Ultrasound-guided Selective Shoulder Block Versus Ultrasound-guided Interscalene Brachial Plexus Block, an RCT

NCT02415088 | Completed

• 1 other identifier: 15.26/anesth15.01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomised, observer-blinded trial to compare selective shoulder block with interscalene block. Both blocks will be placed using an ultra-sound guided technique. Primary outcome measures will be postoperative pain scores and use of rescue opioids. Secondary outcome measures will be pre- and postoperative occurence of motor deficit of the arm and dyspnea, quality of sleep in the first night after surgery as measured by a numeric rating scale and overall satisfaction with pain therapy as measured by the International Pain Outcomes questionnaire and an NRS-score (0 = not satisfied at all and 10 = very satisfied). Primary and secondary outcome measures will be assessed during the first 24hours after surgery (assessment in the postanesthetic care unit (PACU) directly after admission and before discharge and in the surgical ward at 4, 8 and 24 hours after surgery). Overall satisfaction with pain therapy will be assessed 48hours after surgery. An interscalene block is a block of the plexus brachialis in the interscelene triangle (by injecting a local anesthetic around the nerve plexus). A selective shoulder block is a block of the suprascapular and axillary nerves (by injecting a local anesthetic around these nerves).

Conditions

Pain, Postoperative

Keywords

Nerve block

Outcome Measures

Primary Outcomes (2)

• Pain Score as measured by Numeric Rating Scale

  24hours

• Use of piritramide as documented by the PCIA (patient controlled intravenous analgesia) system

  24hours

Secondary Outcomes (4)

• Subjective feeling of dyspnea as measured by a numeric rating scale

  24hours

• Motor deficit after nerve block as measured by Medical Research Council scale

  24hours

• Quality of sleep in the first night after surgery as measured by a numeric rating scale

  24hours

• Overall satisfaction as measured by the International Pain Outcomes questionnaire

  48 hours

Study Arms (2)

Interscalene block

ACTIVE COMPARATOR

block of the plexus brachialis in the interscalene region with local anaesthetics

Procedure: Interscalene block

Selective shoulder block

ACTIVE COMPARATOR

selective block of the suprascapular nerve and the axillary nerve with local anaesthetics

Procedure: Selective shoulder block

Interventions

Interscalene block PROCEDURE

block of the plexus brachialis in the interscalene region with local anaesthetics

Interscalene block

Selective shoulder block PROCEDURE

selective block of the suprascapular nerve and the axillary nerve with local anaesthetics

Selective shoulder block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective arthroscopic shoulder surgery
• elective hospital admission for one night
• age \> 18 years and \< 75 years
• American Society of Anesthesiologists (ASA) physical status classification 1, 2 of 3.

You may not qualify if:

• pregnancy
• severe obesity ( BMI \> 35)
• severe COPD (Gold≥ 3) or restrictive (FEV1 \< 50%) lungdisease
• coagulation disorders
• diabetes mellitus
• previous injury or surgery of the involved shoulder
• pre-existing neuropathy or myopathy of the involved arm
• allergy or contra-indication for the medication used in the study
• preoperative use of opioids
• infection at the puncture site
• inability to understand or speak Dutch
• inability to understand the PCIA system
• inability to understand the NRS pain score system
• refusal to participate in the study

Sponsors & Collaborators

• Stessel Björn: lead

Study Sites (1)

Jessaziekenhuis Hasselt

Hasselt, Limburg, 3500, Belgium

Location

Related Publications (1)

• Neuts A, Stessel B, Wouters PF, Dierickx C, Cools W, Ory JP, Dubois J, Jamaer L, Arijs I, Schoorens D. Selective Suprascapular and Axillary Nerve Block Versus Interscalene Plexus Block for Pain Control After Arthroscopic Shoulder Surgery: A Noninferiority Randomized Parallel-Controlled Clinical Trial. Reg Anesth Pain Med. 2018 Oct;43(7):738-744. doi: 10.1097/AAP.0000000000000777.

  PMID: 29659438 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Dirk Schoorens, MD

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 8, 2015
• First Posted: April 14, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 5, 2016

Record last verified: 2016-04

Locations

BE (1)