Trial Outcomes & Findings for Single Shot vs Catheter Infraclavicular Brachial Plexus Block After Distal Radius Fracture Repair (NCT NCT02744352)

NCT ID: NCT02744352

Last Updated: 2020-03-25

Results Overview

Pain scores at rest and with movement.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2020-03-25

Participant Flow

Participant milestones

Measure	Continuous IBP Block Subjects will receive 60 hour continuous infraclavicular brachial plexus block (0.2% of ropivacaine at 8 milliliter/hour) with initial four intermittent 5ml bolus (20ml) of 0.5% Ropivicaine given preoperatively to help with operative and postoperative pain 20ml bolus of 0.5% ropivicaine: Local anesthetic 0.2% of ropivacaine at 8 milliliter/hour: Local anesthetic	Single Shot IBP Block Subjects will receive single shot infraclavicular brachial plexus block with 20ml bolus of 0.5% ropivicaine given preoperatively to help with operative and postoperative pain 20ml bolus of 0.5% ropivicaine: Local anesthetic
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Continuous IBP Block n=4 Participants Subjects will receive 60 hour continuous infraclavicular brachial plexus block (0.2% of ropivacaine at 8 milliliter/hour) with initial four intermittent 5ml bolus (20ml) of 0.5% Ropivicaine given preoperatively to help with operative and postoperative pain 20ml bolus of 0.5% ropivicaine: Local anesthetic 0.2% of ropivacaine at 8 milliliter/hour: Local anesthetic	Single Shot IBP Block n=4 Participants Subjects will receive single shot infraclavicular brachial plexus block with 20ml bolus of 0.5% ropivicaine given preoperatively to help with operative and postoperative pain 20ml bolus of 0.5% ropivicaine: Local anesthetic	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants	4 Participants n=4 Participants	8 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Sex: Female, Male Female	2 Participants n=4 Participants	3 Participants n=4 Participants	5 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=4 Participants	1 Participants n=4 Participants	3 Participants n=8 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 participants n=4 Participants	4 participants n=4 Participants	4 participants n=8 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: Analysis not done because study terminated prior to treatment.

Pain scores at rest and with movement.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 72 hours

Population: Analysis not done because study terminated prior to treatment.

Amount of opiate consumption

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

Population: Study was terminated before patient analysis and follow ups were completed.

Score of QoR survey to determine recovery status

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours

Population: Analysis not done because study terminated prior to treatment.

Quality of sleep first 2 nights post surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Analysis not done because study terminated prior to treatment.

Dash questionnaire to measure range of motion of the wrist and fingers 3 months after surgery

Outcome measures

Outcome data not reported

Adverse Events

Continuous IBP Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Single Shot IBP Block

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

Anmol Madaan, Clinical Research Coordinator

University of Pennsylvania

Phone: 2156623778

Email: Anmol.Madaan@Pennmedicine.Upenn.edu

Results disclosure agreements

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