Trial Outcomes & Findings for Continuous TAP Blocks: Relative Effects of a Basal Infusion vs. Repeated Bolus Doses (NCT NCT02662023)

NCT ID: NCT02662023

Last Updated: 2021-03-18

Results Overview

The distance of sensory deficit to cold measured in centimeters along the mid-axillary line. A cold roller is a device that looks like a paint application roller, but the roller itself is metal that can be brought to freezing. It is placed in the mid-axillary line and moved up and down until the sensory deficit to cold is revealed and subsequently measured.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 24 participants
• Primary outcome timeframe: 6 hours following the initiation of local anesthetic administration
• Results posted on: 2021-03-18

Participant Flow

Participant milestones

Measure	Right Side of the Body Randomized to Bolus Ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h Perineural ropivacaine administration. Since it's a split body study ,left side of the body of these participants received Ropivacaine 0.2% perineural administration as a continuous basal infusion (8 mL/h) x 6 h.	Right Side of the Body Randomized to Basal Ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) x 6 h Perineural ropivacaine administration. Since it's a split body study, left side of these participants received Ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous TAP Blocks: Relative Effects of a Basal Infusion vs. Repeated Bolus Doses

Baseline characteristics by cohort

Measure	Right Side of the Body Randomized to Bolus n=12 Participants Ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h Perineural ropivacaine administration. Since it's a split body study ,left side of the body of these participants simultaneously received Ropivacaine 0.2% perineural administration as a continuous basal infusion (8 mL/h) x 6 h.	Right Side of the Body Randomized to Basal n=12 Participants Ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) x 6 h Perineural ropivacaine administration. Since it's a split body study, left side of these participants simultenously received Ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33.2 years STANDARD_DEVIATION 14.0 • n=5 Participants	36.6 years STANDARD_DEVIATION 9.6 • n=7 Participants	35 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Height	167.9 cm STANDARD_DEVIATION 8.9 • n=5 Participants	175.7 cm STANDARD_DEVIATION 6.5 • n=7 Participants	172 cm STANDARD_DEVIATION 9 • n=5 Participants
Weight	80.0 kg STANDARD_DEVIATION 26.4 • n=5 Participants	74.9 kg STANDARD_DEVIATION 11.7 • n=7 Participants	77 kg STANDARD_DEVIATION 20 • n=5 Participants
Body Mass Index	28.3 kg/m^2 STANDARD_DEVIATION 8.9 • n=5 Participants	24.3 kg/m^2 STANDARD_DEVIATION 3.6 • n=7 Participants	26 kg/m^2 STANDARD_DEVIATION 7 • n=5 Participants

PRIMARY outcome

Timeframe: 6 hours following the initiation of local anesthetic administration

The distance of sensory deficit to cold measured in centimeters along the mid-axillary line. A cold roller is a device that looks like a paint application roller, but the roller itself is metal that can be brought to freezing. It is placed in the mid-axillary line and moved up and down until the sensory deficit to cold is revealed and subsequently measured.

Outcome measures

Measure	Bolus n=24 Participants ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h perineural ropivacaine administration	Basal n=24 Participants ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) x 6 h perineural ropivacaine administration
Sensory Deficit (Cold Roller), Mid-axillary Line	9.2 cm Standard Deviation 5.6	9.3 cm Standard Deviation 5.1

SECONDARY outcome

Timeframe: Hourly from Hours 0-5 following the initiation of local anesthetic administration

The distance of sensory deficit to cold measured in centimeters along the mid-axillary line. A cold roller is a device that looks like a paint application roller, but the roller itself is metal that can be brought to freezing. It is placed in the mid-axillary line and moved up and down until the sensory deficit to cold is revealed and subsequently measured.

Outcome measures

Measure	Bolus n=24 Participants ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h perineural ropivacaine administration	Basal n=24 Participants ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) x 6 h perineural ropivacaine administration
Sensory Deficit (Cold Roller), Mid-axillary Line Hour 0	0 cm Standard Deviation 0.3	0 cm Standard Deviation 0
Sensory Deficit (Cold Roller), Mid-axillary Line Hour 1	8.0 cm Standard Deviation 5.7	2.9 cm Standard Deviation 4.2
Sensory Deficit (Cold Roller), Mid-axillary Line Hour 2	8.6 cm Standard Deviation 5.2	7.8 cm Standard Deviation 6.4
Sensory Deficit (Cold Roller), Mid-axillary Line Hour 3	7.8 cm Standard Deviation 6.2	7.5 cm Standard Deviation 4.2
Sensory Deficit (Cold Roller), Mid-axillary Line Hour 4	9.3 cm Standard Deviation 5.7	9.0 cm Standard Deviation 6.2
Sensory Deficit (Cold Roller), Mid-axillary Line Hour 5	9.3 cm Standard Deviation 5.9	9.7 cm Standard Deviation 4.9

SECONDARY outcome

Timeframe: Hourly from Hours 0-6 following the initiation of local anesthetic administration

The distance of sensory deficit to cold measured in centimeters along the transverse horizontal line passing through the anterior superior iliac spine. A cold roller is a device that looks like a paint application roller, but the roller itself is metal that can be brought to freezing. It is placed along the line described above and moved anterior and posterior until the sensory deficit to cold is revealed and subsequently measured.

