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

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ClinicalTrials.gov Identifier: NCT03743974
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : November 19, 2018
Sponsor:
Collaborator:
Hôpital Privé Jean Mermoz. Service Dr Julien Cabaton
Information provided by (Responsible Party):
Ramsay Générale de Santé

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).

Condition or disease Intervention/treatment Phase
Shoulder Lesions Procedure: arthroscopic shoulder surgery of rotary cuff (ISB) Procedure: arthroscopic shoulder surgery of rotary cuff (CSB) Not Applicable

Detailed Description:

The number of patients undergoing ambulatory arthroscopic rotator cuff repair (ARCR) in our center is increasing annually. This procedure is associated with significant postoperative pain and effective analgesia is required in order to develop day-case surgery. Although continuous interscalene catheter block (ISB) is considered to be the most effective analgesic technique for ARCR, the difficulties in implementing and monitoring ISB have led to many anesthesiologists preferring single injection block, so that patients can be discharged on the same day as surgery with a satisfactory level of pain control.

ISB is frequently associated with phrenic nerve block,even with low volumes of local anesthetics. Phrenic nerve block is a concern in some ambulatory surgery patients as it may lead to respiratory complications after hospital discharge, limiting the eligibility of many patients for day surgery. Changes in spirometry variables have been associated with ISB, whatever the site of injection around the roots (anterior or posterior). Nevertheless, effective regional anesthesia (RA) is essential for this surgery, because multimodal analgesia alone is insufficient.

Several alternatives to ISB exist that are associated with a decreased prevalence of phrenic nerve paresis.6 Supraclavicular block (SCB) decreases the risk of phrenic nerve involvement, particularly when guided by ultrasound. This technique, which has been linked to a risk of pneumothorax when carried out by neurostimulation only, has now been revived and is included among the RA techniques considered to be safe in terms of respiratory risk, especially when guided by ultrasound. Many studies have demonstrated a decreased risk of phrenic paresis with ultrasound-guided SCB, even with volumes as high as 20 mL. Published studies have demonstrated that SCB is an effective alternative to ISB, and many studies have shown that ultrasound-guided SCB is a safe technique for ambulatory shoulder surgery in terms of respiratory complications. SCB is therefore a real alternative to ISB for ambulatory ARCR, but comparative studies are necessary to evaluate its analgesic efficacy after patients have been discharged from hospital, particularly in terms of their oral morphine consumption at home.

Investigators carried out a monocentric, prospective, comparative study to determine whether SCB is non-inferior to ISB in terms of post-operative analgesia in patients undergoing ambulatory ARCR. Analgesic efficacy was determined by oral morphine use and/or pain scores in patients after hospital discharge. Promotor hypothesis was that SCB would provide similar or better analgesia to ISB in patients returning home on the evening of their surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of Ultrasound-Guided Interscalene Block Versus Supraclavicular Block for Ambulatory Arthroscopic Rotator Cuff Repair: a Prospective, Randomized, Single-blind, Comparative Study
Actual Study Start Date : October 3, 2016
Actual Primary Completion Date : October 2, 2017
Actual Study Completion Date : October 2, 2017

Arm Intervention/treatment
Active Comparator: Interscalene block
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)
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.

Experimental: Supraclavicular block
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)
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.




Primary Outcome Measures :
  1. non-inferiority of BSC in relation to BIS on postoperative analgesic efficacy for arthroscopic outpatient shoulder rotator cuff repair surgery. [ Time Frame: 2 days ]
    Opioid oral consumption at home within 48 hours of returning home.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion criteria:

  • 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.
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Responsible Party: Ramsay Générale de Santé
ClinicalTrials.gov Identifier: NCT03743974    
Other Study ID Numbers: RGDS BISBSC
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ramsay Générale de Santé:
arthroscopic shoulder surgery
interscalene block analgesia
supraclavicular block analgesia
Ambulatory surgery for rotator cuff