Transversus Abdominis Plane Catheter: a Study of Method
|ClinicalTrials.gov Identifier: NCT01395043|
Recruitment Status : Completed
First Posted : July 15, 2011
Results First Posted : February 7, 2012
Last Update Posted : February 7, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Procedure: Placing bilateral TAP-catheters preoperatively Drug: Bupivacain 2.5 mg/ml with epinephrine bolus in TAP-catheters||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||TAP-catheter With Intermittent Bolus Injections of Bupivacain, an Alternative to Epidural Catheter Infusion After Colon Surgery?|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
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 Name: 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.
- Postoperative Pain Using Numerical Rating Scale (NRS) 0-10 [ Time Frame: 0-36 hours postoperative ]
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.
- Opioid Requirements Postoperative [ Time Frame: 48 hours from arriving in the post anesthesia care unit. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395043
|departement of anesthesiology, Aalborg University Hospital|
|Aalborg, Region Nordjylland, Denmark, 9000|
|Study Chair:||Bodil Rasmussen, PhD||departement of anesthesiology, Aalborg Hospital|