Trial Outcomes & Findings for Liposomal Bupivacaine vs Continuous Nerve Catheters for Below the Knee Amputations (NCT NCT05140499)

NCT ID: NCT05140499

Last Updated: 2026-01-27

Results Overview

Average NRS pain scores (0-10, 0=no pain, 10=worst possible pain)

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: 72 hours post-operatively
• Results posted on: 2026-01-27

Participant Flow

Participant milestones

Measure	Single Shot Perineural Popliteal Nerve Block Single shot perineural popliteal nerve block injection of 10cc 13.3% liposomal bupivacaine combined with 15cc 0.50% bupivacaine hydrochloride within one hour prior to surgery Liposomal bupivacaine: Popliteal nerve block	Continuous Perineural Popliteal Nerve Block Catheter Placement of continuous perineural popliteal nerve block catheter with injection of 30cc 0.5% bupivacaine within one hour prior to surgery, followed by continuous infusion of 10cc 0.3% ropivacaine (current standard practice) for at least 72 hours following surgery. Saphenous single shot 20cc 0.2 Bupivacaine Hydrochloride 0.5 % Injectable Solution: Continuous nerve catheter
Overall Study STARTED	5	6
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Single Shot Perineural Popliteal Nerve Block Single shot perineural popliteal nerve block injection of 10cc 13.3% liposomal bupivacaine combined with 15cc 0.50% bupivacaine hydrochloride within one hour prior to surgery Liposomal bupivacaine: Popliteal nerve block	Continuous Perineural Popliteal Nerve Block Catheter Placement of continuous perineural popliteal nerve block catheter with injection of 30cc 0.5% bupivacaine within one hour prior to surgery, followed by continuous infusion of 10cc 0.3% ropivacaine (current standard practice) for at least 72 hours following surgery. Saphenous single shot 20cc 0.2 Bupivacaine Hydrochloride 0.5 % Injectable Solution: Continuous nerve catheter
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

The analysis only includes participants who were taking a daily opioid prior to surgery.

Baseline characteristics by cohort

Measure	Single Shot Perineural Popliteal Nerve Block n=5 Participants Single shot perineural popliteal nerve block injection of 10cc 13.3% liposomal bupivacaine combined with 15cc 0.50% bupivacaine hydrochloride within one hour prior to surgery Liposomal bupivacaine: Popliteal nerve block	Continuous Perineural Popliteal Nerve Block Catheter n=6 Participants Placement of continuous perineural popliteal nerve block catheter with injection of 30cc 0.5% bupivacaine within one hour prior to surgery, followed by continuous infusion of 10cc 0.3% ropivacaine (current standard practice) for at least 72 hours following surgery. Saphenous single shot 20cc 0.2 Bupivacaine Hydrochloride 0.5 % Injectable Solution: Continuous nerve catheter	Total n=11 Participants Total of all reporting groups
Age, Continuous	61.0 years STANDARD_DEVIATION 10.1 • n=5 Participants	52.0 years STANDARD_DEVIATION 18.6 • n=6 Participants	54 years STANDARD_DEVIATION 15 • n=11 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=6 Participants	4 Participants n=11 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=6 Participants	7 Participants n=11 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=11 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=6 Participants	11 Participants n=11 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=11 Participants
Daily Opioid Use	22.5 MME/day n=2 Participants • The analysis only includes participants who were taking a daily opioid prior to surgery.	40 MME/day n=3 Participants • The analysis only includes participants who were taking a daily opioid prior to surgery.	30 MME/day n=5 Participants • The analysis only includes participants who were taking a daily opioid prior to surgery.

PRIMARY outcome

Timeframe: 72 hours post-operatively

Average NRS pain scores (0-10, 0=no pain, 10=worst possible pain)

Outcome measures

Measure	Single Shot Perineural Popliteal Nerve Block n=5 Participants Single shot perineural popliteal nerve block injection of 10cc 13.3% liposomal bupivacaine combined with 15cc 0.50% bupivacaine hydrochloride within one hour prior to surgery Liposomal bupivacaine: Popliteal nerve block	Continuous Perineural Popliteal Nerve Block Catheter n=6 Participants Placement of continuous perineural popliteal nerve block catheter with injection of 30cc 0.5% bupivacaine within one hour prior to surgery, followed by continuous infusion of 10cc 0.3% ropivacaine (current standard practice) for at least 72 hours following surgery. Saphenous single shot 20cc 0.2 Bupivacaine Hydrochloride 0.5 % Injectable Solution: Continuous nerve catheter
Pain Assessed by Numerical Rating Scale (NRS)	6 score on a scale Standard Deviation 3.07	4 score on a scale Standard Deviation 3.32

