Nerve BlockPhase 3NCT06381622
Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block
A Phase 3 study testing Ropivacaine 0.5% Injectable Solution, Lidocaine epinephrine and Ropivacaine 0.75% Injectable Solution in people with Nerve Block and Anesthesia, Local, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to investigate how the combination of ropivacaine (a slow onset, long duration local anesthetic) with lidocaine (a rapid onset, shorter duration local anesthetic) affects the onset and duration of a lateral infraclavicular plexus brachialis (LIC) block in patients undergoing non-acute hand… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nerve Block, Anesthesia, Local, Forearm Fracture
- What is being tested?
- Ropivacaine 0.5% Injectable Solution, Lidocaine epinephrine and Ropivacaine 0.75% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Apr 2024to 23 Nov 2024
- Phase
- Phase 3
- 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
- Scheduled for non-acute hand surgery in regional anesthesia
- Scheduled for surgery on one of the following: 1) Antebrachium fractures or 2) Arthroplasty of a thumb base joint or 3) alloplasty of a thumb base joint
Who cannot join
- BMI > 40 kg/m2
- Weight < 60 kg
- Age < 18 years
- ASA physical status classification system grade > 3
- Allergy to experimental drugs
- Patients who cannot cooperate with the examinations or treatment
- Patients who do not understand or speak Danish
- Patients with peripheral or central neurological disease or nerve damage with neurological effect on the upper extremity, where surgery is required
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Combining Lidocaine and Ropivacaine on the Duration and Onset Time of an Ultrasound-guided Infraclavicular Brachial Plexus Nerve Block. a Randomized Controlled Trial
The aim of the study is to investigate how the combination of ropivacaine (a slow onset, long duration local anesthetic) with lidocaine (a rapid onset, shorter duration local anesthetic) affects the onset and duration of a lateral infraclavicular plexus brachialis (LIC) block in patients undergoing non-acute hand surgery.
- Conditions
- Nerve Block, Anesthesia, Local, Forearm Fracture, Surgery, Brachial Plexus Block
- Being tested
- Ropivacaine 0.5% Injectable Solution, Lidocaine epinephrine, Ropivacaine 0.75% Injectable Solution
- Keywords
- Anesthetics, Local, Lidocaine, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.5% Injectable SolutionDrug
30 mL Ropivacaine 5 mg/mL (= 150 mg Ropivacaine)
Lidocaine epinephrineDrug
20 mL Ropivacaine 5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 μg) / ml (= 100 mg Ropivacaine + 200 mg Lidocaine)
Ropivacaine 0.75% Injectable SolutionDrug
20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 μg)/mL (= 150 mg Ropivacaine + 200 mg Lidocaine)
| Study group | Role | What they receive |
|---|---|---|
| Control group: Ropi-5 | Active comparator | 30 ml Ropivacaine 5 mg/ml (equivalent to 150 mg Ropivacaine) Receives: Drug: Ropivacaine 0.5% Injectable Solution |
| Intervention group 1: Ropi-5+Lido-20 | Experimental | 20 mL Ropivacaine 5 mg/ml + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 100 mg Ropivacaine + 200 mg Lidocaine) Receives: Drug: Ropivacaine 0.5% Injectable Solution; Drug: Lidocaine epinephrine |
| Intervention group 2: Ropi-7.5+Lido-20 | Experimental | 20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 150 mg Ropivacaine + 200 mg Lidocaine) Receives: Drug: Lidocaine epinephrine; Drug: Ropivacaine 0.75% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time to breakthrough pain
From the completion of the LIC block to first sensation of pain from the surgical area.
Measured: 24 hours
Secondary outcomes (4)
The onset of sensory block
From the completion of the LIC block to complete sensory blockade
- Tested with refrigerator-cold glass vials.
- A 3-point scale is used for cold sensation assessment: 1 point = normal sensation of cold, 2 points = reduced sensation of cold and 3 points = no cold sensation.
- A complete sensory blockade is defined as all four tested nerves obtaining three points on the 3-point scale (no cold sensation).
This outcome is measured until the complete block is obtained, but no longer than 45 minutes.
- If a complete sensory block is not obtained after 45 minutes, the LIC block is viewed as a failed block.
Measured: Until max 45 minutes
Total duration of sensory blockade
From the completion of the LIC block until the ending of sensory blockade
Measured: 24 hours
Total duration of motor blockade
From the completion of the LIC block until the ending of motor blockade
Measured: 24 hours
Degree of motor blockade
Measured according to Manual Muscle Testing scale (4 point scale)
- At the time of complete sensory blockade (defined as all four tested nerves obtaining three points on the 3-point scale (no cold sensation)), or if complete sensory blockade is not obtained, the degree of motor blockade is tested at 45 minutes.
- Assessment is done using a 4-point Manual Muscle Testing Scale: 3 points = no difference, movement against resistance is possible, 2 points = a slight difference, movement against slight resistance is possible, 1 point = significant difference, movement is significantly compromised, 0 point = paralysis.
