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 Universitetshospital:

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
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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 Universitetshospital
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 Universitetshospital:
Transversus Abdominis Plane catheter
TAP catheter

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

ClinicalTrials.gov processed this record on October 22, 2014