AnalgesiaBIGKISNCT04394130
Analgesic Efficacy of Continuous Infusion of Local Anaesthetic Versus Single-shot Injection Interscalene Block
A study testing ropivacaine 0.2% in people with Analgesia, run by Eric Albrecht at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia
- What is being tested?
- ropivacaine 0.2%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 May 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 "
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.
Read the 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.
- Conditions
- Analgesia
- Being tested
- ropivacaine 0.2%
- Keywords
- Regional anesthesia, Brachial plexus block, Shoulder surgery, Local anesthetics, Multimodal analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine 0.2%Drug
continuous peripheral nerve local anesthetic infusion (ropivacaïne 0.2 %) for 48 hours postoperative.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
total i.v. morphine consumption
i.v morphine consumption in milligrams
Measured: 24 hours postoperatively
Secondary outcomes (11)
total i.v. morphine consumption postoperative
i.v morphine consumption in milligrams
Measured: in the postoperative care unit, at 12 hours, 36 hours, and 48 hours postoperatively
pain scores at rest and on movement
Numeric pain intensity scale. Pain scores range from 0 (no pain) to 10 (worst possible pain).
Measured: in the postoperative care unit, and twice a day during the first 48 hours postoperatively
presence of PONV
verbal question to the patient if he has PONV or not
Measured: in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively
presence of pruritus
verbal question to the patient if he has pruritus or not
Measured: in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively
overall patient satisfaction rate
Numeric rating scale ranging from 0 (totally dissatisfied) to 10 (maximal satisfaction)
Measured: at 24 hours and 48 hours postoperatively
length of hospital stay
in days
Measured: 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
infection at puncture point, catheter accidental removal
Measured: 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
Evaluated by physiotherapists
Measured: at 24 hours and 48 hours postoperatively
joint amplitude during shoulder abduction
Evaluated by physiotherapists
Measured: at 24 hours and 48 hours postoperatively
joint amplitude during external rotation of the shoulder
Evaluated by physiotherapists
Measured: at 24 hours and 48 hours postoperatively
pain score
Via phone contact. Numeric pain intensity scale. Pain scores range from 0 (no pain) to 10 (worst possible pain).
Measured: at 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start12 May 2020
- Primary completion31 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Albrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
- Investigators
- Eric Albrecht, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394130
- Sponsor's protocol ID
- 2019-00957
- Other IDs
- 2019
- Acronym
- BIGKIS
- Status last verified
- Oct 2022
- First submitted
- 8 May 2020
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37541683
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 "
- ClinicalTrials.gov ID
- NCT04394130
- Acronym / sponsor ID
- BIGKIS / 2019-00957
- Conditions
- Analgesia
- Keywords
- Regional anesthesia, Brachial plexus block, Shoulder surgery, Local anesthetics, Multimodal analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eric AlbrechtUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CI group | Experimental | Drug: ropivacaine 0.2%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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropivacaine 0.2%continuous peripheral nerve local anesthetic infusion (ropivacaïne 0.2 %) for 48 hours postoperative. | Drug | CI group |
Primary outcome
total i.v. morphine consumption
Time frame: 24 hours postoperatively
i.v morphine consumption in milligrams
11 secondary outcomes
total i.v. morphine consumption postoperative
Time frame: 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
presence of PONV
Time frame: 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
overall patient satisfaction rate
Time frame: 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
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
joint amplitude during anterior elevation of the shoulder
Time frame: at 24 hours and 48 hours postoperatively
joint amplitude during shoulder abduction
Time frame: at 24 hours and 48 hours postoperatively
joint amplitude during external rotation of the shoulder
Time frame: at 24 hours and 48 hours postoperatively
pain score
Time frame: at 3 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Derived from this study: PubMed 37541683Rhyner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Albrecht principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ropivacaine 0.2% in people with Analgesia, run by Eric Albrecht at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total i.v. morphine consumption (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04394130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.