Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022854
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2001-08-14
Brief Title:
Pain Relief Results After Anterior Cruciate Ligament ACL Reconstruction
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Outcomes After ACL Reconstruction The Effect of Femoral Nerve Block Analgesia
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Anterior cruciate ligament ACL reconstruction is surgery that is done to repair a damaged ligament in the knee In this study we will look at whether the femoral nerve block a commonly used method for pain relief after ACL reconstruction affects the way patients feel after surgery We will study recovery during the first week after surgery and also 3-12 weeks after surgery We will give all patients spinal anesthesia Some patients will also receive a continuous femoral nerve block for 2 days or by a single injection We predict that patients who received the nerve block will have significantly improved pain results compared to patients who did not receive the nerve block
Detailed Description:
In this project we will measure outcomes of anesthesia and pain management for common orthopedic procedures The influence of nerve block pain management on outcomes after outpatient anterior cruciate ligament ACL reconstruction has not been studied especially the patients potential to return to societal productivity during the first week after surgery Therefore we have designed a randomized clinical trial to study the role of nerve block pain management techniques on patient outcomes during the first week after surgery and on recovery 3-12 weeks after surgery Our hypothesis is that patients undergoing nerve block analgesia will manifest better self-reported recovery outcomes physical function outcomes and objective measures of neuromuscular function
We will give consenting patients n270 undergoing ACL reconstruction conventional spinal anesthesia and will randomize them to receive femoral nerve block analgesia with either a single injection a continuous infusion for 2 days or saline placebo We will use goniometry to test postoperative range of motion in extension to determine whether the quadriceps femoris torque output is impaired We will compare patient-reported recovery outcomes across treatment groups using three validated health status measures suitable for daily assessment Verbal Pain Score SF-8 and the Quality of Recovery from anesthesia QoR-40 Score
We aim to determine the quality of immediate recovery from anesthesia and the extent of reported pain We will compare the effects of single injection and continuous infusion on femoral nerve analgesia to determine the better dosing strategy for these patients
We will give consenting patients n270 undergoing ACL reconstruction conventional spinal anesthesia and will randomize them to receive femoral nerve block analgesia with either a single injection a continuous infusion for 2 days or saline placebo We will use goniometry to test postoperative range of motion in extension to determine whether the quadriceps femoris torque output is impaired We will compare patient-reported recovery outcomes across treatment groups using three validated health status measures suitable for daily assessment Verbal Pain Score SF-8 and the Quality of Recovery from anesthesia QoR-40 Score
We aim to determine the quality of immediate recovery from anesthesia and the extent of reported pain We will compare the effects of single injection and continuous infusion on femoral nerve analgesia to determine the better dosing strategy for these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23AR047631 | NIH | None | None |
| NIAMS-066 | US NIH GrantContract | None | httpsreporternihgovquickSearchK23AR047631 |