Interscalene Block, Shoulder Arthroscopy
Conditions
Keywords
Interscalene Block
Brief summary
The purpose of this study is to determine if a decrease in the standard volume of local anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate anesthesia for the procedure and decrease the amount of time until you are ready for discharge from the hospital.
Detailed description
Traditionally, an interscalene block is done either with nerve stimulator or ultrasound guided using 40-60mL of local anesthetic. The study plans to investigate the difference in hand grip strength post-operatively in patients who will receive interscalene blocks with 40mL versus a lower dose (20mL) of local anesthetic. We suspect the lower dose will achieve adequate surgical anesthesia while creating less motor block and thus, increase patient satisfaction, present fewer complications or adverse affects and decrease time in the recovery room.
Interventions
PROCEDURELow Dose (20 ml) Local Anesthetic Volume for Interscalene Block
Anesthetic volume: Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL
PROCEDUREControl Dose (40 mL) Local Anesthetic Volume for Interscalene Block
Anesthetic volume: Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL
DRUGLow Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)
DRUGControl Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 18 - 80 years old * Surgical time \< 2.5 hours * ASA I, II or III * Shoulder arthroscopy
Exclusion criteria
* Age \< 18 or \> 80 years old * Chronic pain patients (on narcotics/opioids \> 3 months) * Open shoulder surgical procedure * BMI \> 40 * Pre-existing neurological condition * Patient refusal of interscalene block * Severe respiratory disease or hemidiaphragmatic dysfunction * Allergy to any local anesthetics * Planned general anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip Strength | Difference between between baseline and postoperative. | The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block) and 60 minutes post-operative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Readiness to Discharge | Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes) | — |
| Duration of Analgesia | Postoperative Day 2 | Time to pain |
| Side Effects | Postoperative Day 2 | Incidence of nausea |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Dose (20 mL) Local Anesthetic Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.
Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:
Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL
Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine) | 75 |
| Control Dose (40 mL) Local Anesthetic Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine
Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:
Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL
Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine) | 77 |
| Total | 152 |
Baseline characteristics
| Characteristic | Low Dose (20 mL) Local Anesthetic | Control Dose (40 mL) Local Anesthetic | Total |
|---|---|---|---|
| Age, Continuous | 51.1 years STANDARD_DEVIATION 14.5 | 50 years STANDARD_DEVIATION 14.3 | 50.6 years STANDARD_DEVIATION 14.1 |
| Body Mass Index (BMI) | 27.6 kg/m^2 STANDARD_DEVIATION 4.2 | 26.3 kg/m^2 STANDARD_DEVIATION 3.7 | 26.8 kg/m^2 STANDARD_DEVIATION 3.9 |
| Region of Enrollment United States | 75 participants | 77 participants | 152 participants |
| Sex/Gender, Customized Female | 25.3 Percentage of participants | 26 Percentage of participants | 25.7 Percentage of participants |
| Sex/Gender, Customized Male | 74.7 Percentage of participants | 74 Percentage of participants | 74.3 Percentage of participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 75 | 0 / 77 |
| serious Total, serious adverse events | 0 / 75 | 0 / 77 |
Outcome results
Primary
Handgrip Strength
The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block) and 60 minutes post-operative.
Time frame: Difference between between baseline and postoperative.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose (20 mL) Local Anesthetic | Handgrip Strength | 6.45 kg | Standard Deviation 1.6 |
| Control Dose (40 mL) Local Anesthetic | Handgrip Strength | 2.98 kg | Standard Deviation 1.7 |
Secondary
Duration of Analgesia
Time to pain
Time frame: Postoperative Day 2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Dose (20 mL) Local Anesthetic | Duration of Analgesia | 993 minutes |
| Control Dose (40 mL) Local Anesthetic | Duration of Analgesia | 960 minutes |
Secondary
Patient Readiness to Discharge
Time frame: Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose (20 mL) Local Anesthetic | Patient Readiness to Discharge | 60 minutes | Standard Deviation 5 |
| Control Dose (40 mL) Local Anesthetic | Patient Readiness to Discharge | 65 minutes | Standard Deviation 7 |
Secondary
Side Effects
Incidence of nausea
Time frame: Postoperative Day 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose (20 mL) Local Anesthetic | Side Effects | 23 Participants |
| Control Dose (40 mL) Local Anesthetic | Side Effects | 22 Participants |