Patients Undergoing Ankle Surgery
Conditions
Keywords
Analgesia, Duration, Popliteal Fossa Nerve Block, Dexamethasone, Buprenorphine, Additives, Ankle surgery
Brief summary
Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg 2008;106:1916-20), but unfortunately the patients still often experience moderate to severe pain after the block wears off. The investigators wish to study two additives that may prolong the period of analgesia provided by the nerve block. The additives will be studied in the context of a standardized postoperative multimodal analgesic pathway. Primary outcome: Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?
Interventions
DRUGA. Control Nerve Block. IV Dexamethasone (4 mg).
A. Control Nerve Block. IV Dexamethasone (4 mg).
DRUGB. Nerve Block with Dexamethasone (4 mg). IV saline.
B. Nerve Block with Dexamethasone (4 mg). IV saline.
DRUGC. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
DRUGD. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
DRUGE. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients of Dr Levine or Dr Roberts. 2. Scheduled for discharge from HSS after foot or ankle surgery. 3. A single-injection popliteal fossa nerve block is judged appropriate. 4. Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion). 5. Patients aged 18-75 years.
Exclusion criteria
* Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft). * Bilateral surgery * Chronic pain (defined as regular use of opioid analgesics for \> 3 months). * Chronic use of steroids (defined as regular use of steroids for \> 3 months). * Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25% bupivacaine with clonidine (e.g. alleged bupivacaine sensitivity, low body weight, clonidine allergy, etc.). * Contraindications to dexamethasone or buprenorphine (e.g. allergy, Insulin Dependent Diabetes Mellitus, etc.) * Inability of the patient to describe postoperative pain (e.g. psychiatric disorder, dementia). * Non-English speaking patients (the questionnaire is in English, and translations would have to be separately validated)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time it Takes for Nerve Block to Wear Off | up to 72 hours | Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Nerve Block. IV Dexamethasone (4 mg). Control Nerve Block. IV Dexamethasone (4 mg).
A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg). | 17 |
| Nerve Block With Dexamethasone (4 mg). IV Saline. B. Nerve Block with Dexamethasone (4 mg). IV saline.
B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline. | 21 |
| Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) | 19 |
| Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone ( Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). | 19 |
| Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
IV saline. | 16 |
| Total | 92 |
Baseline characteristics
| Characteristic | Control Nerve Block. IV Dexamethasone (4 mg). | Nerve Block With Dexamethasone (4 mg). IV Saline. | Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp | Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone ( | Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 51.29 years STANDARD_DEVIATION 6.8 | 47.81 years STANDARD_DEVIATION 9.5 | 46.26 years STANDARD_DEVIATION 7.5 | 47.95 years STANDARD_DEVIATION 8.6 | 52.19 years STANDARD_DEVIATION 7.2 | 49.1 years STANDARD_DEVIATION 8.6 |
| Race and Ethnicity Not Collected | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 10 Participants | 14 Participants | 13 Participants | 61 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 9 Participants | 5 Participants | 3 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 21 | 0 / 19 | 0 / 19 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 21 | 0 / 19 | 0 / 19 | 0 / 16 |
Outcome results
Primary
Time it Takes for Nerve Block to Wear Off
Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?
Time frame: up to 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Nerve Block. IV Dexamethasone (4 mg). | Time it Takes for Nerve Block to Wear Off | 30.4 hours | Standard Deviation 5.1 |
| Nerve Block With Dexamethasone (4 mg). IV Saline. | Time it Takes for Nerve Block to Wear Off | 45.1 hours | Standard Deviation 5.2 |
| Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp | Time it Takes for Nerve Block to Wear Off | 32.2 hours | Standard Deviation 6.1 |
| Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone ( | Time it Takes for Nerve Block to Wear Off | 45.6 hours | Standard Deviation 5.6 |
| Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine | Time it Takes for Nerve Block to Wear Off | 45.6 hours | Standard Deviation 5.8 |