Outcome measures

Measure	Bolus n=24 Participants ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h perineural ropivacaine administration	Basal n=24 Participants ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) x 6 h perineural ropivacaine administration
Sensory Deficit (Cold Roller), Transverse Horizontal Line Hour 5	16.6 cm Standard Deviation 9.3	15.3 cm Standard Deviation 9.3
Sensory Deficit (Cold Roller), Transverse Horizontal Line Hour 6	16.8 cm Standard Deviation 9.6	15.8 cm Standard Deviation 8.1
Sensory Deficit (Cold Roller), Transverse Horizontal Line Hour 0	0 cm Standard Deviation 0	0 cm Standard Deviation 0
Sensory Deficit (Cold Roller), Transverse Horizontal Line Hour 1	11.8 cm Standard Deviation 7.6	7.7 cm Standard Deviation 10.5
Sensory Deficit (Cold Roller), Transverse Horizontal Line Hour 2	14.0 cm Standard Deviation 7.9	14.3 cm Standard Deviation 11.5
Sensory Deficit (Cold Roller), Transverse Horizontal Line Hour 3	15.6 cm Standard Deviation 10.8	14.4 cm Standard Deviation 9.0
Sensory Deficit (Cold Roller), Transverse Horizontal Line Hour 4	16.1 cm Standard Deviation 8.9	15.4 cm Standard Deviation 8.3

SECONDARY outcome

Timeframe: Hourly from Hours 0-6 following the initiation of local anesthetic administration

The distance of sensory deficit to von Frey hairs which measure sensitivity to pressure in centimeters along the transverse horizontal line passing through the anterior superior iliac spine. The von Frey hairs are pushed into the skin along the line described above and moved anterior and posterior until the sensory deficit to pressure is revealed and subsequently measured.

Outcome measures

Measure	Bolus n=24 Participants ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h perineural ropivacaine administration	Basal n=24 Participants ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) x 6 h perineural ropivacaine administration
Sensory Deficit (Von Frey Hairs), Transverse Horizontal Line Hour 0	0 cm Standard Deviation 0	0 cm Standard Deviation 0
Sensory Deficit (Von Frey Hairs), Transverse Horizontal Line Hour 1	7.6 cm Standard Deviation 6.0	6.0 cm Standard Deviation 8.4
Sensory Deficit (Von Frey Hairs), Transverse Horizontal Line Hour 2	10.7 cm Standard Deviation 8.3	12.2 cm Standard Deviation 9.3
Sensory Deficit (Von Frey Hairs), Transverse Horizontal Line Hour 3	11.9 cm Standard Deviation 8.2	14.5 cm Standard Deviation 5.7
Sensory Deficit (Von Frey Hairs), Transverse Horizontal Line Hour 4	11.3 cm Standard Deviation 8.6	11.6 cm Standard Deviation 7.4
Sensory Deficit (Von Frey Hairs), Transverse Horizontal Line Hour 5	13.6 cm Standard Deviation 10.0	13.4 cm Standard Deviation 7.7
Sensory Deficit (Von Frey Hairs), Transverse Horizontal Line Hour 6	12.8 cm Standard Deviation 10.0	13.2 cm Standard Deviation 7.8

SECONDARY outcome

Timeframe: Hourly from Hours 0-6 following the initiation of local anesthetic administration

The distance of sensory deficit to von Frey hairs which measure sensitivity to pressure in centimeters along the mid-axillary line. The von Frey hairs are pushed into the skin along the line described above and moved cephalad and caudal until the sensory deficit to pressure is revealed and subsequently measured.

Outcome measures

Measure	Bolus n=24 Participants ropivacaine 0.2% administration as repeated, scheduled (one/3 h) bolus doses (24 mL) x 6 h perineural ropivacaine administration	Basal n=24 Participants ropivacaine 0.2% administration as a continuous basal infusion (8 mL/h) x 6 h perineural ropivacaine administration
Sensory Deficit (Von Frey Hairs), Mid-axillary Line Hour 4	8.8 cm Standard Deviation 7.1	7.5 cm Standard Deviation 5.6
Sensory Deficit (Von Frey Hairs), Mid-axillary Line Hour 0	0 cm Standard Deviation 0	0 cm Standard Deviation 0
Sensory Deficit (Von Frey Hairs), Mid-axillary Line Hour 1	7.4 cm Standard Deviation 6.3	3.0 cm Standard Deviation 4.5
Sensory Deficit (Von Frey Hairs), Mid-axillary Line Hour 2	7.4 cm Standard Deviation 4.8	6.9 cm Standard Deviation 4.6
Sensory Deficit (Von Frey Hairs), Mid-axillary Line Hour 3	7.9 cm Standard Deviation 6.0	9.1 cm Standard Deviation 6.9
Sensory Deficit (Von Frey Hairs), Mid-axillary Line Hour 5	7.8 cm Standard Deviation 6.5	10.5 cm Standard Deviation 6.0
Sensory Deficit (Von Frey Hairs), Mid-axillary Line Hour 6	7.0 cm Standard Deviation 5.3	6.4 cm Standard Deviation 5.3

Adverse Events

Bolus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Basal

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

Brian M. Ilfeld, MD, MS

University of California, San Diego

Email: bilfeld@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place