Overview

This trial is active, not recruiting.

Conditions anterior cruciate ligament reconstruction, regional anesthesia, saphenous nerve block
Treatments bupivacaine only, bupivacaine with 1 mg of dexamethasone, bupivacaine with 4 mg of dexamethasone
Phase phase 4
Sponsor Hospital for Special Surgery, New York
Start date July 2012
End date November 2014
Trial size 195 participants
Trial identifier NCT01586806, IRB #2012-002

Summary

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:

1. 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);

2. 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;

3. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
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)
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)
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.

Primary Outcomes

Measure
Patient-perceived duration of analgesia
time frame: Up to 2 days following surgery

Secondary Outcomes

Measure
NRS (numerical rating scale) Pain Scores
time frame: Up to 14 days following surgery
Patient Satisfaction
time frame: Up to 2 days following surgery
Postoperative Morphine Consumption
time frame: Up to 2 days following surgery
Opioid-Related Side Effects
time frame: Up to 2 days following surgery

Eligibility Criteria

Male or female participants from 16 years up to 65 years old.

Inclusion Criteria: - Patients undergoing ambulatory surgery for anterior cruciate ligament (ACL) reconstruction with a patella tendon autograft. - ASA I-III [American Society of Anesthesiologists (ASA) Physical Status classification system] - BMI < 35 - Smokers included - Ages 16-65 Exclusion Criteria: - Patients on steroids or requiring stress dose steroids - BMI > 35 - Patient refusal - Allergy to study medications, - NRS scores > 3 with frequent opioid use (including tramadol) prior to surgery—daily for greater than 3 weeks - Lower extremity neurological dysfunction - Diabetic (NIDDM, insulin-dependent and/or oral hypoglycemic dependent) - Not in included age range (under 16 or over 65 years of age) - Contraindications to the use of dexamethasone - Non-English speaking patients. We will be using the Short Form 8 Health Survey, as well as the OR-SDS questionnaire (these are in English; any translations would have to be separately validated).

Additional Information

Official title Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction
Principal investigator Mary F. Chisholm, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Hospital for Special Surgery, New York.