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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01719237
Enrollment
60
Registered
2012-11-01
Start date
2009-08-31
Completion date
2010-11-30
Last updated
2023-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Onset, Duration, Upper Limb Block, Ultrasound guided supraclavicular block, Ropivacaine, Chloroprocaine

Brief 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).

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.

Interventions

DRUGRopivacine and Chloroprocaine mixture

Chloroprocaine is added to Ropivacaine

DRUGRopivacaine only

Ropivacaine diluted with normal saline instead of chloroprocaine

Sponsors

VA Palo Alto Health Care System
CollaboratorFED
University of New Mexico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Onset of Surgical Anesthesia45 minutesOnset 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

MeasureTime frameDescription
Duration of Analgesia72 hoursTime interval between the end of local anestehtic injection and the patient's first report of pain in the surgical site after surgery

Countries

United States

Participant flow

Participants by arm

ArmCount
Ropivacaine and Cholroprocaine Mixture
20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine Ropivacine and Chloroprocaine mixture: Chloroprocaine is added to Ropivacaine
30
Ropivacaine 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 Ropivacaine only: Ropivacaine diluted with normal saline instead of chloroprocaine
29
Total59

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPhysician Decision01

Baseline characteristics

CharacteristicRopivacaine and Cholroprocaine MixtureRopivacaine OnlyTotal
Age, Continuous50 years46 years48 years
BMI (Kg/m^2)30.2 kg/m^2
STANDARD_DEVIATION 8.7
28.0 kg/m^2
STANDARD_DEVIATION 5.7
29.1 kg/m^2
STANDARD_DEVIATION 7.5
Region of Enrollment
United States
30 participants29 participants59 participants
Sex: Female, Male
Female
14 Participants16 Participants30 Participants
Sex: Female, Male
Male
16 Participants13 Participants29 Participants
Weight (Kg)86.4 kilograms
STANDARD_DEVIATION 20.5
80.7 kilograms
STANDARD_DEVIATION 19
83.6 kilograms
STANDARD_DEVIATION 20

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 29
other
Total, other adverse events
4 / 301 / 29
serious
Total, serious adverse events
0 / 300 / 29

Outcome results

Primary

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

Time frame: 45 minutes

ArmMeasureGroupValue (MEDIAN)
Ropivacaine and Cholroprocaine MixtureOnset of Surgical AnesthesiaRadial-Sensory6 minutes
Ropivacaine and Cholroprocaine MixtureOnset of Surgical AnesthesiaUlnar-Sensory16 minutes
Ropivacaine and Cholroprocaine MixtureOnset of Surgical AnesthesiaMusculocutaneous-Sensory9 minutes
Ropivacaine and Cholroprocaine MixtureOnset of Surgical AnesthesiaMedian-Sensory9 minutes
Ropivacaine OnlyOnset of Surgical AnesthesiaMusculocutaneous-Sensory10 minutes
Ropivacaine OnlyOnset of Surgical AnesthesiaRadial-Sensory10 minutes
Ropivacaine OnlyOnset of Surgical AnesthesiaMedian-Sensory16 minutes
Ropivacaine OnlyOnset of Surgical AnesthesiaUlnar-Sensory22 minutes
Secondary

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

Time frame: 72 hours

ArmMeasureValue (MEDIAN)
Ropivacaine and Cholroprocaine MixtureDuration of Analgesia566 minutes
Ropivacaine OnlyDuration of Analgesia718 minutes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026