Single Shot Infraclavicular Brachial Plexus Block vs Local Infiltration After Wrist Arthroscopy Surgery

Comparison Between Infraclavicular Brachial Plexus Block Versus Local Infiltration for Postoperative Analgesia After Wrist Arthroscopy, a Prospective Randomized Open Label Study

The purpose of this study is to compare infraclavicular brachial plexus shot single shot block to local infiltration done in adult patients having wrist arthroscopy surgery. 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• Status: Withdrawn
• Conditions: Wrist Injuries; Postoperative Pain Control
• Intervention / Treatment: Drug: 20ml bolus of 0.5% ropivicaine; Drug: Midazolam; Drug: Fentanyl; Drug: 10 ml of 0.5% ropivicaine

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. Local Infiltration

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 local infiltration 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 local infiltration: At the end of surgery, surgeon will inject 10 ml of Ropivacaine 0.5% into the arthroscopy portals and the wrist. Specifically, 1 ml to 2 ml of Ropivacaine 0.5% will be injected into each portal with the remainder of the volume injected into the joint space itself.

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
• 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 wrist arthroscopy
• 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 light 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: 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; Other Names: Naropin; Drug: Midazolam; 1-2 mg of medication given intravenously before nerve block; Other Names: Versed; Drug: Fentanyl; 50-100 mcg of medication given intravenously before nerve block; Other Names: Sublimaze; Durogesic; Actiq; Fentora
Active Comparator: local infiltration; Subjects will receive local infiltration into portal space and joint space with 10ml of 0.5% ropivicaine given intraoperatively to help with operative and postoperative pain	Drug: 10 ml of 0.5% ropivicaine; local anesthetic; Other Names: Naropin

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	7 days
quality of sleep as measured by modified Pittsburgh Sleep Quality Index	a 9-question survey in which patients report how often sleep-related problems occur on a scale of 0 to 3	72 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 Elkassabany, MD, University of Pennsylvania, Anesthesia

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 21, 2016

Study Record Updates

• Last Update Posted (Actual): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: pain score; infraclavicular brachial plexus block; quality of recovery score; wrist arthroscopy; modified sleep quality assessment
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Wrist Injuries; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics, Local; Fentanyl; Midazolam; Ropivacaine
• Other Study ID Numbers: 825465