Transversus Abdominis Plane Catheter: a Study of Method

This study has been completed.
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Nils Bjerregaard, Aalborg Hospital
ClinicalTrials.gov Identifier:
NCT01395043
First received: July 13, 2011
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Postoperative Pain
Procedure: Placing bilateral TAP-catheters preoperatively
Drug: Bupivacain 2.5 mg/ml with epinephrine bolus in TAP-catheters

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: TAP-catheter With Intermittent Bolus Injections of Bupivacain, an Alternative to Epidural Catheter Infusion After Colon Surgery?

Resource links provided by NLM:


Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • Postoperative Pain Using Numerical Rating Scale (NRS) 0-10 [ Time Frame: 0-36 hours postoperative ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Opioid Requirements Postoperative [ Time Frame: 48 hours from arriving in the post anesthesia care unit. ] [ Designated as safety issue: No ]
    Supplementary opioid requirements for the first 48 hours from arriving in the post anesthesia care unit. Results are total opioid-requirements for the first 48 hours. Way of administration was intravenous in all but 6 administrations. If given orally, a 1:3 ratio was used for conversion from oral to intravenous morphine.


Enrollment: 15
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TAP-catheter
Each patient receives bilateral TAP-catheters preoperatively.
Procedure: Placing bilateral TAP-catheters preoperatively
Place bilateral TAP-catheters preoperatively and give repeated boluses of local analgetics in order to treat postoperative pain after colon-surgery.
Other Name: Bilateral TAP-catheter
Drug: Bupivacain 2.5 mg/ml with epinephrine bolus in TAP-catheters
Intermittent boluses of Bupivacain 2.5 mg/ml with epinephrine, 20 ml in each catheter every 12 hours for the first 2 postoperative days.

Detailed Description:

Postoperative pain is a major challenge in the work of anesthesia. Epidural catheter is the golden standard for postoperative pain management after major abdominal surgery. However a number of patient have absolute or relative contraindication to the placement of an epidural catheter. It is therefore necessary to find a good alternative to epidural catheter.

Transversus abdominis plane(TAP) block has been shown to provide analgesia of the abdominal wall and reduce opioid-requirements and pain after abdominal surgery.

However the effect of a TAP block is limited to the time of efficacy of the local analgesic used. Placing a TAP-catheter in order to prolong the effect of the TAP-block by repeatedly bolus-injections in the TAP-catheters has only been sporadically described and so far never investigated in a systematic way.

We will investigate the practical and technical possibility to place bilateral ultrasound-guided TAP-catheters pre-operatively on patients undergoing elective colon-resection. Further more we will evaluate the pain and opioid-requirement postoperatively.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • re-operation within the first 48 hours
  • need for sedation and ventilator-support postoperatively
  • accidental removal of catheter within the first 24 hours
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395043

Locations
Denmark
departement of anesthesiology, Aalborg University Hospital
Aalborg, Region Nordjylland, Denmark, 9000
Sponsors and Collaborators
Aalborg Universityhospital
University of Aarhus
Investigators
Study Chair: Bodil Rasmussen, PhD departement of anesthesiology, Aalborg Hospital
  More Information

No publications provided

Responsible Party: Nils Bjerregaard, Departement of anesthesia, Aalborg Hospital
ClinicalTrials.gov Identifier: NCT01395043     History of Changes
Other Study ID Numbers: N-20100001
Study First Received: July 13, 2011
Results First Received: October 6, 2011
Last Updated: January 5, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Aalborg Universityhospital:
Transversus Abdominis Plane catheter
TAP catheter

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Epinephrine
Epinephryl borate
Bupivacaine
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents

ClinicalTrials.gov processed this record on April 17, 2014