Clinical trial NCT00825786: Ultrasound Guided Supraclavicular Nerve Block
Official title: Ultrasound Guided Supraclavicular Nerve Block: Comparison Between a Mixture of Mepivacaine and Ropivacaine, and Sequential Injection of Mepivacaine Followed by Ropivacaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Local Anesthetic
Keywords: surgery for arm hand or elbow
mepivacaine
ropivacaine
hand surgery
elbow surgery
forearm surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Duration of Analgesia.
timeFrame: During surgery: postoperative day 0
Secondary outcomes:
measure: Time to Complete Motor Block
timeFrame: during surgery from induction time to end case time
measure: Time to Onset of First Sensory Block
timeFrame: during surgery
measure: Maximum Verbal Response Score (VRS) With Rest
timeFrame: through post operative day 3
measure: Maximum Verbal Response Score (VRS) With Movement
timeFrame: through post operative day 3
measure: Duration of Analgesia
timeFrame: from surgery date to postoperative day 1
measure: Total Opioid Consumption
timeFrame: postoperative day 1 to day 3
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Cleveland Clinid
name: Michael R Ritchey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
References: