Trial Outcomes & Findings for Anesthesia for Pain After Ankle Fracture Surgery (NCT NCT02950558)

Last Updated: 2021-07-02

Results Overview

Patients will complete Self-Administered Foot and Ankle Questionnaire (SEFAS) at 12 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

at 12 months post surgery

Results posted on

2021-07-02

Participant Flow

Patients scheduled for open reduction and fixation of an ankle fracture were recruited from hospitals and outpatient surgery centers associated with the University of Cincinnati. Recruitment was delayed by a national ropivacaine shortage. Recruitment occurred between May 2018 and June 2019.

Participant milestones

Participant milestones
Measure	Standard Care Single injection of ropivacaine immediately prior to surgery Ropivacaine: Single injection of ropivacaine immediately prior to surgery.	Ropivacaine Pump Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. Ropivacaine: Single injection of ropivacaine immediately prior to surgery. Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Overall Study STARTED	8	6
Overall Study 12 Month Pain Questionnaire	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Care Single injection of ropivacaine immediately prior to surgery Ropivacaine: Single injection of ropivacaine immediately prior to surgery.	Ropivacaine Pump Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. Ropivacaine: Single injection of ropivacaine immediately prior to surgery. Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Anesthesia for Pain After Ankle Fracture Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Care n=8 Participants Single injection of ropivacaine immediately prior to surgery Ropivacaine: Single injection of ropivacaine immediately prior to surgery.	Ropivacaine Pump n=6 Participants Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. Ropivacaine: Single injection of ropivacaine immediately prior to surgery. Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	44.13 years STANDARD_DEVIATION 10.09 • n=5 Participants	43.17 years STANDARD_DEVIATION 15.41 • n=7 Participants	43.71 years STANDARD_DEVIATION 12.10 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants
BMI (body mass index)	31.17 kg/m^2 STANDARD_DEVIATION 5.538 • n=5 Participants	31.53 kg/m^2 STANDARD_DEVIATION 3.886 • n=7 Participants	31.32 kg/m^2 STANDARD_DEVIATION 4.728 • n=5 Participants

PRIMARY outcome

Timeframe: at 12 months post surgery

Population: 2 subjects in standard care group were lost to follow-up and did not complete 12 month questionnaire but their questionnaires from earlier time points were included in the analyses.

Outcome measures

Outcome measures
Measure	Standard Care n=6 Participants Single injection of ropivacaine immediately prior to surgery Ropivacaine: Single injection of ropivacaine immediately prior to surgery.	Ropivacaine Pump n=6 Participants Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. Ropivacaine: Single injection of ropivacaine immediately prior to surgery. Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Pain Score at 12 Months - Experimental Group vs. Control Group	36.33 units on a scale Standard Deviation 9.543	44.00 units on a scale Standard Deviation 1.414

SECONDARY outcome

Timeframe: at 2 weeks post surgery

Patients will complete Self-Administered Foot and Ankle Questionnaire at 2 weeks post surgery. For this instrument, 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome

Outcome measures

Outcome measures
Measure	Standard Care n=8 Participants Single injection of ropivacaine immediately prior to surgery Ropivacaine: Single injection of ropivacaine immediately prior to surgery.	Ropivacaine Pump n=6 Participants Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. Ropivacaine: Single injection of ropivacaine immediately prior to surgery. Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Pain Score at 2 Weeks - Experimental Group vs. Control Group	16.22 units on a scale Standard Deviation 6.637	13.67 units on a scale Standard Deviation 2.082

SECONDARY outcome

Timeframe: at 3 months post surgery

Patients will complete Self-Administered Foot and Ankle Questionnaire at 3 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome.

Outcome measures

Outcome measures
Measure	Standard Care n=8 Participants Single injection of ropivacaine immediately prior to surgery Ropivacaine: Single injection of ropivacaine immediately prior to surgery.	Ropivacaine Pump n=6 Participants Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. Ropivacaine: Single injection of ropivacaine immediately prior to surgery. Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Pain Score at 3 Months - Experimental Group vs. Control Group	26.25 units on a scale Standard Deviation 7.869	35.71 units on a scale Standard Deviation 5.489

SECONDARY outcome

Timeframe: at 6 months post surgery

Patients will complete Self-Administered Foot and Ankle Questionnaire at 6 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome.

