockPROCEDURE

Infusion of saline

Sham TAP block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing major abdominal surgery who consent to a continuous transversus abdominis nerve block as part of their postoperative management

You may not qualify if:

  • History of allergy to local anesthesia
  • Infection in the area of intended catheter insertion
  • Opiate tolerance
  • Failure to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2G3, Canada

Location

Related Publications (5)

  • 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.

    PMID: 20175754BACKGROUND

  • 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.

    PMID: 17179269BACKGROUND

  • Hebbard P. Subcostal transversus abdominis plane block under ultrasound guidance. Anesth Analg. 2008 Feb;106(2):674-5; author reply 675. doi: 10.1213/ane.0b013e318161a88f. No abstract available.

    PMID: 18227342BACKGROUND

  • Kato N, Fujiwara Y, Harato M, Kurokawa S, Shibata Y, Harada J, Komatsu T. Serum concentration of lidocaine after transversus abdominis plane block. J Anesth. 2009;23(2):298-300. doi: 10.1007/s00540-008-0721-4. Epub 2009 May 15.

    PMID: 19444577BACKGROUND

  • Griffiths JD, Barron FA, Grant S, Bjorksten AR, Hebbard P, Royse CF. Plasma ropivacaine concentrations after ultrasound-guided transversus abdominis plane block. Br J Anaesth. 2010 Dec;105(6):853-6. doi: 10.1093/bja/aeq255. Epub 2010 Sep 22.

    PMID: 20861094BACKGROUND

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 6, 2013

Study Start

May 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2017

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

CA(1)