Hand InjuryPhase 4NCT02641613
Retroclavicular Versus Supraclavicular Brachial Plexus Block for Hand and Forearm Surgery
A Phase 4 study testing retroclavicular block and supraclavicular block in people with Hand Injury, run by Hôpital du Valais at 1 site in Switzerland.
Trial summary
Patients will be randomized to one of two groups: 1. Supraclavicular group: supraclavicular brachial plexus block performed with the aid of ultrasound; 2. Retroclavicular group: retroclavicular brachial plexus block performed with the aid of ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Injury
- What is being tested?
- retroclavicular block and supraclavicular block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2016to May 2018
- Phase
- Phase 4
- 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
- Adult patients who undergo forearm or hand surgery under brachial plexus block.
Who cannot join
- History of allergic reaction to local anaesthetics
- Peripheral neuropathy
- Renal or hepatic insufficiency
- Coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Retroclavicular Versus Supraclavicular Brachial Plexus Block in Patients Undergoing Forearm and Hand Surgery: a Randomized Controlled Double-blinded Trial.
Patients will be randomized to one of two groups:
- Supraclavicular group: supraclavicular brachial plexus block performed with the aid of ultrasound;
- Retroclavicular group: retroclavicular brachial plexus block performed with the aid of ultrasound.
Read the detailed description
The study will be proposed to all patients undergoing formarm or hand surgery under brachial plexus block. Patients will be randomized to one of two groups The first group - supraclavicular group - will receive an ultrasound-guided brachial plexus block via the supraclavicular approach, by injection of 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %. The second group - retroclavicular group - will receive an ultrasound-guided brachial plexus block via the retroclavicular approach, by injection of 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %. Primary outcome is success rate at 30 minutes after the injection defined as loss of sensation to pinprick in the forearm and hand. Secondary outcomes are: needling time, time to first analgesic request, postoperative opioid consumption, pain scores at 12 and 24 hours postoperatively, block-related complications, and patient satisfaction.
- Conditions
- Hand Injury
- Being tested
- retroclavicular block, supraclavicular block
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retroclavicular blockProcedure or surgery
retroclavicular block for forearm or hand surgery
supraclavicular blockProcedure or surgery
supraclavicular block for forearm or hand surgery
| Study group | Role | What they receive |
|---|---|---|
| supraclavicular | Active comparator | patients receive a supraclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 % Receives: Procedure: supraclavicular block |
| retroclavicular block | Experimental | patients receive a retroclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 % Receives: Procedure: retroclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate (loss of sensation to pinprick in the forearm and hand)
Measured: 30 minutes after the injection
Secondary outcomes (7)
Needling time in seconds
Measured: 15 min
Time to first analgesic request
Measured: 24 hours
Block-related complications
Measured: 24 hours
Postoperative opioid consumption on postoperative day 1
Measured: 24 hours
Pain scores at 12 hours postoperatively
measured on a visual analogue scale between 0 and 100
Measured: 12 hours
Pain scores on postoperative day 1
measured on a visual analogue scale between 0 and 100
Measured: 24 hours
Patient satisfaction as assessed by numerical rating scale
Patient satisfaction on a scale between 0 (= completely dissatisfied) and 10 (= completely satisfied)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2018
- Study completionMay 2018
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 Hand InjuryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital du Valais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sina Grape, Hôpital du Valais
- Investigators
- Sina Grape, MD, Principal investigator, Hopital du ValaisEric Albrecht, MD, Study director, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641613
- Sponsor's protocol ID
- CCVEM 038/15
- Status last verified
- May 2018
- First submitted
- 1 Dec 2015
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.
PubMed 30857608
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Retroclavicular Versus Supraclavicular Brachial Plexus Block in Patients Undergoing Forearm and Hand Surgery: a Randomized Controlled Double-blinded Trial.
- ClinicalTrials.gov ID
- NCT02641613
- Acronym / sponsor ID
- CCVEM 038/15
- Conditions
- Hand Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hôpital du ValaisUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 29 Dec 2015 (estimated)
- 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.
Patients will be randomized to one of two groups:
- Supraclavicular group: supraclavicular brachial plexus block performed with the aid of ultrasound;
- Retroclavicular group: retroclavicular brachial plexus block performed with the aid of ultrasound.
Detailed description
The study will be proposed to all patients undergoing formarm or hand surgery under brachial plexus block. Patients will be randomized to one of two groups The first group - supraclavicular group - will receive an ultrasound-guided brachial plexus block via the supraclavicular approach, by injection of 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %. The second group - retroclavicular group - will receive an ultrasound-guided brachial plexus block via the retroclavicular approach, by injection of 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %. Primary outcome is success rate at 30 minutes after the injection defined as loss of sensation to pinprick in the forearm and hand. Secondary outcomes are: needling time, time to first analgesic request, postoperative opioid consumption, pain scores at 12 and 24 hours postoperatively, block-related complications, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supraclavicular | Active comparator | Procedure: supraclavicular blockpatients receive a supraclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 % |
| retroclavicular block | Experimental | Procedure: retroclavicular blockpatients receive a retroclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 % |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who undergo forearm or hand surgery under brachial plexus block.
Key exclusion criteria (4 listed)
- History of allergic reaction to local anaesthetics
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 |
|---|---|---|
| retroclavicular blockretroclavicular block for forearm or hand surgery | Procedure or surgery | retroclavicular block |
| supraclavicular blocksupraclavicular block for forearm or hand surgery | Procedure or surgery | supraclavicular |
Primary outcome
Success rate (loss of sensation to pinprick in the forearm and hand)
Time frame: 30 minutes after the injection
7 secondary outcomes
Needling time in seconds
Time frame: 15 min
Time to first analgesic request
Time frame: 24 hours
Block-related complications
Time frame: 24 hours
Postoperative opioid consumption on postoperative day 1
Time frame: 24 hours
Pain scores at 12 hours postoperatively
Time frame: 12 hours
Pain scores on postoperative day 1
Time frame: 24 hours
Patient satisfaction as assessed by numerical rating scale
Time frame: 24 hours
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 9 May 2018.
- Derived from this study: PubMed 30857608Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.
- Individual participant dataSharing planned: Undecided
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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.
Sina Grape, MD principal investigator
Hopital du Valais
Eric Albrecht, MD study director
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing retroclavicular block and supraclavicular block in people with Hand Injury, run by Hôpital du Valais 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 1 inclusion and 4 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 9 May 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Success rate (loss of sensation to pinprick in the forearm and hand) (time frame: 30 minutes after the injection). 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 NCT02641613, 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 9 May 2018.