Effect of Local Anesthetic Dose on Interscalene Block (Low Dose ISB)
|Shoulder Arthroscopy Interscalene Block||Procedure: Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block Procedure: Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block Drug: Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine) Drug: Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Local Anesthetic Dose on Interscalene Block for Shoulder Arthroscopy, Patient Satisfaction and Return of Handgrip Strength|
- Handgrip Strength [ Time Frame: A one time assessment pre-operatively in the holding area and each hour (every hour up until 180 minutes) post-operatively in the PACU until patient discharge ]The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block), upon arrival to the PACU, every 60 minutes after entering the PACU and one reading immediately prior to patient discharge. Two measurements will be taken bilaterally at each time point.
- Patient Readiness to Discharge [ Time Frame: Participants will be followed every 15 minutes from entry into the PACU until discharge from the hospital up to 180 minutes post PACU arrival. ]
Patient readiness to discharge- Evaluated every 15 minutes using the PADDS discharge criteria.
- BP and pulse within 20% of preoperative baseline
- Steady gait, no dizziness, or meets preoperative level
- Minimal nausea and vomiting: successfully treated with PO medication
- The patient should have minimal or no pain
- Postoperative bleeding should be consistent with expected blood loss for the procedure
- Success of the Block [ Time Frame: 10 minutes post block induction in the Operating Room ]Evaluated by the level of sedation necessary and the surgeon rating of the block. The block will be considered a success if the sedation did not exceed fentanyl 100mcg or propofol 80mcg/kg/min, and the surgeon rated the block as successful with no patient movement or acceptable with minimal patient movement. Conversion to general anesthesia will also be considered a block failure.
- Patient Satisfaction [ Time Frame: POD 2 - 3 (48-72 hours after the surgical procedure) ]Patient satisfaction will be evaluated using an online survey. If the patient does not complete the survey in 2 days following discharge, the patient will receive a phone call and the survey will be completed over the phone. While the survey is not a validated measurement of patient satisfaction, it has successfully been used at our institution for other research projects (IRB # 11100).
- Side Effects [ Time Frame: Duration of stay in the PACU ]
Side effects will also be evaluated by the blinded research assistant
- Hoarseness- The patient will subjectively state whether they sound hoarse
- Horners- Will be evaluated post-operatively in the PACU
|Study Start Date:||August 2012|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
Procedure: Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block
Drug: Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)
Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL
Active Comparator: 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
Procedure: Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block
Drug: Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)
Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701115
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|