Transversus Abdominis Plane Catheter: a Study of Method
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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? |
- 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.
- 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 |
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| Denmark | |
| departement of anesthesiology, Aalborg University Hospital | |
| Aalborg, Region Nordjylland, Denmark, 9000 | |
| 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 May 23, 2013