Single Shot vs Catheter Infraclavicular Brachial Plexus Block After Distal Radius Fracture Repair

Comparison Between Single Shot Versus Continuous Infraclavicular Brachial Plexus Block for Postoperative Analgesia After Distal Radius Fracture: A Prospective Randomized Open Label Study

The purpose of this study is to compare infraclavicular brachial plexus shot single shot block to continuous catheter nerve block done in adult patients who have under gone surgery to repair distal radius fractures. Visual analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours post operatively will be used for comparison.

Study Overview

• Status: Terminated
• Conditions: Distal Radius Fracture; Post Operative Pain Control
• Intervention / Treatment: Drug: 20ml bolus of 0.5% ropivicaine; Drug: 0.2% of ropivacaine at 8 milliliter/hour

Detailed Description

If the patient is willing to participate and signs the consent, he/she will be randomized to one of the two treatment groups:

1. Single shot block
2. Continuous catheter

In the institution investigators usually advocate for regional anesthesia and intravenous sedation for the repair of open fracture of the distal radius.

Patients will be monitored during block performance with standard ASA monitors. All patients will receive 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect. Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation.

Block time out will be preformed according to standard operating procedure. All blocks will be done under ultrasound guidance. Sonosite S nerve machine will be used with a low frequency curvilinear (C5) US probe with 2-5 MHZ frequency. Both single shot and continuous ICB will be performed according to the SOP in the department. Ultrasound survey of the deltopectoral groove below the clavicle will take place. The axillary artery and the three cords (posterior, medial and lateral) of the brachial plexus will be identified in short axis view deeper to the pectoralis minor muscle.

For single shot blocks: A 4 inch 21 gauge single shot (B-Braun) needle will be introduced in-plane towards the posterior cord of the brachial plexus and 1-2 mL of dextrose 5% (D5%) bolus will be used to verify correct placement of the needle in the vicinity of the posterior cord and adequate spread pattern to both lateral and medical cord. 20 ml of of Ropivicaine 0.5% will be injected through the needle with intermittent aspiration after each 5 ml bolus injection.

For the continuous block: A 4 gauge 18 inch tuohy needle ( B -Braun) will be introduced towards the posterior cord as above. When the needle tip and the pattern of spread is confirmed using D5% solution, a 21 gauge catheter will be introduced 2 cm beyond the needle tip under ultrasound visualization. The needle will be withdrawn over the catheter. Injection of a total of 20 ml of ropivacaine 0.5% ( in divided 5 ml boluses with intermittent aspiration) will take place through the catheter while observing the spread of local anesthetic under ultrasound. The catheter hub will be affixed to the upper lateral chest with sterile occlusive dressings and an anchoring device.

Block success will be defined as a change in cutaneous sensation to touch with an alcohol pad in the posterior, medial and lateral cord distribution over the forearm and the hand within 30min after injection. Subjects with successful catheter placement per protocol and nerve block onset will be retained in the study. Subjects with a failed catheter insertion or misplaced catheter indicated by a lack of sensory changes will have their catheter replaced or will be single shot blocked and withdrawn from the study.

Intraoperative sedation will consist of intermittent boluses of midazolam (1-2 mg), fentanyl (50-100 mcg) and propofol infusion, titrates to sedation and patient comfort (25-50 mcg/kg/min).

All patients will receive prophylaxis for postoperative nausea and vomiting (PONV) during surgery. The protocol for prophylaxis against PONV includes administration of 4 mg of dexamethasone after induction of anesthesia and 4 mg of ondansetron 20 minutes before recovery from anesthesia. Dexamethasone is withheld if the patient has poorly controlled diabetes mellitus (DM). Uncontrolled DM will be defined as random blood glucose above 250 mg/dl.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for open reduction and internal fixation of a distal radius fracture
• American Society of Anesthesiologists (ASA) physical status I -III
• Mentally competent and able to give consent for enrollment in the study

Exclusion Criteria:

• Patient younger than 18 years old
• Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone and any of the drugs included in the standard of care
• Patients opting to go under general anesthesia and those refusing the block
• Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 6 months prior to the surgery
• BMI of 40 or more

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: continuous IBP block; Subjects will receive 60 hour continuous infraclavicular brachial plexus block (0.2% of ropivacaine at 8 milliliter/hour) with initial four intermittent 5ml bolus (20ml) of 0.5% Ropivicaine given preoperatively to help with operative and postoperative pain	Drug: 20ml bolus of 0.5% ropivicaine; Local anesthetic; Drug: 0.2% of ropivacaine at 8 milliliter/hour; Local anesthetic
Active Comparator: single shot IBP block; Subjects will receive single shot infraclavicular brachial plexus block with 20ml bolus of 0.5% ropivicaine given preoperatively to help with operative and postoperative pain	Drug: 20ml bolus of 0.5% ropivicaine; Local anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores as Measured by the Visual Analog Scale	Pain scores at rest and with movement.	72 hours
Participants Need for Pain Relief as Measured by Opiate Consumption	Amount of opiate consumption	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery Score	Score of QoR survey to determine recovery status	72 hours
Number of Subjects With Insomnia as Measured by Sleep Questionnaire	Quality of sleep first 2 nights post surgery	48 hours
Range of Motion as Measured by the Disability Assessment of Shoulder and Hand Questionnaire	Dash questionnaire to measure range of motion of the wrist and fingers 3 months after surgery	3 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Nabil M Elkassabany, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): October 5, 2018
• Study Completion (Actual): October 5, 2018

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: pain score; infraclavicular brachial plexus block; quality of recovery score; disability assessment of shoulder and hand questionnaire
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Arm Injuries; Forearm Injuries; Pain, Postoperative; Fractures, Bone; Radius Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 823323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No