Trial Outcomes & Findings for Transversus Abdominis Plane Catheter: a Study of Method (NCT NCT01395043)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

0-36 hours postoperative

Results posted on

2012-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transversus Abdominis Plane Catheter: a Study of Method

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bilateral Ultrasoundguide TAP-catheter n=15 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age Continuous	66 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Denmark	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bilateral Ultrasoundguide TAP-catheter n=15 Participants 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
Postoperative Pain Using Numerical Rating Scale (NRS) 0-10 NRS at rest, all times	3 Units on Numerical Rating Score Interval 2.0 to 6.0
Postoperative Pain Using Numerical Rating Scale (NRS) 0-10 Overall NRS when coughing, all times	5 Units on Numerical Rating Score Interval 2.0 to 6.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bilateral Ultrasoundguide TAP-catheter n=15 Participants 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
Opioid Requirements Postoperative	35 mg iv morphin equivalent Interval 22.0 to 39.0

Adverse Events

Bilateral Ultrasoundguide TAP-catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Nils Bjerregaard

Aalborg Hospital

Phone: 004522860649

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place