Measured: At complete sensory blockade and otherwise 45 minutes after block performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start18 Apr 2024
- Primary completion24 Oct 2024
- Study completion23 Nov 2024
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 Nerve BlockStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Rothe, PhD, Principal investigator, Nordsjællands Hospital, Københavns Universitet, Hillerød
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381622
- Sponsor's protocol ID
- CTA no: 2023-510028-63-00
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yousef S, Steensbaek MT, Bahuet AR, Knudsen RL, Harwood CD, Rosenstock CV, Andersen MF, Rothe C, Lange KHW, Norskov AK, Lundstrom LH. The effect of combining lidocaine and ropivacaine on the duration and onset time of an ultrasound-guided infraclavicular brachial plexus nerve block: A randomised controlled trial. Eur J Anaesthesiol. 2025 Dec 1;42(12):1046-1055. doi: 10.1097/EJA.0000000000002261. Epub 2025 Sep 1.
PubMed 40859881
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combining Lidocaine and Ropivacaine on the Duration and Onset Time of an Ultrasound-guided Infraclavicular Brachial Plexus Nerve Block. a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06381622
- Acronym / sponsor ID
- CTA no: 2023-510028-63-00
- Conditions
- Nerve Block, Anesthesia, Local, Forearm Fracture, Surgery, Brachial Plexus Block
- Keywords
- Anesthetics, Local, Lidocaine, Ropivacaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 23 Nov 2024 (actual)
- First posted
- 24 Apr 2024 (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 the study is to investigate how the combination of ropivacaine (a slow onset, long duration local anesthetic) with lidocaine (a rapid onset, shorter duration local anesthetic) affects the onset and duration of a lateral infraclavicular plexus brachialis (LIC) block in patients undergoing non-acute hand surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group: Ropi-5 | Active comparator | Drug: Ropivacaine 0.5% Injectable Solution30 ml Ropivacaine 5 mg/ml (equivalent to 150 mg Ropivacaine) |
| Intervention group 1: Ropi-5+Lido-20 | Experimental | Drug: Ropivacaine 0.5% Injectable Solution, Drug: Lidocaine epinephrine20 mL Ropivacaine 5 mg/ml + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 100 mg Ropivacaine + 200 mg Lidocaine) |
| Intervention group 2: Ropi-7.5+Lido-20 | Experimental | Drug: Lidocaine epinephrine, Drug: Ropivacaine 0.75% Injectable Solution20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 150 mg Ropivacaine + 200 mg Lidocaine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for non-acute hand surgery in regional anesthesia
- Scheduled for surgery on one of the following: 1) Antebrachium fractures or 2) Arthroplasty of a thumb base joint or 3) alloplasty of a thumb base joint
Key exclusion criteria (8 listed)
- BMI > 40 kg/m2
- Weight < 60 kg
- Age < 18 years
- ASA physical status classification system grade > 3
- Allergy to experimental drugs
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 0.5% Injectable Solution30 mL Ropivacaine 5 mg/mL (= 150 mg Ropivacaine) | Drug | Control group: Ropi-5, Intervention group 1: Ropi-5+Lido-20 |
| Lidocaine epinephrine20 mL Ropivacaine 5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 μg) / ml (= 100 mg Ropivacaine + 200 mg Lidocaine) | Drug | Intervention group 1: Ropi-5+Lido-20, Intervention group 2: Ropi-7.5+Lido-20 |
| Ropivacaine 0.75% Injectable Solution20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 μg)/mL (= 150 mg Ropivacaine + 200 mg Lidocaine) | Drug | Intervention group 2: Ropi-7.5+Lido-20 |
Primary outcome
Total time to breakthrough pain
Time frame: 24 hours
From the completion of the LIC block to first sensation of pain from the surgical area.
4 secondary outcomes
The onset of sensory block
Time frame: Until max 45 minutes
Total duration of sensory blockade
Time frame: 24 hours
Total duration of motor blockade
Time frame: 24 hours
Degree of motor blockade
Time frame: At complete sensory blockade and otherwise 45 minutes after block performance
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 17 Feb 2025.
- Derived from this study: PubMed 40859881Yousef S, Steensbaek MT, Bahuet AR, Knudsen RL, Harwood CD, Rosenstock CV, Andersen MF, Rothe C, Lange KHW, Norskov AK, Lundstrom LH. The effect of combining lidocaine and ropivacaine on the duration and onset time of an ultrasound-guided infraclavicular brachial plexus nerve block: A randomised controlled trial. Eur J Anaesthesiol. 2025 Dec 1;42(12):1046-1055. doi: 10.1097/EJA.0000000000002261. Epub 2025 Sep 1.
- Individual participant dataSharing planned: No
Related trials for Nerve Block
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Christian Rothe, PhD principal investigator
Nordsjællands Hospital, Københavns Universitet, Hillerød
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine 0.5% Injectable Solution, Lidocaine epinephrine and Ropivacaine 0.75% Injectable Solution in people with Nerve Block and Anesthesia, Local, run by Nordsjaellands Hospital at 1 site in Denmark.
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 2 inclusion and 8 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 17 Feb 2025. 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 Denmark. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 time to breakthrough pain (time frame: 24 hours). 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 NCT06381622, 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 17 Feb 2025.