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

October 7, 2022 updated by: Eric Albrecht

" 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 "

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • CHUV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CI group

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.

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total i.v. morphine consumption
Time Frame: 24 hours postoperatively
i.v morphine consumption in milligrams
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total i.v. morphine consumption postoperative
Time Frame: in the postoperative care unit, at 12 hours, 36 hours, and 48 hours postoperatively
i.v morphine consumption in milligrams
in the postoperative care unit, at 12 hours, 36 hours, and 48 hours postoperatively
pain scores at rest and on movement
Time Frame: in the postoperative care unit, and twice a day during the first 48 hours postoperatively
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
presence of PONV
Time Frame: in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively
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
presence of pruritus
Time Frame: in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively
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
overall patient satisfaction rate
Time Frame: at 24 hours and 48 hours postoperatively
Numeric rating scale ranging from 0 (totally dissatisfied) to 10 (maximal satisfaction)
at 24 hours and 48 hours postoperatively
length of hospital stay
Time Frame: From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months
in days
From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months
rate of complications related to the catheter
Time Frame: From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months
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
joint amplitude during anterior elevation of the shoulder
Time Frame: at 24 hours and 48 hours postoperatively
Evaluated by physiotherapists
at 24 hours and 48 hours postoperatively
joint amplitude during shoulder abduction
Time Frame: at 24 hours and 48 hours postoperatively
Evaluated by physiotherapists
at 24 hours and 48 hours postoperatively
joint amplitude during external rotation of the shoulder
Time Frame: at 24 hours and 48 hours postoperatively
Evaluated by physiotherapists
at 24 hours and 48 hours postoperatively
pain score
Time Frame: at 3 months postoperatively
Via phone contact. Numeric pain intensity scale. Pain scores range from 0 (no pain) to 10 (worst possible pain).
at 3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 12, 2020

Primary Completion (ACTUAL)

August 31, 2022

Study Completion (ACTUAL)

September 30, 2022

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (ACTUAL)

May 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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