Postoperative Pain
Conditions
Brief summary
This study looks at addition of medications to the local anesthetic for the nerve blockade.
Detailed description
Following major foot and ankle surgery patients complain of severe pain. Currently, Hospital for Special Surgery (HSS) usually uses nerve blocks (injections of local anesthetic near nerves supplying the lower leg) to help manage pain after this type of surgery. Patients also receive additional pain pills, including narcotics as needed. This study looks at addition of medications to the local anesthetic for the nerve blockade. The investigators hope that these medications (dexamethasone and buprenorphine) will prolong the pain relief from the nerve block. There are 3 groups in the study. One group is a control, and receives usual therapy: nerve block + pain pills. This is typically what the patient would receive as standard care if they were not in the study. One group uses a nerve block with additives (+ pain pills). One group gets a nerve block (local anesthetic only) + pain pills + intravenous buprenorphine - this is meant to see if the buprenorphine acts directly on the nerve that was blocked, or indirectly acts on the brain. Patients will be followed while in the hospital, and contacted by telephone and/or email after discharge for 2-3 days. Patients will be asked about their pain levels and the duration of their block. The investigators will enroll 90 patients.
Interventions
DRUGDexamethasone
DRUGBuprenorphine
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients of Dr. Levine or Dr. Roberts at Hospital for Special Surgery * Patients aged 18-75 * Patients scheduled for discharge from HSS after foot or ankle surgery * A single-injection popliteal fossa nerve block is judged appropriate * Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion)
Exclusion criteria
* \< 18 and \> 75 * 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 (e.g. alleged bupivacaine sensitivity, low body weight, etc.) * Contraindications to dexamethasone or buprenorphine (e.g. allergy, insulin dependent diabetes mellitus, etc.) * Patients who have been diagnosed with altered pain perception or have lack of sensation * 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 |
|---|---|---|
| Numeric Rating Scale (NRS) Pain Score With Movement | 24 hours after the popliteal block is given | Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Block Duration | 24 hours and 48 hours after the popliteal block is given | When did the nerve block entirely wear off? |
| Numeric Rating Scale (NRS) Pain Score at Rest | 24 hours after the popliteal block is given | Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain) |
| Median Time to Requiring Oral Opioids | 24 hours after the popliteal block is given | Did patient have pain requiring oral opioids? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Nerve Block + IV Dexamethasone IV Dexamethasone (4 mg)
Dexamethasone | 30 |
| Control Nerve Block + IV Dexamethasone + IV Buprenorphine IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine | 30 |
| Nerve Block With Dexamethasone + Buprenorphine in Block. Dexamethasone (4 mg) Buprenorphine (150 mcg)
Dexamethasone
Buprenorphine | 30 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 | 2 |
Baseline characteristics
| Characteristic | Total | Control Nerve Block + IV Dexamethasone | Control Nerve Block + IV Dexamethasone + IV Buprenorphine | Nerve Block With Dexamethasone + Buprenorphine in Block. |
|---|---|---|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 15 | 51.2 years STANDARD_DEVIATION 15.9 | 51.1 years STANDARD_DEVIATION 15.3 | 52.8 years STANDARD_DEVIATION 14.2 |
| BMI (Body Mass Index) | 26.6 kg/m^2 STANDARD_DEVIATION 5.05 | 27.2 kg/m^2 STANDARD_DEVIATION 5.68 | 26.3 kg/m^2 STANDARD_DEVIATION 4.37 | 26.3 kg/m^2 STANDARD_DEVIATION 5.16 |
| Region of Enrollment United States | 90 participants | 30 participants | 30 participants | 30 participants |
| Sex: Female, Male Female | 51 Participants | 16 Participants | 18 Participants | 17 Participants |
| Sex: Female, Male Male | 39 Participants | 14 Participants | 12 Participants | 13 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 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Numeric Rating Scale (NRS) Pain Score With Movement
Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)
Time frame: 24 hours after the popliteal block is given
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Nerve Block + IV Dexamethasone | Numeric Rating Scale (NRS) Pain Score With Movement | 1.9 units on a scale | Standard Deviation 2.6 |
| Control Nerve Block + IV Dexamethasone + IV Buprenorphine | Numeric Rating Scale (NRS) Pain Score With Movement | 1 units on a scale | Standard Deviation 1.6 |
| Nerve Block With Dexamethasone + Buprenorphine in Block. | Numeric Rating Scale (NRS) Pain Score With Movement | 1.3 units on a scale | Standard Deviation 2.1 |
Secondary
Block Duration
When did the nerve block entirely wear off?
Time frame: 24 hours and 48 hours after the popliteal block is given
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Nerve Block + IV Dexamethasone | Block Duration | 30 hours |
| Control Nerve Block + IV Dexamethasone + IV Buprenorphine | Block Duration | 37.9 hours |
| Nerve Block With Dexamethasone + Buprenorphine in Block. | Block Duration | 45.6 hours |
Secondary
Median Time to Requiring Oral Opioids
Did patient have pain requiring oral opioids?
Time frame: 24 hours after the popliteal block is given
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Nerve Block + IV Dexamethasone | Median Time to Requiring Oral Opioids | 25.5 hours |
| Control Nerve Block + IV Dexamethasone + IV Buprenorphine | Median Time to Requiring Oral Opioids | 30 hours |
| Nerve Block With Dexamethasone + Buprenorphine in Block. | Median Time to Requiring Oral Opioids | 35.3 hours |
Secondary
Numeric Rating Scale (NRS) Pain Score at Rest
Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)
Time frame: 24 hours after the popliteal block is given
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Nerve Block + IV Dexamethasone | Numeric Rating Scale (NRS) Pain Score at Rest | 1.8 units on a scale | Standard Error 2.5 |
| Control Nerve Block + IV Dexamethasone + IV Buprenorphine | Numeric Rating Scale (NRS) Pain Score at Rest | .9 units on a scale | Standard Error 1.3 |
| Nerve Block With Dexamethasone + Buprenorphine in Block. | Numeric Rating Scale (NRS) Pain Score at Rest | .8 units on a scale | Standard Error 1.6 |