Anterior Cruciate Ligament Reconstruction, Regional Anesthesia, Saphenous Nerve Block
Conditions
Keywords
Dexamethasone, Glucocorticoids, Physiological Effects of Drugs, Therapeutic Uses, Anterior Cruciate Ligament Reconstruction, Regional Anesthesia, nerve block, Ultrasonic Imaging, Post-Operative Complications: muscle weakness, pain, nausea and vomiting, Dexamethasone (as local anesthetic additive)
Brief 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.
Interventions
DRUGBupivacaine 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).
DRUGBupivacaine 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.
DRUGBupivacaine 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.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-perceived Duration of Analgesia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS (Numerical Rating Scale) Pain Scores | 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 | 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 | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control 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). | 62 |
| Dexamethasone 1 mg 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. | 61 |
| Dexamethasone 4 mg 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. | 63 |
| Total | 186 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 | 2 |
| Overall Study | Protocol Violation | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Control | Dexamethasone 1 mg | Dexamethasone 4 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 27 years STANDARD_DEVIATION 10 | 26 years STANDARD_DEVIATION 8 | 27 years STANDARD_DEVIATION 10 | 26 years STANDARD_DEVIATION 9 |
| Body Mass Index | 24 kg/(m^2) STANDARD_DEVIATION 3 | 24 kg/(m^2) STANDARD_DEVIATION 4 | 25 kg/(m^2) STANDARD_DEVIATION 3 | 25 kg/(m^2) STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 62 participants | 61 participants | 63 participants | 186 participants |
| Sex: Female, Male Female | 19 Participants | 27 Participants | 19 Participants | 65 Participants |
| Sex: Female, Male Male | 43 Participants | 34 Participants | 44 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 65 | 0 / 65 | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 | 0 / 65 | 0 / 65 |
Outcome results
Primary
Patient-perceived Duration of Analgesia
After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.
Time frame: Up to 2 days following surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Patient-perceived Duration of Analgesia | 33 hours |
| Dexamethasone 1 mg | Patient-perceived Duration of Analgesia | 41 hours |
| Dexamethasone 4 mg | Patient-perceived Duration of Analgesia | 46.5 hours |
Secondary
NRS (Numerical Rating Scale) Pain Scores
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.
Time frame: Postoperative day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | NRS (Numerical Rating Scale) Pain Scores | 3 units on a scale |
| Dexamethasone 1 mg | NRS (Numerical Rating Scale) Pain Scores | 3 units on a scale |
| Dexamethasone 4 mg | NRS (Numerical Rating Scale) Pain Scores | 2 units on a scale |
Secondary
Opioid-Related Side Effects (Drowsiness)
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.
Time frame: Up to 2 days following surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Opioid-Related Side Effects (Drowsiness) | 1.1 units on a scale |
| Dexamethasone 1 mg | Opioid-Related Side Effects (Drowsiness) | 1 units on a scale |
| Dexamethasone 4 mg | Opioid-Related Side Effects (Drowsiness) | 0 units on a scale |
Secondary
Patient Satisfaction
Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);
Time frame: Up to 2 days following surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Patient Satisfaction | 8 units on a scale |
| Dexamethasone 1 mg | Patient Satisfaction | 8 units on a scale |
| Dexamethasone 4 mg | Patient Satisfaction | 9 units on a scale |
Secondary
Postoperative Morphine Consumption
Data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge.
Time frame: Up to 2 days following surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Postoperative Morphine Consumption | 45 milligrams |
| Dexamethasone 1 mg | Postoperative Morphine Consumption | 30 milligrams |
| Dexamethasone 4 mg | Postoperative Morphine Consumption | 30 milligrams |