Trial Outcomes & Findings for Transversus Abdominis Plane (TAP) Block for Cesarean Section (NCT NCT01015807)

Results Overview

Determine which of three different TAP formulations (Placebo, TAP, Clo-TAP) has the most beneficial effect on the postoperative area of hyperalgesia 48hrs after the start of the cesarean section. The smaller the area of WHA, assessed in cm2, the better the outcome. Area sizes may range from 0 to any size.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

48hrs after CS

Results posted on

2017-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo Bupivacaine Placebo: 2 x 20mL 0.9% NaCl Clonidine Placebo: 2 x 1mL 0.9% NaCl	TAP (Bupi) 2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo Clonidine Placebo: 2 x 1mL 0.9% NaCl Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine	Clo-TAP (Bupi + Clon) 2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine
Overall Study STARTED	30	30	30
Overall Study COMPLETED	30	30	30
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transversus Abdominis Plane (TAP) Block for Cesarean Section

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=30 Participants Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo Bupivacaine Placebo: 2 x 20mL 0.9% NaCl Clonidine Placebo: 2 x 1mL 0.9% NaCl	TAP (Bupi) n=30 Participants 2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo Clonidine Placebo: 2 x 1mL 0.9% NaCl Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine	Clo-TAP (Bupi + Clon) n=30 Participants 2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine	Total n=90 Participants Total of all reporting groups
Age, Continuous	30.5 years STANDARD_DEVIATION 6.7 • n=5 Participants	31.8 years STANDARD_DEVIATION 4.5 • n=7 Participants	29.5 years STANDARD_DEVIATION 6.7 • n=5 Participants	30 years STANDARD_DEVIATION 5.5 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	30 Participants n=5 Participants	90 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

PRIMARY outcome

Timeframe: 48hrs after CS

Determine which of three different TAP formulations (Placebo, TAP, Clo-TAP) has the most beneficial effect on the postoperative area of hyperalgesia 48hrs after the start of the cesarean section. The smaller the area of WHA, assessed in cm2, the better the outcome. Area sizes may range from 0 to any size.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo Bupivacaine Placebo: 2 x 20mL 0.9% NaCl Clonidine Placebo: 2 x 1mL 0.9% NaCl	TAP (Bupi) n=30 Participants 2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo Clonidine Placebo: 2 x 1mL 0.9% NaCl Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine	Clo-TAP (Bupi + Clon) n=30 Participants 2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine
Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups	1.07 cm^2 Interval 0.48 to 3.26	1.27 cm^2 Interval 0.59 to 2.95	0.74 cm^2 Interval 0.09 to 2.25

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TAP (Bupi)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clo-TAP (Bupi + Clon)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=30 participants at risk Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo Bupivacaine Placebo: 2 x 20mL 0.9% NaCl Clonidine Placebo: 2 x 1mL 0.9% NaCl	TAP (Bupi) n=30 participants at risk 2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo Clonidine Placebo: 2 x 1mL 0.9% NaCl Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine	Clo-TAP (Bupi + Clon) n=30 participants at risk 2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine
Cardiac disorders LAST	0.00% 0/30 • 1 year	0.00% 0/30 • 1 year	0.00% 0/30 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Dr. Laurent Bollag

Univerisity of Washington

Phone: +12063277328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place