Ultrasound Guided Supraclavicular Nerve Block

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00825786
• Collaborator: (none)
• Enrollment: 103
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90 seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local anesthetics.

Condition or Disease	Intervention/Treatment	Phase
Local Anesthetic	Drug: Ropivacaine; Drug: Mepivacaine	Phase 3

Detailed Description

Patients will be randomized into one of two groups, Group M: Ropivacaine and Mepivacaine - subject will receive two injections before surgery begins. These two injections will consist of the mixture of mepivacaine (15 ml) and ropivacaine (15 ml).

Group S: Mepivacaine followed by Ropivacaine. Subjects will receive two injections before surgery begins. One injection will contain mepivacaine (15 ml) and the other will contain ropivacaine (15 ml).

On the first, second, and third mornings after surgery,subjects will be asked to rate their pain on a scale of 1 to 10. If the subject is discharged from the hospital, a telephone call will be made to the subject's home to collect this information.

Study Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ultrasound Guided Supraclavicular Nerve Block: Comparison Between a Mixture of Mepivacaine and Ropivacaine, and Sequential Injection of Mepivacaine Followed by Ropivacaine
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;	Drug: Ropivacaine; ropivacaine (15 ml).; Drug: Mepivacaine; One syringe will contain mepivacaine (15 ml)
Active Comparator: Group 2 sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.	Drug: Ropivacaine; ropivacaine (15 ml).; Drug: Mepivacaine; One syringe will contain mepivacaine (15 ml)

Outcome Measures

Primary Outcome Measures

1. Duration of Analgesia. [During surgery: postoperative day 0]

   The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.

Secondary Outcome Measures

1. Time to Complete Motor Block [during surgery from induction time to end case time]

2. Time to Onset of First Sensory Block [during surgery]

3. Maximum Verbal Response Score (VRS) With Rest [through post operative day 3]

   The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10= worst pain

4. Maximum Verbal Response Score (VRS) With Movement [through post operative day 3]

   The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10 = worst

5. Duration of Analgesia [from surgery date to postoperative day 1]

   Time from the complete onset of sensory block until first request for an analgesic

6. Total Opioid Consumption [postoperative day 1 to day 3]

   In morphine equivalent dose

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing upper extremity procedures suitable for supraclavicular anesthesia, including but not limited to oHand surgery oForearm surgery oElbow surgery

• Age between 18 and 70 years

Exclusion Criteria:

• Contraindications to supraclavicular block

• Coagulopathy

• Infection at the needle insertion site

• Severe chronic obstructive pulmonary disease (COPD)

• Contralateral pneumothorax or diaphragmatic paralysis

• Pregnancy

• Preexisting neuropathy involving the surgical limb

• Routine opioid use

• Inability to attain adequate ultrasound images in the supraclavicular area

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Michael R Ritchey, MD, Cleveland Clinid
• Study Chair: Daniel I Sessler, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00825786
• Other Study ID Numbers: 08-671
• First Posted: Jan 21, 2009
• Last Update Posted: Jun 14, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by The Cleveland Clinic: surgery for arm hand or elbow; mepivacaine; ropivacaine; hand surgery; elbow surgery; forearm surgery
• Additional relevant MeSH terms: Ropivacaine; Mepivacaine

Study Results

Participant Flow

Arm/Group Title	Treatment	Control
Arm/Group Description	combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Period Title: Overall Study
STARTED	52	51
COMPLETED	52	51
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group 1	Group 2	Total
Arm/Group Description	combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	Total of all reporting groups
Overall Participants	52	51	103
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49 (13)	46 (14)	47 (14)
Sex: Female, Male (Count of Participants)
Female	25 48.1%	32 62.7%	57 55.3%
Male	27 51.9%	19 37.3%	46 44.7%

Outcome Measures

1. Primary Outcome

Title	Duration of Analgesia.
Description	The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.
Time Frame	During surgery: postoperative day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2
Arm/Group Description	combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Measure Participants	52	51
Median (Inter-Quartile Range) [minute]	7.5	10

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1, Group 2
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95%; 0.46 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	group 2 vs. group 1 (sequential vs combined)

2. Secondary Outcome

Title	Time to Complete Motor Block
Time Frame	during surgery from induction time to end case time

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2
Arm/Group Description	combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Measure Participants	52	51
Median (Inter-Quartile Range) [minutes]	10	19

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1, Group 2
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Log Rank
	Comments

3. Secondary Outcome

Title	Time to Onset of First Sensory Block
Time Frame	during surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2
Arm/Group Description	combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Measure Participants	52	51
Median (Inter-Quartile Range) [minutes]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1, Group 2
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments
	Method	Log Rank
	Comments

4. Secondary Outcome

Title	Maximum Verbal Response Score (VRS) With Rest
Description	The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10= worst pain
Time Frame	through post operative day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2
Arm/Group Description	combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Measure Participants	52	51
Median (Inter-Quartile Range) [mm]	4	4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1, Group 2
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.60
	Comments
	Method	ANCOVA
	Comments

5. Secondary Outcome

Title	Maximum Verbal Response Score (VRS) With Movement
Description	The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10 = worst
Time Frame	through post operative day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2
Arm/Group Description	combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Measure Participants	52	51
Median (Inter-Quartile Range) [mm]	5.5	5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1, Group 2
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.34
	Comments
	Method	ANCOVA
	Comments

6. Secondary Outcome

Title	Duration of Analgesia
Description	Time from the complete onset of sensory block until first request for an analgesic
Time Frame	from surgery date to postoperative day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2
Arm/Group Description	combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Measure Participants	52	51
Median (Inter-Quartile Range) [hours]	9	11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1, Group 2
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments
	Method	Log Rank
	Comments

7. Secondary Outcome

Title	Total Opioid Consumption
Description	In morphine equivalent dose
Time Frame	postoperative day 1 to day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2
Arm/Group Description	combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)	sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
Measure Participants	52	51
Median (Inter-Quartile Range) [mg]	38	30

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1, Group 2
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Time Frame	after surgery to hospital discharge
Arm/Group Title	Group 1		Group 2
Arm/Group Description	combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)		sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1. Ropivacaine: ropivacaine (15 ml). Mepivacaine: One syringe will contain mepivacaine (15 ml)
All Cause Mortality
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/51 (0%)
Serious Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/51 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.