Analgesic Efficacy of US-Guided Interscalene Block Versus Supraclavicular Block for Ambulatory Arthroscopic Rotator Cuff Repair

NCT03743974 | Completed

• 1 other identifier: RGDS BISBSC
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ultrasound-guided interscalene block (ISB) is the reference technique for pain control after ambulatory upper limb surgery, but supraclavicular block (SCB) is an alternative procedure. We compared the efficacy of these two techniques in patients undergoing ambulatory arthroscopic rotator cuff repair (ARCR).

Conditions

Shoulder Lesions

Keywords

arthroscopic shoulder surgery; interscalene block analgesia; supraclavicular block analgesia; Ambulatory surgery for rotator cuff

Outcome Measures

Primary Outcomes (1)

• non-inferiority of BSC in relation to BIS on postoperative analgesic efficacy for arthroscopic outpatient shoulder rotator cuff repair surgery.

  Opioid oral consumption at home within 48 hours of returning home.

  2 days

Study Arms (2)

Interscalene block

ACTIVE COMPARATOR

Site of injection for ISB was the C6 plexus nerve root with a posterior in-plane approach, with neurostimulation control, and ultrasound-controlled of extra-plexus injection of the mixture posterior to the C6 root

Procedure: arthroscopic shoulder surgery of rotary cuff (ISB)

Supraclavicular block

EXPERIMENTAL

Site of injection for SCB was superficial and lateral to the trunks of the brachial plexus, and not directly deep inside the "corner pocket" zone, with neurostimulation control and visualization of the lung

Procedure: arthroscopic shoulder surgery of rotary cuff (CSB)

Interventions

arthroscopic shoulder surgery of rotary cuff (ISB) PROCEDURE

ISB were performed in the same manner by one of the two anesthesiologists in our team: (i) patients were monitored, after sedation with sublingual midazolam (0.1 mg/kg) + a single bolus of intravenous (IV) ketamine (0.2 mg/kg); (ii) ultrasound-guidance was carried out using a Kontron® or General Electric® ultrasound machine; (iii) neurostimulation was performed with a Stimuplex HNS® 12 set at 0.1 ms, 1 Hz and 1 mA stimulation, in sentinel mode, with the aim of securing the approach of the needle; (iv) a single perineural injection was performed with a 50 mm Vygon® needle containing a mixture of 100 mg levobupivacaine (20 mL, 0.5%) and clonidine (1 µg/kg patient) as is the local common protocol and in the absence of contraindications.

Interscalene block

arthroscopic shoulder surgery of rotary cuff (CSB) PROCEDURE

SCB were performed in the same manner by one of the two anesthesiologists in our team: (i) patients were monitored, after sedation with sublingual midazolam (0.1 mg/kg) + a single bolus of intravenous (IV) ketamine (0.2 mg/kg); (ii) ultrasound-guidance was carried out using a Kontron® or General Electric® ultrasound machine; (iii) neurostimulation was performed with a Stimuplex HNS® 12 set at 0.1 ms, 1 Hz and 1 mA stimulation, in sentinel mode, with the aim of securing the approach of the needle; (iv) a single perineural injection was performed with a 50 mm Vygon® needle containing a mixture of 100 mg levobupivacaine (20 mL, 0.5%) and clonidine (1 µg/kg patient) as is the local common protocol and in the absence of contraindications.

Supraclavicular block

Eligibility Criteria

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

You may qualify if:

• The patients were adults undergoing ARCR by a single surgeon (NJ), under RA and general anesthesia (GA);
• Returning home on the evening of their surgery (hospital stay \<12 h);
• Patients adults ;
• Patients with social health insurance ;
• Patient able to understand the objective and constrains of the study.

You may not qualify if:

• patients enable to return home on the evening of their surgery (for a medical or other reason);
• patients taking oral morphine derivatives before their surgery;
• patients with a contraindication for RA or in whom RA was not performed; those with a contraindication for oral morphine derivatives;
• patients who developed a complication during implementation of RA;
• patients refusing to participate in the study;
• patients whose consent was not recorded.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• Hôpital Privé Jean Mermoz. Service Dr Julien Cabaton: collaborator

MeSH Terms

Interventions

Placental Lactogen

Intervention Hierarchy (Ancestors)

Placental Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 16, 2018
• Study Start: October 3, 2016
• Primary Completion: October 2, 2017
• Study Completion: October 2, 2017
• Last Updated: November 19, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share