Trial Outcomes & Findings for Sciatic Technique Comparison of Nerve Blockade for Pain Control Following Hamstring Autograft Harvest in Adolescents (NCT NCT02947633)
NCT ID: NCT02947633
Last Updated: 2026-04-22
Results Overview
Guardian collects Numeric Rating Scale (NRS) pain score. The range is 0 - 10. 0 being no pain, 10 being the worst pain imaginable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
141 participants
Primary outcome timeframe
72 Hours
Results posted on
2026-04-22
Participant Flow
141 patients were enrolled in the study. Enrollment was to include 140 participants. I believe one patient was recruited accidentally. However, 123 patients completed the study, and 18 patients were withdrawn.
Patients were assigned to one of two groups. They were either in the Experimental: Continuous Sciatic PNB, or the Active Comparator: Single-injection Sciatic PNB
Participant milestones
| Measure |
Experimental : Continuous Sciatic PNB,
Patients randomized into the Continuous Sciatic PNB group will have the CPI catheter placed under ultra-sound guidance, with the tip of the catheter being placed immediately adjacent to the sciatic nerve, after the local anesthesia has been deposited. CPI catheters will only remain in-situ for 48 hours.
|
Active Comparator : Single-injection Sciatic PNB
Patients randomized into the Single-injection Sciatic PNB will go under ultrasound-guidance, where the sciatic nerve can readily be identified in the posterior thigh. The nerve appears hyperechoic and can be traced distally to the popliteal fossa, where it divides into the tibial and common peroneal nerves. Local anesthesia is injected under real-time visualization following a negative aspiration. If a single-injection block is done, local anesthesia is deposited adjacent to the sciatic nerve within the fascial plane, but not within the epineurium. As such, single-injection sciatic PNB, which can last up to 24 hours, should provide adequate analgesia precluding the need for oral narcotic or nonsteroidal anti-inflammatory medications following ACL reconstruction with a hamstring autograft.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
75
|
|
Overall Study
COMPLETED
|
63
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
18
|
Reasons for withdrawal
| Measure |
Experimental : Continuous Sciatic PNB,
Patients randomized into the Continuous Sciatic PNB group will have the CPI catheter placed under ultra-sound guidance, with the tip of the catheter being placed immediately adjacent to the sciatic nerve, after the local anesthesia has been deposited. CPI catheters will only remain in-situ for 48 hours.
|
Active Comparator : Single-injection Sciatic PNB
Patients randomized into the Single-injection Sciatic PNB will go under ultrasound-guidance, where the sciatic nerve can readily be identified in the posterior thigh. The nerve appears hyperechoic and can be traced distally to the popliteal fossa, where it divides into the tibial and common peroneal nerves. Local anesthesia is injected under real-time visualization following a negative aspiration. If a single-injection block is done, local anesthesia is deposited adjacent to the sciatic nerve within the fascial plane, but not within the epineurium. As such, single-injection sciatic PNB, which can last up to 24 hours, should provide adequate analgesia precluding the need for oral narcotic or nonsteroidal anti-inflammatory medications following ACL reconstruction with a hamstring autograft.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
18
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Single-injection Sciatic PNB
n=75 Participants
Under ultrasound-guidance, the sciatic nerve can readily be identified in the posterior thigh. The nerve appears hyperechoic and can be traced distally to the popliteal fossa, where it divides into the tibial and common peroneal nerves. Local anesthesia is injected under real-time visualization following a negative aspiration. If a single-injection block is done, local anesthesia is deposited adjacent to the sciatic nerve within the fascial plane, but not within the epineurium. As such, single-injection sciatic PNB, which can last up to 24 hours, should provide adequate analgesia precluding the need for oral narcotic or nonsteroidal anti-inflammatory medications following ACL reconstruction with a hamstring autograft.
|
Total
n=141 Participants
Total of all reporting groups
|
Continuous Sciatic PNB
n=66 Participants
If a CPI catheter is placed, the CPI catheter will be placed under ultra-sound guidance, with the tip of the catheter being placed immediately adjacent to the sciatic nerve, after the local anesthesia has been deposited. CPI catheters will only remain in-situ for 48 hours.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=75 Participants
|
9 Participants
n=141 Participants
|
3 Participants
n=66 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
69 Participants
n=75 Participants
|
132 Participants
n=141 Participants
|
63 Participants
n=66 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=75 Participants
|
0 Participants
n=141 Participants
|
0 Participants
n=66 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=75 Participants
|
72 Participants
n=141 Participants
|
37 Participants
n=66 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=75 Participants
|
69 Participants
n=141 Participants
|
29 Participants
n=66 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
—
|
PRIMARY outcome
Timeframe: 72 HoursPopulation: 18 participants were withdrawn from the study.
Guardian collects Numeric Rating Scale (NRS) pain score. The range is 0 - 10. 0 being no pain, 10 being the worst pain imaginable.
Outcome measures
| Measure |
Single-injection Sciatic PNB
n=57 Participants
Under ultrasound-guidance, the sciatic nerve can readily be identified in the posterior thigh. The nerve appears hyperechoic and can be traced distally to the popliteal fossa, where it divides into the tibial and common peroneal nerves. Local anesthesia is injected under real-time visualization following a negative aspiration. If a single-injection block is done, local anesthesia is deposited adjacent to the sciatic nerve within the fascial plane, but not within the epineurium. As such, single-injection sciatic PNB, which can last up to 24 hours, should provide adequate analgesia precluding the need for oral narcotic or nonsteroidal anti-inflammatory medications following ACL reconstruction with a hamstring autograft.
|
Continuous Sciatic PNB
n=66 Participants
If a CPI catheter is placed, the CPI catheter will be placed under ultra-sound guidance, with the tip of the catheter being placed immediately adjacent to the sciatic nerve, after the local anesthesia has been deposited. CPI catheters will only remain in-situ for 48 hours.
|
|---|---|---|
|
Pain Reduction
|
2.615 Numerical Rating Scale (NRS)
Standard Deviation 2.836
|
1.438 Numerical Rating Scale (NRS)
Standard Deviation 1.671
|
Adverse Events
Continuous Sciatic PNB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single-injection Sciatic PNB
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place