Opioid Use, Unspecified
Conditions
Keywords
post operative pain, Dexmedetomidine, Regional anesthesia
Brief summary
The purpose of the study is to determine if perineural dexmedetomidine can provide increased prolongation of analgesia when compared to perineural dexamethasone in patients receiving regional block for shoulder surgery. If so, dexmedetomidine may serve as a superior adjunct to peripheral nerve blocks in a rapidly evolving, ambulatory-centered surgical setting.
Detailed description
Currently, the most commonly employed adjunct to peripheral nerve blockade is perineural dexamethasone. In general, at the doses used in regional anesthesia, dexamethasone has a minimal side effect profile. However, while it has been shown to increase duration of analgesia, there have been concerns regarding its neurotoxicity in animal studies. In addition, dexamethasone has the potential to cause hyperglycemia in patients with impaired glucose metabolism as well as perineal pain and pruritis when administered peripherally. Dexmedetomidine is a highly selective alpha-2 agonist that is commonly used in patients undergoing anesthesia or requiring sedation in a non-operative setting. As a peripherally administered medication, it has both sedating and analgesic properties, as well as the added benefit of avoidance of respiratory depression. Although it can rarely produce cardiac depression at high doses, its side effect profile is otherwise minimal and is generally very well tolerated by most patients. When administered peripherally, dexmedetomidine has most commonly been associated with side effects such as hypotension, respiratory depression, and bradycardia - although all at significantly higher doses than planned in our study. The safe use of perineural dexmedetomidine together with local anesthetics has been described on numerous occasions. Nevertheless, although it has been shown to potentiate peripheral nerve blockade and prolong duration of analgesia in various studies , it remains rarely used as an adjunct to regional anesthesia.
Interventions
DRUGRopivacaine
local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
DRUGDexmedetomidine
local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
DRUGDexamethasone
local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
: * ASA 1 and 2 * 18-60 years old * Patients scheduled for ambulatory arthroscopic or open surgery
Exclusion criteria
* ASA 3 and 4 * Pre-existing pain disorder * Regular consumption of chronic pain medication * Anatomical abnormalities of upper extremity * Known allergy or hypersensitivity to Ropivacaine or other amide local anesthetics * Known allergy to dexmedetomidine * Coagulopathy * Uncontrolled Diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Requirements (Morphine Equivalents) | 24 hours | How much opioid did patient ask for within 24 hours post op |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Requirements (Morphine Equivalents) | 48 hours | How much opioid did patient ask for within 48 hours post op |
| Time to Discharge From PACU to First Opioid Consumption | 24-48 hours after surgery | How long after surgery does patient take to ask for opioid to manage pain |
| Return of Motor and Sensory Function | 24-48 hours after surgery | Between 24 to 48 hours after surgery, questionnaire will be used to determine if motor and sensory function have returned. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine and Ropivacaine Group In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Dexmedetomidine: local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery | 30 |
| Dexamethasone and Ropivacaine Group In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Dexamethasone: local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery | 28 |
| Ropivacaine Only Group In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery | 31 |
| Total | 89 |
Baseline characteristics
| Characteristic | Dexmedetomidine and Ropivacaine Group | Total | Ropivacaine Only Group | Dexamethasone and Ropivacaine Group |
|---|---|---|---|---|
| Age, Continuous | 54 years | 53.5 years | 52 years | 52 years |
| Body Mass Index | 31 kg/m2 | 29 kg/m2 | 29 kg/m2 | 29 kg/m2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Sex: Female, Male Female | 18 Participants | 44 Participants | 12 Participants | 14 Participants |
| Sex: Female, Male Male | 12 Participants | 45 Participants | 19 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 28 | 0 / 31 |
| other Total, other adverse events | 0 / 30 | 0 / 28 | 0 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 28 | 0 / 31 |
Outcome results
Primary
Opioid Requirements (Morphine Equivalents)
How much opioid did patient ask for within 24 hours post op
Time frame: 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dexmedetomidine and Ropivacaine Group | Opioid Requirements (Morphine Equivalents) | 15 morphine milligram equivalent |
| Dexamethasone and Ropivacaine Group | Opioid Requirements (Morphine Equivalents) | 15 morphine milligram equivalent |
| Ropivacaine Only Group | Opioid Requirements (Morphine Equivalents) | 22.5 morphine milligram equivalent |
Secondary
Opioid Requirements (Morphine Equivalents)
How much opioid did patient ask for within 48 hours post op
Time frame: 48 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dexmedetomidine and Ropivacaine Group | Opioid Requirements (Morphine Equivalents) | 52.5 morphine milligram equivalent |
| Dexamethasone and Ropivacaine Group | Opioid Requirements (Morphine Equivalents) | 30 morphine milligram equivalent |
| Ropivacaine Only Group | Opioid Requirements (Morphine Equivalents) | 40 morphine milligram equivalent |
Secondary
Return of Motor and Sensory Function
Between 24 to 48 hours after surgery, questionnaire will be used to determine if motor and sensory function have returned.
Time frame: 24-48 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexmedetomidine and Ropivacaine Group | Return of Motor and Sensory Function | 1280 minutes |
| Dexamethasone and Ropivacaine Group | Return of Motor and Sensory Function | 1130 minutes |
| Ropivacaine Only Group | Return of Motor and Sensory Function | 900 minutes |
Secondary
Time to Discharge From PACU to First Opioid Consumption
How long after surgery does patient take to ask for opioid to manage pain
Time frame: 24-48 hours after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dexmedetomidine and Ropivacaine Group | Time to Discharge From PACU to First Opioid Consumption | 1280 minutes |
| Dexamethasone and Ropivacaine Group | Time to Discharge From PACU to First Opioid Consumption | 1130 minutes |
| Ropivacaine Only Group | Time to Discharge From PACU to First Opioid Consumption | 900 minutes |