NCT01307215

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 24, 2013

Status Verified

May 1, 2011

Enrollment Period

1.8 years

First QC Date

February 28, 2011

Last Update Submit

April 23, 2013

Conditions

Post-operative Pain

Keywords

TAP blockincision paintotal hysterectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 month

Secondary Outcomes (7)

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

    48 hours

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

    48 hours

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

    48 hours

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

    48 hours

  • Block failure rate.

    48 hours

  • +2 more secondary outcomes

Study Arms (3)

20mLs of 0.5% ropivacaine per side

EXPERIMENTAL
Drug: Ropivacaine

30mLs of 0.33% ropivacaine per side

EXPERIMENTAL
Drug: Ropivacaine

40mLs of 0.25% ropivacaine per side

EXPERIMENTAL
Drug: Ropivacaine

Interventions

RopivacaineDRUG

20mLs of 0.5%

Also known as: naropeine, naropin
20mLs of 0.5% ropivacaine per side

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (3)

  • 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

  • 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: 19020158BACKGROUND

  • 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.

    PMID: 27965789DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Mauricio Forero, MD

    McMaster University/St. Joseph's Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 2, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

April 24, 2013

Record last verified: 2011-05

Locations

CA(1)