Clinical trial NCT02970097: Single Shot Infraclavicular Brachial Plexus Block vs Local Infiltration After Wrist Arthroscopy Surgery
Official title: Comparison Between Infraclavicular Brachial Plexus Block Versus Local Infiltration for Postoperative Analgesia After Wrist Arthroscopy, a Prospective Randomized Open Label Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wrist Injuries
Postoperative Pain Control
Keywords: infraclavicular brachial plexus block
wrist arthroscopy
quality of recovery score
pain score
modified sleep quality assessment
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Scores as measured by the Visual Analog Scale
timeFrame: 72 hours
measure: Participants need for pain relief as measured by opiate consumption
timeFrame: 72 hours
Secondary outcomes:
measure: Quality of recovery score
timeFrame: 7 days
measure: quality of sleep as measured by modified Pittsburgh Sleep Quality Index
timeFrame: 72 hours
measure: Range of motion as measured by the Disability assessment of shoulder and hand questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania, Anesthesia
name: Nabil Elkassabany, MD
role: PRINCIPAL_INVESTIGATOR
References: