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Transversus Abdominis Plane Catheter: a Study of Method

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Placing bilateral TAP-catheters preoperatively
Bupivacain 2.5 mg/ml with epinephrine bolus in TAP-catheters
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Transversus Abdominis Plane catheter, TAP catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • departement of anesthesiology, Aalborg University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TAP-catheter

Arm Description

Each patient receives bilateral TAP-catheters preoperatively.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Opioid Requirements Postoperative
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.

Full Information

First Posted
July 13, 2011
Last Updated
January 5, 2012
Sponsor
Aalborg University Hospital
Collaborators
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01395043
Brief Title
Transversus Abdominis Plane Catheter: a Study of Method
Official Title
TAP-catheter With Intermittent Bolus Injections of Bupivacain, an Alternative to Epidural Catheter Infusion After Colon Surgery?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Transversus Abdominis Plane catheter, TAP catheter

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP-catheter
Arm Type
Other
Arm Description
Each patient receives bilateral TAP-catheters preoperatively.
Intervention Type
Procedure
Intervention Name(s)
Placing bilateral TAP-catheters preoperatively
Other Intervention Name(s)
Bilateral TAP-catheter
Intervention Description
Place bilateral TAP-catheters preoperatively and give repeated boluses of local analgetics in order to treat postoperative pain after colon-surgery.
Intervention Type
Drug
Intervention Name(s)
Bupivacain 2.5 mg/ml with epinephrine bolus in TAP-catheters
Intervention Description
Intermittent boluses of Bupivacain 2.5 mg/ml with epinephrine, 20 ml in each catheter every 12 hours for the first 2 postoperative days.
Primary Outcome Measure Information:
Title
Postoperative Pain Using Numerical Rating Scale (NRS) 0-10
Description
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.
Time Frame
0-36 hours postoperative
Secondary Outcome Measure Information:
Title
Opioid Requirements Postoperative
Description
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.
Time Frame
48 hours from arriving in the post anesthesia care unit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bodil Rasmussen, PhD
Organizational Affiliation
departement of anesthesiology, Aalborg Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
departement of anesthesiology, Aalborg University Hospital
City
Aalborg
State/Province
Region Nordjylland
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

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Transversus Abdominis Plane Catheter: a Study of Method

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