Ultrasound Guided Supraclavicular Nerve Block

Ultrasound Guided Supraclavicular Nerve Block: Comparison Between a Mixture of Mepivacaine and Ropivacaine, and Sequential Injection of Mepivacaine Followed by Ropivacaine

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.

Study Overview

• Status: Completed
• Conditions: Local Anesthetic
• Intervention / Treatment: Drug: Ropivacaine; Drug: Mepivacaine

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 Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Complete Motor Block		during surgery from induction time to end case time
Time to Onset of First Sensory Block		during surgery
Maximum Verbal Response Score (VRS) With Rest	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	through post operative day 3
Maximum Verbal Response Score (VRS) With Movement	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	through post operative day 3
Duration of Analgesia	Time from the complete onset of sensory block until first request for an analgesic	from surgery date to postoperative day 1
Total Opioid Consumption	In morphine equivalent dose	postoperative day 1 to day 3

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Michael R Ritchey, MD, Cleveland Clinid

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: January 16, 2009
• First Submitted That Met QC Criteria: January 16, 2009
• First Posted (Estimate): January 21, 2009

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: ropivacaine; hand surgery; mepivacaine; surgery for arm hand or elbow; elbow surgery; forearm surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine; Mepivacaine
• Other Study ID Numbers: 08-671

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO