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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP-catheter | Other | Each patient receives bilateral TAP-catheters preoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placing bilateral TAP-catheters preoperatively | Procedure | Place bilateral TAP-catheters preoperatively and give repeated boluses of local analgetics in order to treat postoperative pain after colon-surgery. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bodil Rasmussen, PhD | departement of anesthesiology, Aalborg Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| departement of anesthesiology, Aalborg University Hospital | Aalborg | North Denmark | 9000 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bilateral Ultrasoundguide TAP-catheter | All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bilateral Ultrasoundguide TAP-catheter | All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | mg iv morphin equivalent | 48 hours from arriving in the post anesthesia care unit. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bilateral Ultrasoundguide TAP-catheter | All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters |
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Not randomised or blinded. Limited number of patients. Dermatome level of the block and the incidence of postoperative nausea and vomiting was not registered. The study does not compare TAP-catheter and epidural catheter.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nils Bjerregaard | Aalborg Hospital | 004522860649 | niheb@rn.dk |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| Bupivacain 2.5 mg/ml with epinephrine bolus in TAP-catheters | 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. |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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. | Posted | Median | Inter-Quartile Range | Units on Numerical Rating Score | 0-36 hours postoperative |
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| 0 |
| 15 |
| 0 |
| 15 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |