Forearm and Arm SurgeryPhase 3COMBAXNCT01216488
Comparison Between Two Different Volumes of Anesthesia Drug in Forearm Surgery
A Phase 3 study testing Xylocaine in people with Forearm and Arm Surgery, run by University Hospital, Brest at 1 site in France.
Trial summary
Hospitalized patients for superior member surgery have different types of anesthesia.Forearm and/or arm surgery could be done under general anesthesia, but in the most of the cases, this surgery was done under locoregional anesthesia.Several injections of local anesthesia at the nerves axilla are used with the used of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Forearm and Arm Surgery
- What is being tested?
- Xylocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Jun 2011
- 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
- age > 18 years old
- patient who must have a non emergency surgery of the forearm or the hand
- ASA I or ASA II
- informed consent
- Ensured patient
Who cannot join
- pregnancy
- respiratory insufficiency
- cardiac insufficiency
- hepatic insufficiency
- renal insufficiency
- ASA III or IV
Show all 10Show fewer
- contraindications to the locoregional anesthesia
- contraindications to the xylocaine used
- patient participate to an another clinical study
- guardianship patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Axillary Block Under Ultrasound With 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.
Hospitalized patients for superior member surgery have different types of anesthesia.Forearm and/or arm surgery could be done under general anesthesia, but in the most of the cases, this surgery was done under locoregional anesthesia.Several injections of local anesthesia at the nerves axilla are used with the used of ultrasonography.
The purpose of this study is to show that the anesthesia efficiency is the same with 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.
Read the detailed description
Inclusion criteria :
- age > 18 years old
- patient who must have a non emergency surgery of the forearm or the hand
- ASA I or ASA II
- informed consent
- Ensured patient
Exclusion criteria :
- pregnancy
- respiratory insufficiency
- cardiac insufficiency
- hepatic insufficiency
- renal insufficiency
- ASA III or IV
- contraindications to the locoregional anesthesia
- contraindications to the xylocaine used
- patient participate to an another clinical study
- guardianship patient
- Conditions
- Forearm and Arm Surgery
- Being tested
- Xylocaine
- Keywords
- Forearm surgery, Hand surgery, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylocaineDrug
40 ml or 25 ml of Xylocaine injection
| Study group | Role | What they receive |
|---|---|---|
| 40 ml of Xylocaine | Active comparator | Not described Receives: Drug: Xylocaine |
| 25 ml of Xylocaine | Experimental | Not described Receives: Drug: Xylocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axillary block efficiency conducted by ultrasound
during the hospitalisation
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forearm and Arm SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François PICART, MD, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216488
- Sponsor's protocol ID
- RB09-060
- Acronym
- COMBAX
- Status last verified
- Dec 2011
- First submitted
- 5 Oct 2010
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Axillary Block Under Ultrasound With 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.
- ClinicalTrials.gov ID
- NCT01216488
- Acronym / sponsor ID
- COMBAX / RB09-060
- Conditions
- Forearm and Arm Surgery
- Keywords
- Forearm surgery, Hand surgery, Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Oct 2010 (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.
Hospitalized patients for superior member surgery have different types of anesthesia.Forearm and/or arm surgery could be done under general anesthesia, but in the most of the cases, this surgery was done under locoregional anesthesia.Several injections of local anesthesia at the nerves axilla are used with the used of ultrasonography.
The purpose of this study is to show that the anesthesia efficiency is the same with 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.
Detailed description
Inclusion criteria :
- age > 18 years old
- patient who must have a non emergency surgery of the forearm or the hand
- ASA I or ASA II
- informed consent
- Ensured patient
Exclusion criteria :
- pregnancy
- respiratory insufficiency
- cardiac insufficiency
- hepatic insufficiency
- renal insufficiency
- ASA III or IV
- contraindications to the locoregional anesthesia
- contraindications to the xylocaine used
- patient participate to an another clinical study
- guardianship patient
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 ml of Xylocaine | Active comparator | Drug: Xylocaine |
| 25 ml of Xylocaine | Experimental | Drug: Xylocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18 years old
- patient who must have a non emergency surgery of the forearm or the hand
- ASA I or ASA II
- informed consent
- Ensured patient
Key exclusion criteria (10 listed)
- pregnancy
- respiratory insufficiency
- cardiac insufficiency
- hepatic insufficiency
- renal insufficiency
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 |
|---|---|---|
| Xylocaine40 ml or 25 ml of Xylocaine injection | Drug | 25 ml of Xylocaine, 40 ml of Xylocaine |
Primary outcome
Axillary block efficiency conducted by ultrasound
Time frame: 48 hours
during the hospitalisation
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 21 Dec 2011.
Related trials for Forearm and Arm Surgery
Active, not recruiting
Treatment of Olecranon Fractures in the Elderly
Olecranon Fracture
Not yet recruiting
Classic Versus Interfascial Axillary Block in Hand, Wrist, and Forearm Surgery
Nerve Block, Regional Anesthesia
Recruiting
This is a Study to Find Out Whether Surgery Using a Metal Plate to Fix a Broken Elbow in Older Adults Leads to Better Recovery and Arm Function Compared to Non-surgical Treatment
Olecranon Fracture
Recruiting
The With Or Without Olecranon K-wires Trial
Olecranon Fracture
RecruitingPhase 4
A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements
Fracture Arm, Fracture Closed of Lower End of Forearm, Unspecified
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.
François PICART, MD principal investigator
CHRU BREST
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 Xylocaine in people with Forearm and Arm Surgery, run by University Hospital, Brest at 1 site in France.
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 5 inclusion and 10 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 21 Dec 2011. 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 France. 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?
Axillary block efficiency conducted by ultrasound (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2011.