Trial Outcomes & Findings for Preemptive Femoral & Lateral Femoral Cutaneous Nerve Blocks for THA Acute Pain (NCT NCT01997567)
NCT ID: NCT01997567
Last Updated: 2018-10-03
Results Overview
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
TERMINATED
NA
3 participants
Preoperative 2-8 wks
2018-10-03
Participant Flow
Participant milestones
| Measure |
Grp 1 Ropivacaine Block
Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)
Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)
|
Grp 2 Placebo Block
Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)
Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preemptive Femoral & Lateral Femoral Cutaneous Nerve Blocks for THA Acute Pain
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Preoperative 2-8 wksPopulation: Study was closed due to enrollment issues and data were not collected or analyzed.
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 wks postoperativePopulation: Study was closed due to enrollment issues and data were not collected or analized.
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure. Study was closed due to enrollment issues and data were not collected or analized.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 months postoperativePopulation: Study was closed due to enrollment issues and data were not collected or analyzed.
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 months postoperativePopulation: Study was closed due to enrollment issues and data were not collected or analyzed.
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Preoperative 2-8 wksPopulation: Study was closed due to enrollment issues and data were not collected or analyzed.
Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months postoperativePopulation: Study was closed due to enrollment issues and data were not collected or analyzed.
Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months postoperativePopulation: Study was closed due to enrollment issues and data were not collected or analyzed.
Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.
Outcome measures
Outcome data not reported
Adverse Events
Grp 1 Ropivacaine Block
Grp 2 Placebo Block
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sandeep Amin, M.D
Rush University Medical Center Department of Anesthesiology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place