PainPhase 4NCT01719237
Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture
A Phase 4 study testing Ropivacine and Chloroprocaine mixture and Ropivacaine only in people with Pain, run by University of New Mexico at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Ropivacine and Chloroprocaine mixture and Ropivacaine only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Nov 2010
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will be having a supraclavicular brachial plexus block as part of their anesthetic will be approached for possible inclusion in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87106
About this study
Official title: Double Blinded Randomized Control Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture
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).
Read the 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.
- Conditions
- Pain
- Being tested
- Ropivacine and Chloroprocaine mixture, Ropivacaine only
- Keywords
- Onset, Duration, Upper Limb Block, Ultrasound guided supraclavicular block, Ropivacaine, Chloroprocaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacine and Chloroprocaine mixtureDrug
Chloroprocaine is added to Ropivacaine
Ropivacaine onlyDrug
Ropivacaine diluted with normal saline instead of chloroprocaine
| Study group | Role | What they receive |
|---|---|---|
| Ropivacine and Cholroprocaine mixture | Active comparator | 20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine Receives: Drug: Ropivacine and Chloroprocaine mixture |
| Ropivacine only | Sham comparator | 30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine Receives: Drug: Ropivacaine only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of Surgical Anesthesia
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
Measured: 45 minutes
Secondary outcomes (1)
Duration of Analgesia
Time interval between the end of local anestehtic injection and the patient's first report of pain in the surgical site after surgery
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startAug 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- VA Palo Alto Health Care System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719237
- Sponsor's protocol ID
- ChloroRopiSCB
- Status last verified
- Oct 2012
- First submitted
- 29 Oct 2012
- Last updated
- 25 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No