Trial Outcomes & Findings for Ultrasound Guided Supraclavicular Nerve Block (NCT NCT00825786)

NCT ID: NCT00825786

Last Updated: 2017-06-14

Results Overview

The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 103 participants
• Primary outcome timeframe: During surgery: postoperative day 0
• Results posted on: 2017-06-14

Participant Flow

Participant milestones

Measure	Treatment combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	Control sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Overall Study STARTED	52	51
Overall Study COMPLETED	52	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound Guided Supraclavicular Nerve Block

Baseline characteristics by cohort

Measure	Group 1 n=52 Participants combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	Group 2 n=51 Participants sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	Total n=103 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 13 • n=5 Participants	46 years STANDARD_DEVIATION 14 • n=7 Participants	47 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	32 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	19 Participants n=7 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: During surgery: postoperative day 0

The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.

Outcome measures

Measure	Group 1 n=52 Participants combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	Group 2 n=51 Participants sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Duration of Analgesia.	7.5 minute Interval 4.0 to 14.0	10 minute Interval 7.0 to 20.0

SECONDARY outcome

Timeframe: during surgery from induction time to end case time

Outcome measures

Measure	Group 1 n=52 Participants combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	Group 2 n=51 Participants sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Time to Complete Motor Block	10 minutes Interval 5.0 to 18.0	19 minutes Interval 8.0 to 29.0

SECONDARY outcome

Timeframe: during surgery

Outcome measures

Measure	Group 1 n=52 Participants combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	Group 2 n=51 Participants sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Time to Onset of First Sensory Block	0 minutes Interval 0.0 to 0.0	0 minutes Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: through post operative day 3

The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10= worst pain

Outcome measures

Measure	Group 1 n=52 Participants combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	Group 2 n=51 Participants sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Maximum Verbal Response Score (VRS) With Rest	4 mm Interval 2.0 to 7.0	4 mm Interval 1.0 to 6.0

SECONDARY outcome

Timeframe: through post operative day 3

The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10 = worst

Outcome measures

Measure	Group 1 n=52 Participants combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	Group 2 n=51 Participants sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Maximum Verbal Response Score (VRS) With Movement	5.5 mm Interval 3.5 to 8.0	5 mm Interval 2.0 to 7.0

SECONDARY outcome

Timeframe: from surgery date to postoperative day 1

Time from the complete onset of sensory block until first request for an analgesic

Outcome measures

Measure	Group 1 n=52 Participants combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	Group 2 n=51 Participants sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Duration of Analgesia	9 hours Interval 6.0 to 22.0	11 hours Interval 7.0 to 20.0

SECONDARY outcome

Timeframe: postoperative day 1 to day 3

In morphine equivalent dose

Outcome measures

Measure	Group 1 n=52 Participants combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	Group 2 n=51 Participants sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Total Opioid Consumption	38 mg Interval 11.0 to 90.0	30 mg Interval 8.0 to 83.0

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

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

Priya Kumar, MD

University of North Carolina, Department of Anesthesiology, University of North Carolina

Phone: (919) 966-5136

Email: pkumar@aims.unc.edu,

Results disclosure agreements

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