Outcome measures

Outcome measures
Measure	Standard Care n=6 Participants Single injection of ropivacaine immediately prior to surgery Ropivacaine: Single injection of ropivacaine immediately prior to surgery.	Ropivacaine Pump n=6 Participants Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. Ropivacaine: Single injection of ropivacaine immediately prior to surgery. Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Pain Score at 6 Months - Experimental Group vs. Control Group	34.00 units on a scale Standard Deviation 9.011	37.67 units on a scale Standard Deviation 3.724

SECONDARY outcome

Timeframe: at 1 year post surgery

Incidence of chronic ankle pain diagnoses one year after surgery obtained from the medical record was originally planned but proved difficult to obtain. Here we provide the number of patients with a 12 month Self-Administered Foot and Ankle Questionnaire score lower than 40 at the 12 month time point. For this instrument, 48 = no pain or disability; 0 = maximum pain and disability. Scores of 40 below were interpreted to indicate ongoing ankle pain of significance for pain and function, for example, at least 8 of the 12 questions being scored less than the optimal value of 4. Scores from 40 to 48 were interpreted as indicating normal or near normal function of the affected ankle.

Outcome measures

Outcome measures
Measure	Standard Care n=6 Participants Single injection of ropivacaine immediately prior to surgery Ropivacaine: Single injection of ropivacaine immediately prior to surgery.	Ropivacaine Pump n=6 Participants Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. Ropivacaine: Single injection of ropivacaine immediately prior to surgery. Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group SEFAS Score >=40	3 Participants	6 Participants
Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group SEFAS Score <40	3 Participants	0 Participants

Adverse Events

Standard Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ropivacaine Pump

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard Care n=8 participants at risk Single injection of ropivacaine immediately prior to surgery Ropivacaine: Single injection of ropivacaine immediately prior to surgery.	Ropivacaine Pump n=6 participants at risk Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. Ropivacaine: Single injection of ropivacaine immediately prior to surgery. Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Surgical and medical procedures wound dehiscence	12.5% 1/8 • Number of events 1 • Subjects were contacted daily by phone for the first five days after surgery (which corresponded to the duration of ambulatory ropivacaine pump use for subjects in the experimental group). Medical chart records were reviewed for adverse events for 3 months following the surgery. The protocol incorporated FDA adverse event definitions and Good Clinical Practices.	0.00% 0/6 • Subjects were contacted daily by phone for the first five days after surgery (which corresponded to the duration of ambulatory ropivacaine pump use for subjects in the experimental group). Medical chart records were reviewed for adverse events for 3 months following the surgery. The protocol incorporated FDA adverse event definitions and Good Clinical Practices.
Injury, poisoning and procedural complications metalic taste around lips	0.00% 0/8 • Subjects were contacted daily by phone for the first five days after surgery (which corresponded to the duration of ambulatory ropivacaine pump use for subjects in the experimental group). Medical chart records were reviewed for adverse events for 3 months following the surgery. The protocol incorporated FDA adverse event definitions and Good Clinical Practices.	16.7% 1/6 • Number of events 1 • Subjects were contacted daily by phone for the first five days after surgery (which corresponded to the duration of ambulatory ropivacaine pump use for subjects in the experimental group). Medical chart records were reviewed for adverse events for 3 months following the surgery. The protocol incorporated FDA adverse event definitions and Good Clinical Practices.
General disorders Lightheadedness, nausea,headache	0.00% 0/8 • Subjects were contacted daily by phone for the first five days after surgery (which corresponded to the duration of ambulatory ropivacaine pump use for subjects in the experimental group). Medical chart records were reviewed for adverse events for 3 months following the surgery. The protocol incorporated FDA adverse event definitions and Good Clinical Practices.	16.7% 1/6 • Number of events 1 • Subjects were contacted daily by phone for the first five days after surgery (which corresponded to the duration of ambulatory ropivacaine pump use for subjects in the experimental group). Medical chart records were reviewed for adverse events for 3 months following the surgery. The protocol incorporated FDA adverse event definitions and Good Clinical Practices.
Gastrointestinal disorders Colitis	0.00% 0/8 • Subjects were contacted daily by phone for the first five days after surgery (which corresponded to the duration of ambulatory ropivacaine pump use for subjects in the experimental group). Medical chart records were reviewed for adverse events for 3 months following the surgery. The protocol incorporated FDA adverse event definitions and Good Clinical Practices.	16.7% 1/6 • Number of events 1 • Subjects were contacted daily by phone for the first five days after surgery (which corresponded to the duration of ambulatory ropivacaine pump use for subjects in the experimental group). Medical chart records were reviewed for adverse events for 3 months following the surgery. The protocol incorporated FDA adverse event definitions and Good Clinical Practices.

Additional Information

Jun-Ming Zhang, MD, MSc

University of Cincinnati

Phone: 5135582427

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place