Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction
NCT ID: NCT05161221
Last Updated: 2021-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
154 participants
INTERVENTIONAL
2021-12-06
2022-12-31
Brief Summary
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No study to date, to our knowledge, has evaluated the efficacy of single-dose adductor canal blockade with Exparel compared to femoral nerve catheter with bupivacaine. We pose that Exparel used for an adductor canal block can offer the benefit of a single-dose injection with extended pain control without the burden of an indwelling catheter and to avoid adverse events of femoral nerve blockade related to quadriceps weakness and dysesthesias.
The purpose of this study is to determine whether adductor canal blockade with liposomal bupivacaine (Exparel) is a safe and effective alternative to femoral nerve catheters for post-operative pain control for patients undergoing ACL reconstruction.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pre-operative femoral nerve catheter
participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery
OxyCODONE 5 mg Oral Tablet
Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control
Naproxen 500 Mg
Participant will receive Naproxen 500 Mg post surgery for pain control
Tylenol Pill
Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control
Femoral Nerve Catheter
Participants will receive pre-operative femoral nerve catheter
Pre-operative adductor canal block with liposomal bupivacaine
participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)
OxyCODONE 5 mg Oral Tablet
Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control
Naproxen 500 Mg
Participant will receive Naproxen 500 Mg post surgery for pain control
Tylenol Pill
Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control
Liposomal bupivacaine
Participants will receive pre-operative adductor canal block with liposomal bupivacaine (Exparel)
Interventions
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OxyCODONE 5 mg Oral Tablet
Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control
Naproxen 500 Mg
Participant will receive Naproxen 500 Mg post surgery for pain control
Tylenol Pill
Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control
Liposomal bupivacaine
Participants will receive pre-operative adductor canal block with liposomal bupivacaine (Exparel)
Femoral Nerve Catheter
Participants will receive pre-operative femoral nerve catheter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has not used narcotic pain medication in 3 months
3. Ages of 18+
4. Proficient in the English language
5. Willing and able to follow study protocol
Exclusion Criteria
2. Multi-ligamentous knee injuries
3. Cartilage procedures that prevented adherence to the immediate weightbearing and range of motion rehabilitation protocol
4. Patients taking baseline opioid for other injury
5. Dementia or other psychiatric illness that would preclude accurate evaluation
6. Pregnant or lactating patients
7. Non-English speakers as questionnaires are only available in English
18 Years
ALL
Yes
Sponsors
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Rothman Institute Orthopaedics
OTHER
Responsible Party
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Locations
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Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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sham21D.369
Identifier Type: -
Identifier Source: org_study_id