Clinical trial NCT01395043: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Transversus Abdominis Plane catheter
TAP catheter
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2011-07-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Postoperative Pain Using Numerical Rating Scale (NRS) 0-10
timeFrame: 0-36 hours postoperative
Secondary outcomes:
measure: Opioid Requirements Postoperative
timeFrame: 48 hours from arriving in the post anesthesia care unit.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: departement of anesthesiology, Aalborg University Hospital
state: Region Nordjylland
Study officials:
affiliation: departement of anesthesiology, Aalborg Hospital
name: Bodil Rasmussen, PhD
role: STUDY_CHAIR
References: