Interscalene Block Versus Costoclavicular Block for Shoulder Surgery

Not Applicable

Completed

• Conditions: Shoulder Pain; Pain, Postoperative; Surgical Procedure, Unspecified; Diaphragmatic Paralysis
• Interventions: Procedure: Interscalene Block; Procedure: Costoclavicular Infraclavicular Block

• Registration Number: NCT03411343
• Lead Sponsor: University of Chile

Brief Summary

Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease. This randomized controlled trial (RCT) will compare ultrasound-guided interscalene block (ISB) and costoclavicular infraclavicular block (CCICB) in patients undergoing arthroscopic shoulder surgery.

The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rate scale (NRS) from 0 to 10. Our research hypothesis is that interscalene and costoclavicular infraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-26
• Study Start: 2018-04-09
• Status Verified: 2018-07
• Primary Completion: 2018-07-06
• Study Completion: 2018-07-06
• Last Update Submitted: 2018-07-08
• Last Update Posted: 2018-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Patients undergoing arthroscopic shoulder surgery
• American Society of Anesthesiologists classification 1-3
• Body mass index between 20 and 35

Exclusion Criteria

• Adults who are unable to give their own consent
• Pre-existing neuropathy
• Coagulopathy
• Obstructive or restrictive pulmonary disease
• Renal failure
• Hepatic failure
• Allergy to local anesthetics
• Pregnancy
• Prior surgery in the corresponding side of the neck or infraclavicular fossa
• Chronic pain syndromes requiring opioid intake at home

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interscalene Block	Interscalene Block	Patients randomized to receive an intesrcalene block.
Costoclavicular Infraclavicular Block	Costoclavicular Infraclavicular Block	Patients randomized to receive a costoclavicular infraclavicular block.

Primary Outcome Measures

Name	Time	Method
Static pain at 30 minutes after arrival in the PACU	30 minutes	Evaluated with a NRS from 0 to 10

Secondary Outcome Measures

Name	Time	Method
Procedural pain during blocks	1 hour before surgery	Evaluated with a NRS from 0 to 10
Surgical duration	Intraoperative period	Time between skin incision and closure
Incidence of HDP at 30 minutes after interscalene or costoclavicular infraclavicular block	30 minutes post injection	Ultrasound diagnosed HDP
Block performance time	1 hour before surgery	Time from skin disinfection until the end of local anesthetic injection
Block- and opioid-related side effects	1 week	Incidence of side effects
Patient satisfaction	24 hours after surgery	Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Postoperative static pain at 2 hours	2 hours	Evaluated with a NRS from 0 to 10
Onset time	1 hour before surgery	Time required to reach a minimal sensorimotor composite score of 6 points out of a maximum of 8 points
Intraoperative opioid requirements	Intraoperative period	Total amount of fentanyl required during general anesthesia
Static pain at 60 minutes after arrival in the PACU	60 minutes	Evaluated with a NRS from 0 to 10
Postoperative static pain at 3 hours	3 hours	Evaluated with a NRS from 0 to 10
Postoperative static pain at 6 hours	6 hours	Evaluated with a NRS from 0 to 10
Postoperative static pain at 12 hours	12 hours	Evaluated with a NRS from 0 to 10
Postoperative static pain at 24 hours	24 hours	Evaluated with a NRS from 0 to 10
Sensory and Motor block score	30 minutes post injection	Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite score
Incidence of HDP at 30 minutes after arrival to PACU	30 minutes after arrival to the PACU	Ultrasound diagnosed HDP
Incidence of complete block	30 minutes post injection	Percentage of blocks with a minimal sensorimotor composite score of 6 points out of a maximum of 8 points at 30 minutes post injection
Postoperative opioid consumption	24 hours after surgery	Total amount of morphine required during the first 24 hours after surgery

Trial Locations

Locations (1)

Hospital Clínico Universidad de Chile; 🇨🇱 Santiago, Metropolitana, Chile