NCT01395043

Brief Summary

Major abdominal surgery is associated with postoperative pain. Transversus Abdominis Plane(TAP) block has been shown to reduce pain and opioid-requirements after abdominal surgery. However a single block has a short effect of up to 12 hours depending on the type local-anesthetics used. With this study we wish to investigate the possibilities to place a TAP-catheter in order to prolong the the effect of the TAP-block by giving repeatedly bolus-injections in the TAP catheter and to study the pain and the opioid requirements of patients undergoing elective colon-resection when given a TAP-catheter preoperatively. Our hypothesis is that it is practical and technical possible to place bilateral TAP-catheters pre-operatively and that pain and opioid-requirements will be low.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2010

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

Study Start

First participant enrolled

September 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 7, 2012

Completed
Last Updated

February 7, 2012

Status Verified

January 1, 2012

Enrollment Period

9 months

First QC Date

July 13, 2011

Results QC Date

October 6, 2011

Last Update Submit

January 5, 2012

Conditions

Postoperative Pain

Keywords

Transversus Abdominis Plane catheterTAP catheter

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Using Numerical Rating Scale (NRS) 0-10

    NRS is a pain score and the score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain. NRS was evaluated at the time 0, 1, 2, 4, 8 , 12, 18 , 24 and 36 hours after arriving in the post anesthesia care unit at rest and during coughing.

    0-36 hours postoperative

Secondary Outcomes (1)

  • Opioid Requirements Postoperative

    48 hours from arriving in the post anesthesia care unit.

Study Arms (1)

TAP-catheter

OTHER

Each patient receives bilateral TAP-catheters preoperatively.

Procedure: Placing bilateral TAP-catheters preoperativelyDrug: Bupivacain 2.5 mg/ml with epinephrine bolus in TAP-catheters

Interventions

Placing bilateral TAP-catheters preoperativelyPROCEDURE

Place bilateral TAP-catheters preoperatively and give repeated boluses of local analgetics in order to treat postoperative pain after colon-surgery.

Also known as: Bilateral TAP-catheter
TAP-catheter
Bupivacain 2.5 mg/ml with epinephrine bolus in TAP-cathetersDRUG

Intermittent boluses of Bupivacain 2.5 mg/ml with epinephrine, 20 ml in each catheter every 12 hours for the first 2 postoperative days.

TAP-catheter

Eligibility Criteria

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

You may qualify if:

  • elective open colon-resection
  • adult
  • written and informed consent

You may not qualify if:

  • re-operation within the first 48 hours
  • need for sedation and ventilator-support postoperatively
  • accidental removal of catheter within the first 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

departement of anesthesiology, Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Limitations and Caveats

Not randomised or blinded. Limited number of patients. Dermatome level of the block and the incidence of postoperative nausea and vomiting was not registered. The study does not compare TAP-catheter and epidural catheter.

Results Point of Contact

Title
Dr Nils Bjerregaard
Organization
Aalborg Hospital
niheb@rn.dk
004522860649

Study Officials

  • Bodil Rasmussen, PhD

    departement of anesthesiology, Aalborg Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Departement of anesthesia

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 15, 2011

Study Start

September 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

February 7, 2012

Results First Posted

February 7, 2012

Record last verified: 2012-01

Locations

DK(1)