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Transversus Abdominis Plane Catheter: a Study of Method

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ClinicalTrials.gov Identifier: NCT01395043
Recruitment Status : Completed
First Posted : July 15, 2011
Results First Posted : February 7, 2012
Last Update Posted : February 7, 2012
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Nils Bjerregaard, Aalborg University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Placing bilateral TAP-catheters preoperatively Drug: Bupivacain 2.5 mg/ml with epinephrine bolus in TAP-catheters Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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?
Study Start Date : September 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative Pain Using Numerical Rating Scale (NRS) 0-10 [ Time Frame: 0-36 hours postoperative ]

    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 :
  1. Opioid Requirements Postoperative [ Time Frame: 48 hours from arriving in the post anesthesia care unit. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395043


Locations
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Denmark
departement of anesthesiology, Aalborg University Hospital
Aalborg, Region Nordjylland, Denmark, 9000
Sponsors and Collaborators
Aalborg University Hospital
University of Aarhus
Investigators
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Study Chair: Bodil Rasmussen, PhD departement of anesthesiology, Aalborg Hospital
More Information
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Responsible Party: Nils Bjerregaard, Departement of anesthesia, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT01395043    
Other Study ID Numbers: N-20100001
First Posted: July 15, 2011    Key Record Dates
Results First Posted: February 7, 2012
Last Update Posted: February 7, 2012
Last Verified: January 2012
Keywords provided by Nils Bjerregaard, Aalborg University Hospital:
Transversus Abdominis Plane catheter
TAP catheter
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Epinephrine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
 Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents