Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction
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|ClinicalTrials.gov Identifier: NCT01586806|
Recruitment Status : Completed
First Posted : April 27, 2012
Results First Posted : June 9, 2016
Last Update Posted : November 28, 2016
For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative period can be a painful experience without adequate pain management. Hence the investigators propose a randomized controlled clinical study, investigating prolonged saphenous nerve blocks. Patients will be randomized to receive saphenous nerve blocks with or without dexamethasone, a corticosteroid used to prolong analgesia.
Depending on the randomized treatment assignment, patients may receive one of the following:
- 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);
- 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;
- 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone.
Patients will be followed postoperatively. Following admission to the recovery room, data collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data collectors will also record patient satisfaction, pain medication use and any side effects experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative days 1, 2 and 14 and asked questions about their general well-being.
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Reconstruction Regional Anesthesia, Saphenous Nerve Block||Drug: Bupivacaine Only Drug: Bupivacaine with 1 mg of Dexamethasone Drug: Bupivacaine with 4 mg of Dexamethasone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||195 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||December 2014|
|Placebo Comparator: Control||
Drug: Bupivacaine Only
This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
|Active Comparator: Dexamethasone 1 mg||
Drug: Bupivacaine with 1 mg of Dexamethasone
This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
|Active Comparator: Dexamethasone 4 mg||
Drug: Bupivacaine with 4 mg of Dexamethasone
This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
- Patient-perceived Duration of Analgesia [ Time Frame: Up to 2 days following surgery ]After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.
- NRS (Numerical Rating Scale) Pain Scores [ Time Frame: Postoperative day 1 ]Patients will be asked to rate, on a scale of 0-10, their pain while at rest. 0 indicates no pain, and 10 indicates the worst pain imaginable.
- Patient Satisfaction [ Time Frame: Up to 2 days following surgery ]Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);
- Postoperative Morphine Consumption [ Time Frame: Up to 2 days following surgery ]Data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge.
- Opioid-Related Side Effects (Drowsiness) [ Time Frame: Up to 2 days following surgery ]Data collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e. drowsiness). The OR-SDS score is on a scale of 0 to 4, with a higher number representing more severe symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586806
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Mary F. Chisholm, MD||Hospital for Special Surgery, New York|