Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction
|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.
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|