Trial Outcomes & Findings for Ultrasound-guided Transversus Abdominis Plane Block After Hysterectomy (NCT NCT01153503)

Results Overview

Morphine consumption over the first 24 hours

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

24 hours post surgery

Results posted on

2018-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Ketorolac 30 mg, IV + TAP Block Bilateral ultrasound-guided TAP blocks and Ketorolac 30 mg IV at the end of the surgery First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h and IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn	TAP Block Bilateral ultrasound-guided TAP block at the end of the surgery First 24-h Postoperative: IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn	Ketorolac 30 mg Ketorolac 30 mg, IV at the end of surgery First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn
Overall Study STARTED	25	25	25
Overall Study COMPLETED	25	24	25
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound-guided Transversus Abdominis Plane Block After Hysterectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketorolac 30 mg, IV + TAP Block n=25 Participants Bilateral ultrasound-guided TAP block at the end of the surgery First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine	TAP Block n=24 Participants Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine First 24-h postoperative: IV-PCA morphine	Ketorolac 30 mg IV n=25 Participants Ketorolac 30 mg, IV at the end of surgery First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine	Total n=74 Participants Total of all reporting groups
Age, Continuous	42.4 years STANDARD_DEVIATION 5.4 • n=5 Participants	43.8 years STANDARD_DEVIATION 6.5 • n=7 Participants	43.1 years STANDARD_DEVIATION 5.6 • n=5 Participants	43.1 years STANDARD_DEVIATION 5.8 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	24 Participants n=7 Participants	25 Participants n=5 Participants	74 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	25 participants n=5 Participants	24 participants n=7 Participants	25 participants n=5 Participants	74 participants n=4 Participants

PRIMARY outcome

Timeframe: 24 hours post surgery

Morphine consumption over the first 24 hours

Outcome measures

Outcome measures
Measure	Ketorolac 30 mg, IV + TAP Block n=25 Participants Bilateral ultrasound-guided TAP block at the end of the surgery First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine	TAP Block n=24 Participants Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine First 24-h postoperative: IV-PCA morphine	Ketorolac 30 mg n=25 Participants Ketorolac 30 mg after surgery First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine
Morphine Consumption	38.4 mg Standard Deviation 25.7	38.6 mg Standard Deviation 26.8	42.6 mg Standard Deviation 31.2

Adverse Events

Ketorolac 30 mg, IV + TAP Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TAP Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ketorolac 30 mg

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

Irina Gasanova, MD, PhD

University of Texas Southwestern Medical Center

Phone: 214-590-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place