Transversus Abdominis Plane Catheter: a Study of Method

NCT ID: NCT01395043

Last Updated: 2012-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-06-30

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

TAP-catheter

Each patient receives bilateral TAP-catheters preoperatively.

Group Type: OTHER

Placing bilateral TAP-catheters preoperatively

Intervention Type: PROCEDURE

Place bilateral TAP-catheters preoperatively and give repeated boluses of local analgetics in order to treat postoperative pain after colon-surgery.

Bupivacain 2.5 mg/ml with epinephrine bolus in TAP-catheters

Intervention Type: DRUG

Intermittent boluses of Bupivacain 2.5 mg/ml with epinephrine, 20 ml in each catheter every 12 hours for the first 2 postoperative days.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

Bilateral TAP-catheter

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nils Bjerregaard

Departement of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bodil Rasmussen, PhD

Role: STUDY_CHAIR

departement of anesthesiology, Aalborg Hospital

Locations

departement of anesthesiology, Aalborg University Hospital

Aalborg, North Denmark, Denmark

Countries

Denmark

Other Identifiers

N-20100001

Identifier Type: -

Identifier Source: org_study_id