Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture

This study has been completed.
Sponsor:
Collaborator:
VA Palo Alto Health Care System
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01719237
First received: October 29, 2012
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

A double blinded randomized controlled trial comparing the onset and duration of the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using a long acting local anesthestic (Ropivacaine) with a mixture of a long and short acting local anesthestic (Ropivacaine-Chloroprocaine Mixture).


Condition Intervention Phase
Pain
Drug: Ropivacine and Chloroprocaine mixture
Drug: Ropivacaine only
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blinded Randomized Control Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Onset of surgical anesthesia [ Time Frame: 45 minutes ] [ Designated as safety issue: No ]
    Onset of surgical anesthesia is defined as the time after injection of local anesthetic to the time where no sensation of pinprick in the ulnar, median, radial and musculocutaneous nerves


Secondary Outcome Measures:
  • Duration of analgesia [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Time interval between the end of local anestehtic injection and the patient's first report of pain in the surgical site after surgery


Enrollment: 60
Study Start Date: August 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ropivacine and Cholroprocaine mixture
20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine
Drug: Ropivacine and Chloroprocaine mixture
Chloroprocaine is added to Ropivacaine
Sham Comparator: Ropivacine only
30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine
Drug: Ropivacaine only
Ropivacaine diluted with normal saline instead of chloroprocaine

Detailed Description:

Patients will be met preoperatively in the pre-anesthesia holding area as is typical for most orthopedic procedures. An attending anesthesiologist will evaluate the patient and planned surgical procedure and determine if the best anesthetic plan includes a supraclavicular brachial plexus block and will ensure that the patient provides informed consent for their anesthetic plan. Patients who will be having a supraclavicular brachial plexus block as part of their anesthetic will be approached for possible inclusion in the study.

The patient's surgical site will be verified by standard time out procedure. Standard monitoring will be placed including pulse oximetry, EKG, and non-invasive blood pressure cuff. A nasal canula will be placed to provide oxygen. The patient may be given midazolam IV up to 0.05 mg/kg as needed for anxiolysis. The supraclavicular brachial plexus block will be performed by either the attending anesthesiologist or a resident physician directly supervised by the attending anesthesiologist using ultrasound guidance.

The randomization envelope will be handed to an anesthesiologist not involved in the patient's care who will fill a 30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine or 20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine. The patient and the physicians performing the nerve block and the assessment after the block,will be blinded to the type of local anesthetic injected.

The physician performing the block will use standard aseptic technique and local anesthetic infiltration of the skin. Then, using ultrasound guidance and a 22g Touhy needle, a supraclavicular brachial plexus block will be placed using 25 mls of the study drug. The time of beginning of injection will be recorded. Starting at 10 minutes after injection, motor and sensory exam in the distribution of the ulnar, median, radial and musculocutaneous nerves using pinprick every 3 minutes until motor block and sensory block is complete. As has been used in prior studies, motor scores of 0, 1, and 2 will be used for no motor blockade (0), partial motor blockade (1), and complete motor blockade (2). Similarly, sensory scores will reflect no change in pinprick sensitivity (0), diminished pinprick sensitivity (1), and complete loss of sensitivity to pinprick (2). Being ready for surgical anesthesia will be defined as a score of 2 for sensory testing. Any patient not achieving a score of 2 on the sensory scale by 40 minutes will be considered a failed block. These scores will be recorded every 3 minutes until the block achieves scores of 2 and 2 or until the patient goes to the operating room (OR).

Once in the OR, data will be collected on whether or not the patient experienced pain on incision, required supplemental pain medicine or sedation, or if the patient required general anesthesia and the reason for needing general anesthesia (e.g. patient discomfort, surgeon request, etc). Post-operatively, a motor and sensory exam will again be performed on the patients for whom the nerve block did not achieve scores of 2 and 2 prior to undergoing surgery and on the patients who required general anesthesia. The patient will be given a card as a reminder to write down the time when he/she noticed pain at site of the operation for the first time and separately the time when he/she took pain medication for the first time. The night of the surgery the patient will be contacted over the phone by one of the investigators to ask the time of pain onset and pain medication administration. Additional data regarding the patient age, weight, type of surgery, and sex will be recorded.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who will be having a supraclavicular brachial plexus block as part of their anesthetic will be approached for possible inclusion in the study

Exclusion Criteria:

  • patients who are pregnant,
  • have an ASA status of IV or greater,
  • neuropathy,
  • a cast or other impediment to performing a motor or sensory exam in the arm and hand,
  • patients under the age of 18,
  • long term opioid therapy (longer than 1 month),
  • history of opioid abuse and pseudocholinesterase deficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719237

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
University of New Mexico
VA Palo Alto Health Care System
  More Information

No publications provided

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT01719237     History of Changes
Other Study ID Numbers: ChloroRopiSCB
Study First Received: October 29, 2012
Last Updated: October 31, 2012
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of New Mexico:
Onset
Duration
Upper Limb Block
Ultrasound guided supraclavicular block
Ropivacaine
Chloroprocaine

Additional relevant MeSH terms:
Chloroprocaine
Procaine
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014