SECONDARY outcome

Timeframe: 72 hours post-operatively

Total amount of opioid medication given, in morphine milligram equivalents

Outcome measures

Measure	Single Shot Perineural Popliteal Nerve Block n=5 Participants Single shot perineural popliteal nerve block injection of 10cc 13.3% liposomal bupivacaine combined with 15cc 0.50% bupivacaine hydrochloride within one hour prior to surgery Liposomal bupivacaine: Popliteal nerve block	Continuous Perineural Popliteal Nerve Block Catheter n=6 Participants Placement of continuous perineural popliteal nerve block catheter with injection of 30cc 0.5% bupivacaine within one hour prior to surgery, followed by continuous infusion of 10cc 0.3% ropivacaine (current standard practice) for at least 72 hours following surgery. Saphenous single shot 20cc 0.2 Bupivacaine Hydrochloride 0.5 % Injectable Solution: Continuous nerve catheter
Opioid Consumption	151 MME Interval 85.0 to 330.0	47 MME Interval 15.0 to 231.0

SECONDARY outcome

Timeframe: Measured from surgical stop time to discharge time, an average of 5 days.

Post-operative length of stay in hours

Outcome measures

Measure	Single Shot Perineural Popliteal Nerve Block n=5 Participants Single shot perineural popliteal nerve block injection of 10cc 13.3% liposomal bupivacaine combined with 15cc 0.50% bupivacaine hydrochloride within one hour prior to surgery Liposomal bupivacaine: Popliteal nerve block	Continuous Perineural Popliteal Nerve Block Catheter n=6 Participants Placement of continuous perineural popliteal nerve block catheter with injection of 30cc 0.5% bupivacaine within one hour prior to surgery, followed by continuous infusion of 10cc 0.3% ropivacaine (current standard practice) for at least 72 hours following surgery. Saphenous single shot 20cc 0.2 Bupivacaine Hydrochloride 0.5 % Injectable Solution: Continuous nerve catheter
Post-operative Length of Stay	121.9 hours Interval 89.0 to 145.0	118.3 hours Interval 96.9 to 340.8

SECONDARY outcome

Timeframe: 30 days following surgery

Population: 3 participants overall were lost to follow-up

Total SFMPQ-2 score (low score of 0, no pain to a high score of 220, worst possible pain)

Outcome measures

Measure	Single Shot Perineural Popliteal Nerve Block n=4 Participants Single shot perineural popliteal nerve block injection of 10cc 13.3% liposomal bupivacaine combined with 15cc 0.50% bupivacaine hydrochloride within one hour prior to surgery Liposomal bupivacaine: Popliteal nerve block	Continuous Perineural Popliteal Nerve Block Catheter n=4 Participants Placement of continuous perineural popliteal nerve block catheter with injection of 30cc 0.5% bupivacaine within one hour prior to surgery, followed by continuous infusion of 10cc 0.3% ropivacaine (current standard practice) for at least 72 hours following surgery. Saphenous single shot 20cc 0.2 Bupivacaine Hydrochloride 0.5 % Injectable Solution: Continuous nerve catheter
Post-operative Pain Assessed by the Short Form McGill Pain Questionnaire-2 (SFMPQ-2)	14 units on a scale Interval 0.0 to 35.0	13 units on a scale Interval 0.0 to 43.0

SECONDARY outcome

Timeframe: 30 days following surgery

Population: 3 participants overall were lost to follow-up

Phantom Limb Pain was measured using questions 4 and 5 from Part II of the TAPES-R (scores can range from 0, no pain, to 22, severe pain)

Outcome measures

Measure	Single Shot Perineural Popliteal Nerve Block n=4 Participants Single shot perineural popliteal nerve block injection of 10cc 13.3% liposomal bupivacaine combined with 15cc 0.50% bupivacaine hydrochloride within one hour prior to surgery Liposomal bupivacaine: Popliteal nerve block	Continuous Perineural Popliteal Nerve Block Catheter n=4 Participants Placement of continuous perineural popliteal nerve block catheter with injection of 30cc 0.5% bupivacaine within one hour prior to surgery, followed by continuous infusion of 10cc 0.3% ropivacaine (current standard practice) for at least 72 hours following surgery. Saphenous single shot 20cc 0.2 Bupivacaine Hydrochloride 0.5 % Injectable Solution: Continuous nerve catheter
Phantom Limb Pain Assessed Using Questions From the Trinity Amputation and Prosthesis Experiences Scales-Revised (TAPES-R)	0.25 units on a scale Interval 0.0 to 1.0	0.75 units on a scale Interval 0.0 to 3.0

Adverse Events

Single Shot Perineural Popliteal Nerve Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Continuous Perineural Popliteal Nerve Block Catheter

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

Clinical Trials Director

MaineHealth Institute for Research

Phone: 207-396-8100

Email: MHIR_INFO@mainehealth.org

Results disclosure agreements

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