Fracture of Ankle
Conditions
Keywords
Nerve Block, Anesthesia Recovery Period
Brief summary
Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The investigators are investigating the use of perineural dexamethasone together with local anesthetics can improve the quality of recovery for patients receiving sciatic nerve blocks for foot and ankle surgery.
Detailed description
Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. Perineural dexamethasone has been investigated as an adjuvant for brachial plexus nerve blocks but its effect on sciatic nerve block outcomes has yet to be determined. More importantly, it is not known whether the beneficial effect of perineural dexamethasone on analgesia duration leads to a better quality of surgical recovery. We hypothesized that perineural dexamethasone leads to a better quality of postsurgical recovery than intravenous dexamethasone or saline control.
Interventions
DRUGDexamethasone
IV dexamethsone 8mg in 50mL (diluted in NS)
DRUGSaline
2mL
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* ASA 1-3 patients who are presenting for foot and ankle surgery and are candidates for a single injection sciatic nerve block to provide postoperative analgesia. * Surgery confined to the foot and ankle. * Patients aged 18-70 years.
Exclusion criteria
* ASA Classification of 4 or higher. * Pre-existing neuropathy * Coagulopathy * Infection at the site * Diabetes * Non-English speaking or reading patients * Systemic use of corticosteroids within 6 months of surgery * Chronic opioid use * Pregnancy * Large (\>3cm) skin incision around the medial aspect of the foot * Any other contra-indication to regional anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery | 2 weeks | QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 2 weeks | Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery. |
| Pain Scores | 2 weeks | Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Perineural Dexamethasone Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion | 27 |
| Intravenous Dexamethasone Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion | 26 |
| No Perioperative Steroids Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion | 27 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Perineural Dexamethasone | Intravenous Dexamethasone | No Perioperative Steroids | Total |
|---|---|---|---|---|
| Age, Continuous | 42 years | 47 years | 39 years | 43 years |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 11 Participants | 37 Participants |
| Sex: Female, Male Male | 14 Participants | 13 Participants | 16 Participants | 43 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 / 27 | 0 / 24 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 24 | 0 / 27 |
Outcome results
Primary
Quality of Recovery
QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Perineural Dexamethasone | Quality of Recovery | 181 units on a scale |
| Intravenous Dexamethasone | Quality of Recovery | 184 units on a scale |
| No Perioperative Steroids | Quality of Recovery | 181 units on a scale |
Secondary
Opioid Consumption
Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Perineural Dexamethasone | Opioid Consumption | 0 mg/day |
| Intravenous Dexamethasone | Opioid Consumption | 0 mg/day |
| No Perioperative Steroids | Opioid Consumption | 0 mg/day |
Secondary
Pain Scores
Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain).
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Perineural Dexamethasone | Pain Scores | 2 units on a scale |
| Intravenous Dexamethasone | Pain Scores | 2.5 units on a scale |
| No Perioperative Steroids | Pain Scores | 2 units on a scale |