Analgesic Efficacy of Continuous Infusion of Local Anaesthetic Versus Single-shot Injection Interscalene Block

NCT04394130 | Completed DMC

• 1 other identifier: 2019-00957
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to study the analgesic efficacy of a continuous infusion of local anaesthetics for interscalene brachial plexus block after major shoulder surgery in the setting of multimodal analgesia, in order to determine whether the use of a catheter is still necessary in a contemporary practice.

Conditions

Analgesia

Keywords

Regional anesthesia; Brachial plexus block; Shoulder surgery; Local anesthetics; Multimodal analgesia

Outcome Measures

Primary Outcomes (1)

• total i.v. morphine consumption

  i.v morphine consumption in milligrams

  24 hours postoperatively

Secondary Outcomes (11)

• total i.v. morphine consumption postoperative

  in the postoperative care unit, at 12 hours, 36 hours, and 48 hours postoperatively

• pain scores at rest and on movement

  in the postoperative care unit, and twice a day during the first 48 hours postoperatively

• presence of PONV

  in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively

• presence of pruritus

  in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively

• overall patient satisfaction rate

  at 24 hours and 48 hours postoperatively

Study Arms (2)

CI group

EXPERIMENTAL

Patients will have a preoperative ultrasound-guided interscalene brachial plexus block with 20 ml of lidocaïne 1% and epinephrine 1:100,000, followed by the insertion of a catheter. In the post-operative period, after clinical assessment of motor recovery in the operated limb (flexion of the forearm possible) in order to exclude any neurological damage of surgical origin, ropivacaine 0.5% 20 ml will be injected through the catheter. Then a continuous infusion of ropivacaine 0.2% at a flow rate of 6 ml.h-1 will be running for 48h after the bolus administration. During surgery, patients will also receive multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg, according to the current practice in our institution.

Drug: ropivacaine 0.2%

SS group

NO INTERVENTION

Patients will have a preoperative ultrasound-guided interscalene brachial plexus block with 20 ml of lidocaïne 1% and epinephrine 1:100,000, followed by the insertion of a catheter. In the post-operative period, after clinical assessment of motor recovery in the operated limb (flexion of the forearm possible) in order to exclude any neurological damage of surgical origin, ropivacaine 0.5% 20 ml will be injected through the catheter. After the injection, the catheter will be removed. During surgery, patients will also receive multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg, according to the current practice in our institution.

Interventions

ropivacaine 0.2% DRUG

continuous peripheral nerve local anesthetic infusion (ropivacaïne 0.2 %) for 48 hours postoperative.

CI group

Eligibility Criteria

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

You may qualify if:

• patient scheduled for a major shoulder surgery (total shoulder arthroplasty or rotator cuff repair);
• ASA class 1 to 3;
• age more than 18 years old.

You may not qualify if:

• patient refusal or inability to understand and/or sign the inform consent
• contraindication for perineural block (allergy to local anesthetics, infection of puncture site, major coagulopathy, sensitive or motor deficiency on the operative side arm);
• chronic alcool abuse;
• chronic pain under chronic opioid treatment
• opioid drug abuse or under substitution treatment
• patients known for allergies to paracetamol, non steroidal anti inflammatory drugs, dexamethasone, sulfate magnesium, ondansetron, droperidol, and omeprazole;
• patients under chronic corticotherapy
• patients known for malignant hyperthermia;
• patients with chronic kidney failure class 3 or more;
• patients with severe pulmonary disease;
• patients with history of neck surgery or radiotherapy on the operative side;
• pregnancy.

Sponsors & Collaborators

• Eric Albrecht: lead

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• Rhyner P, Cachemaille M, Goetti P, Rossel JB, Boand M, Farron A, Albrecht E. Single-bolus injection of local anesthetic, with or without continuous infusion, for interscalene brachial plexus block in the setting of multimodal analgesia: a randomized controlled unblinded trial. Reg Anesth Pain Med. 2024 May 7;49(5):313-319. doi: 10.1136/rapm-2023-104681.

  PMID: 37541683 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Albrecht

  CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator PD Dr Eric Albrecht

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 19, 2020
• Study Start: May 12, 2020
• Primary Completion: August 31, 2022
• Study Completion: September 30, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)