Trial Outcomes & Findings for Opioid Use in Single Shot Nerve Block vs Continuous Peripheral Nerve Infusion in Anterior Cruciate Ligament (ACL) Repair (NCT NCT02075411)

NCT ID: NCT02075411

Last Updated: 2016-05-18

Results Overview

total postoperative opioid pain medication used during the first 72 hours after the procedure

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1 participants
• Primary outcome timeframe: 72 hours post-operatively
• Results posted on: 2016-05-18

Participant Flow

Beginning in June 2014, 49 potentially eligible patients were identified. Of these, 35 patients did not meet inclusion/exclusion criteria including, and 3 patients were unable to be contacted by phone pre-operatively. Of the remaining 11 potential patients, 10 declined study participation and only 1 signed consent to participate.

Only 1 subject signed consent to participate.

Participant milestones

Measure	Males Single Shot Peripheral Nerve Block a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml). bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Males Single shot peripheral nerve block	Females Single Shot Peripheral Nerve Block a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml). bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Females Single shot peripheral nerve block	Males Continuous Peripheral Neural Infusion The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance. continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair.	Females Continuous Peripheral Neural Infusion The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance. continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair.
Overall Study STARTED	0	0	0	1
Overall Study COMPLETED	0	0	0	1
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Opioid Use in Single Shot Nerve Block vs Continuous Peripheral Nerve Infusion in Anterior Cruciate Ligament (ACL) Repair

Baseline characteristics by cohort

Measure	Males Single Shot Peripheral Nerve Block a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml). bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Males Single shot peripheral nerve block	Females Single Shot Peripheral Nerve Block a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml). bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Females Single shot peripheral nerve block	Males Continuous Peripheral Neural Infusion The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance. continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair.	Females Continuous Peripheral Neural Infusion n=1 Participants The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance. continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	—	—	1 participants n=483 Participants	1 participants n=36 Participants
Age, Categorical Between 18 and 65 years	—	—	—	0 participants n=483 Participants	0 participants n=36 Participants
Age, Categorical >=65 years	—	—	—	0 participants n=483 Participants	0 participants n=36 Participants
Gender Female	—	—	—	1 participants n=483 Participants	1 participants n=36 Participants
Gender Male	—	—	—	0 participants n=483 Participants	0 participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	—	—	0 participants n=483 Participants	0 participants n=36 Participants
Race (NIH/OMB) Asian	—	—	—	0 participants n=483 Participants	0 participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	—	—	0 participants n=483 Participants	0 participants n=36 Participants
Race (NIH/OMB) Black or African American	—	—	—	0 participants n=483 Participants	0 participants n=36 Participants
Race (NIH/OMB) White	—	—	—	1 participants n=483 Participants	1 participants n=36 Participants
Race (NIH/OMB) More than one race	—	—	—	0 participants n=483 Participants	0 participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	—	—	—	0 participants n=483 Participants	0 participants n=36 Participants
Region of Enrollment United States	—	—	—	1 participants n=483 Participants	1 participants n=36 Participants

PRIMARY outcome

Timeframe: 72 hours post-operatively

Population: Sample size was too small to conduct outcome analysis

total postoperative opioid pain medication used during the first 72 hours after the procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours post-operatively

Population: Sample size was too small to conduct outcome analysis

Determine the duration of analgesia in the 2 groups. Analgesic duration will be the time interval between the end of the operation and the time of first administration of opioid for pain relief

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 72 hours post-operatively

Population: Sample size was too small to conduct outcome analysis

We will determine the proportion of failure of the nerve block procedures as assessed by absence of a sensory block in the distribution of the femoral or sciatic nerves. The analysis will be of the numerical rating scale (NRS) scores immediately on arrival (baseline) in the recovery room and then every 6 hours over the first 72 hours post-op in the 2 groups.

Outcome measures

Outcome data not reported

Adverse Events

Males Single Shot Peripheral Nerve Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Females Single Shot Peripheral Nerve Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Males Continuous Peripheral Neural Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Females Continuous Peripheral Neural Infusion

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

Harshad Gurnaney, MBBS, MPH

Children's Hospital of Philadelphia

Phone: 215-590-1858

Email: gurnaney@email.chop.edu

Results disclosure agreements

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