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Completed

NCT Number: NCT04394130

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ropivacaine 0.2%

Drug

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

Primary outcomes

  1. total i.v. morphine consumption

    Time frame: 24 hours postoperatively

    i.v morphine consumption in milligrams

Secondary outcomes

  1. 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

  2. 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).

  3. 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

  4. 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

  5. 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)

  6. 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

  7. 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

  8. joint amplitude during anterior elevation of the shoulder

    Time frame: at 24 hours and 48 hours postoperatively

    Evaluated by physiotherapists

  9. joint amplitude during shoulder abduction

    Time frame: at 24 hours and 48 hours postoperatively

    Evaluated by physiotherapists

  10. joint amplitude during external rotation of the shoulder

    Time frame: at 24 hours and 48 hours postoperatively

    Evaluated by physiotherapists

  11. 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).

Sponsors and collaborators

Lead sponsor

Eric Albrecht

Other

Registry information

Official study 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 "

Acronym: BIGKIS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 19, 2020
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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