Comparison Between Interscalene and Combined Costoclavicular-suprascapular Blocks for Arthroscopic Shoulder Surgery

NCT04224766 | Completed

• 1 other identifier: 17200124
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative analgesia for shoulder surgery is typically achieved by providing an interscalene brachial plexus block. However, a very common side effect of this block is hemi-diaphragmatic paralysis, a state which may not be tolerated in patients with pulmonary conditions such as COPD. Recently, clinicians have explored new ways to provide satisfactory analgesia while minimizing the pulmonary side effects of the interscalene nerve block. One of these solutions might be to offer the patient a suprascapular nerve block combined to a costoclavicular block. Since these blocks are performed lower in the neck or under the clavicle, the phrenic nerve is less likely to be blocked. Thus, fewer respiratory side effects have been reported when using such blocks. This prospective observational study will evaluate the patient response to surgical stimuli and the opioid requirements intraoperatively in patients undergoing shoulder arthroscopies with either a supraclavicular and costoclavicular blocks or an interscalene block. Study Design: Prospective, randomized open label non-inferiority trial. Subject Population: Adults scheduled to undergo elective shoulder arthroscopy Sample Size: 50 patients Study Duration: Starts February 2020 - Ends February 2021 - Interim analysis at 30 patients Study Center: Assuit university hospital

Conditions

Shoulder Surgery; Regional Anesthesia Morbidity

Keywords

regional anesthesia; interscalene brachial plexus block; suprascapular and costoclavicular blocks

Outcome Measures

Primary Outcomes (2)

• pain scores on a scale from 0 to 10

  PACU pain score from 1 to 10 which 1 indicate no pain and 10 maximum pain.

  From entrance in PACU until PACU discharge e.g. up to 3 hours after surgery maximum

• naluphine consumption postoperative

  use of naluphine for postoperative analgesia in mg by asking PACU nurse questionnaire

  2 hours postoperative

Secondary Outcomes (7)

• Total dose fentanil in mcg

  Intraoperative

• Time to awakening in minutes

  Intraoperative

• Time to extubation in minutes

  Intraoperative

• Patient dyspnea on a scale from 0 to 10 in dyspnea scale

  PACU e.g. up to 3 hours after surgery maximum

• 24h pain scores on a scale from 0 to 10 at rest (NPS)

  Postoperative at H24, 24 hours after surgery

Study Arms (2)

suprascapular nerve block with costoclavicular infraclavicular

EXPERIMENTAL

Single shot US-guided suprascapular nerve block (SSNB) with 5 mL bupivacaine 0.5%, then single shot US-guided costoclavicular block (CCB) with 10 ml bupivacaine 0.5%.

Procedure: Suprascapular Nerve Block with 5ml bupivicaine 0.5%; Procedure: costoclavicular Block 10ml bupivicaine 0.5%

Interscalene brachial plexus block

ACTIVE COMPARATOR

Single shot US-guided interscalene brachial plexus block (ISBPB) with 15 mL bupivacaine 0.5%.

Procedure: Interscalene Brachial Plexus Block 15ml bupivicaine 0.5%

Interventions

Suprascapular Nerve Block with 5ml bupivicaine 0.5% PROCEDURE

The patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the proximal suprascapular nerve is visualized before it turns toward the suprascapular notch. It is blocked using 5mL of bupivicaine 0.5%.

Also known as: SSNB

suprascapular nerve block with costoclavicular infraclavicular

costoclavicular Block 10ml bupivicaine 0.5% PROCEDURE

transverse ultrasound imaging of the medial infraclavicular fossa to identify the cords of the brachial plexus at the costoclavicular space (CCS) then inject 10ml bupivicaine 0.5%

Also known as: CCB

suprascapular nerve block with costoclavicular infraclavicular

Interscalene Brachial Plexus Block 15ml bupivicaine 0.5% PROCEDURE

The patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the interscalene groove is visualized along with the roots of the brachial plexus. The block is performed with 15mL of bupivacaine 0.5%.

Also known as: ISBP

Interscalene brachial plexus block

Eligibility Criteria

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

You may qualify if:

• ASA status 1,2,3.
• Age 18 years or older
• Elective shoulder arthroscopic surgery under general anesthesia and nerve block performed preoperatively

You may not qualify if:

• Serious cardiac arrhythmias (including atrial fibrillation) or unstable coronary artery disease.
• Coagulation disorders.
• Patient refusal.
• Anatomical disorders and/or neuropathic disease.
• BMI above 40.
• History of substance abuse.
• Chronic use of psychotropic and/or opioid.
• History of psychiatric diseases needing treatment.
• Contraindications to nerve block for shoulder surgery.
• Allergy to fentanil or any drug in the study protocol.
• Failure of nerve block

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University Hospital

Asyut, 11711, Egypt

Location

Study Officials

• mohamed talaat mohamed, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: 2 groups of patients. Randomization into groups SSNP + costoclavicular or ISBPB as per randomization list, for a total of 50 patients.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 13, 2020
• Study Start: April 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

EG (1)