Transversus Abdominis Plane Catheter: a Study of Method

Postoperative Pain Clinical Trial

Official title:

TAP-catheter With Intermittent Bolus Injections of Bupivacain, an Alternative to Epidural Catheter Infusion After Colon Surgery?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395043
• Other study ID #: N-20100001
• Status: Completed
• Phase: N/A
• First received: July 13, 2011
• Last updated: January 5, 2012
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2012
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.

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.

Locations

Country	Name	City	State
Denmark	departement of anesthesiology, Aalborg University Hospital	Aalborg	Region Nordjylland

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg Universitetshospital	University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-36 hours postoperative	No
Secondary	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.	48 hours from arriving in the post anesthesia care unit.	No