Ultrasound Guided Supraclavicular Nerve Block

• ClinicalTrials.gov Identifier: NCT00825786
• Recruitment Status: Completed
• First Posted: January 21, 2009
• Results First Posted: April 19, 2017
• Last Update Posted: June 14, 2017
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): The Cleveland Clinic

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 (Clinical Trial)
• 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: September 2008
• Actual Primary Completion Date: August 2010
• Actual Study Completion Date: August 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. [ Time Frame: 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 [ Time Frame: during surgery from induction time to end case time ]
2. Time to Onset of First Sensory Block [ Time Frame: during surgery ]
3. Maximum Verbal Response Score (VRS) With Rest [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: postoperative day 1 to day 3 ]
   In morphine equivalent dose

Eligibility Criteria

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

Criteria

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

United States, Ohio

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

More Information

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00825786
• Other Study ID Numbers: 08-671
• First Posted: January 21, 2009
• Results First Posted: April 19, 2017
• Last Update Posted: June 14, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• 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; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents