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

Analgesia Clinical Trial

— BIGKIS  

Official title:

" Analgesic Efficacy of Continuous Infusion of Local Anaesthetic Versus Single-shot Injection Interscalene Brachial Plexus Block in Patients Receiving a Large Multimodal Analgesia: a Randomized Controlled Trial "

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04394130
• Other study ID #: 2019-00957
• Status: Completed
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The hypothesis of this study is that in contemporary practice, comprising the administration of multimodal analgesia, the continuous infusion of local anesthetic via a catheter remains superior in terms of analgesia at 24 h compared to a single-shot injection at the level of the interscalene brachial plexus after major shoulder surgery.

This prospective randomized monocentric superiority study will include two parallel groups: a SS (single-shot injection) group and a CI (continuous infusion) group.

All 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. In the SS group, the catheter will be removed. In the CI group, 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 of ropivacaine 0.5%.

In both groups, patients will receive during surgery 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.

Assignment to one of these two groups will be done according to a computer-generated list of random numbers, and the sealed envelopes method will be used.

In the postoperative period, patients will be prescribed an iv pca of morphine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Analgesia

Intervention

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

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Eric Albrecht

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total i.v. morphine consumption	i.v morphine consumption in milligrams	24 hours postoperatively
Secondary	total i.v. morphine consumption postoperative	i.v morphine consumption in milligrams	in the postoperative care unit, at 12 hours, 36 hours, and 48 hours postoperatively
Secondary	pain scores at rest and on movement	Numeric pain intensity scale. Pain scores range from 0 (no pain) to 10 (worst possible pain).	in the postoperative care unit, and twice a day during the first 48 hours postoperatively
Secondary	presence of PONV	verbal question to the patient if he has PONV or not	in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively
Secondary	presence of pruritus	verbal question to the patient if he has pruritus or not	in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively
Secondary	overall patient satisfaction rate	Numeric rating scale ranging from 0 (totally dissatisfied) to 10 (maximal satisfaction)	at 24 hours and 48 hours postoperatively
Secondary	length of hospital stay	in days	From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months
Secondary	rate of complications related to the catheter	infection at puncture point, catheter accidental removal	From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months
Secondary	joint amplitude during anterior elevation of the shoulder	Evaluated by physiotherapists	at 24 hours and 48 hours postoperatively
Secondary	joint amplitude during shoulder abduction	Evaluated by physiotherapists	at 24 hours and 48 hours postoperatively
Secondary	joint amplitude during external rotation of the shoulder	Evaluated by physiotherapists	at 24 hours and 48 hours postoperatively
Secondary	pain score	Via phone contact. Numeric pain intensity scale. Pain scores range from 0 (no pain) to 10 (worst possible pain).	at 3 months postoperatively