Trial Outcomes & Findings for Effect of Local Anesthetic Dose on Interscalene Block (NCT NCT01701115)
NCT ID: NCT01701115
Last Updated: 2017-10-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
154 participants
Primary outcome timeframe
Difference between between baseline and postoperative.
Results posted on
2017-10-04
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
77
|
|
Overall Study
COMPLETED
|
75
|
77
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Local Anesthetic Dose on Interscalene Block
Baseline characteristics by cohort
| Measure |
Low Dose (20 mL) Local Anesthetic
n=75 Participants
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)
|
Control Dose (40 mL) Local Anesthetic
n=77 Participants
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)
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
50 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
50.6 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
25.3 Percentage of participants
n=5 Participants
|
26 Percentage of participants
n=7 Participants
|
25.7 Percentage of participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
74.7 Percentage of participants
n=5 Participants
|
74 Percentage of participants
n=7 Participants
|
74.3 Percentage of participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
77 participants
n=7 Participants
|
152 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.6 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
26.3 kg/m^2
STANDARD_DEVIATION 3.7 • n=7 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 3.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Low Dose (20 mL) Local Anesthetic
n=75 Participants
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)
|
Control Dose (40 mL) Local Anesthetic
n=77 Participants
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)
|
|---|---|---|
|
Handgrip Strength
|
6.45 kg
Standard Deviation 1.6
|
2.98 kg
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)Outcome measures
| Measure |
Low Dose (20 mL) Local Anesthetic
n=75 Participants
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)
|
Control Dose (40 mL) Local Anesthetic
n=77 Participants
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)
|
|---|---|---|
|
Patient Readiness to Discharge
|
60 minutes
Standard Deviation 5
|
65 minutes
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Postoperative Day 2Time to pain
Outcome measures
| Measure |
Low Dose (20 mL) Local Anesthetic
n=49 Participants
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)
|
Control Dose (40 mL) Local Anesthetic
n=43 Participants
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)
|
|---|---|---|
|
Duration of Analgesia
|
993 minutes
Interval 635.0 to 1119.0
|
960 minutes
Interval 759.0 to 1340.0
|
SECONDARY outcome
Timeframe: Postoperative Day 2Incidence of nausea
Outcome measures
| Measure |
Low Dose (20 mL) Local Anesthetic
n=57 Participants
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)
|
Control Dose (40 mL) Local Anesthetic
n=55 Participants
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)
|
|---|---|---|
|
Side Effects
|
23 Participants
|
22 Participants
|
Adverse Events
Low Dose (20 mL) Local Anesthetic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Dose (40 mL) Local Anesthetic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place