Transversus Abdominis Plane Catheter: a Study of Method

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Placing bilateral TAP-catheters preoperatively; Drug: Bupivacain 2.5 mg/ml with epinephrine bolus in TAP-catheters

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region Nordjylland
    • Aalborg, Region Nordjylland, Denmark, 9000
      • departement of anesthesiology, Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: University of Aarhus
• Investigators: Study Chair: Bodil Rasmussen, PhD, departement of anesthesiology, Aalborg Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 13, 2011
• First Submitted That Met QC Criteria: July 14, 2011
• First Posted (Estimate): July 15, 2011

Study Record Updates

• Last Update Posted (Estimate): February 7, 2012
• Last Update Submitted That Met QC Criteria: January 5, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Transversus Abdominis Plane catheter; TAP catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: N-20100001