Pain, PostoperativeNCT01463865
Selective Block of the Axillary Nerve in Postoperative Pain Management
A study testing ropivacaine and Sodium chloride in people with Pain, Postoperative, run by Hillerod Hospital, Denmark at 1 site in Denmark.
Trial summary
In this study the investigators wish to compare the effect of a selective axillary nerve block to placebo in patients undergoing arthroscopic shoulder surgery. It is the investigators hypothesis that the amount of morphine consumption in the first 4 hours postoperatively in the intervention group will be significant… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- ropivacaine and Sodium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Aug 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects undergoing arthroscopic shoulder surgery
- Age between 18 and 80 years
- ASA 1-3
- BMI between 18 and 35 kg/m2
- Subjects which have given their written informed consent
Who cannot join
- Subjects unable to cooperate to the investigation
- Subjects not understanding or speaking danish
- Subjects allergic to intervention drugs
- Daily use of strong analgesics (morphine, oxycontine, ketogan)
- Alcohol or medicine misuse
- Failure of nerve block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Block of the Axillary Nerve in Postoperative Pain Management, a Randomised, Blinded, Placebo-controlled Trial
In this study the investigators wish to compare the effect of a selective axillary nerve block to placebo in patients undergoing arthroscopic shoulder surgery.
It is the investigators hypothesis that the amount of morphine consumption in the first 4 hours postoperatively in the intervention group will be significant lower than in the placebo group.
- Conditions
- Pain, Postoperative
- Being tested
- ropivacaine, Sodium chloride
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
Also called Naropin
Single shot nerve block with ropivacaine 10-20 ml; 7,5 mg/ml
Sodium chlorideDrug
Single shot nerve block with isotonic sodiumchloride 10-20 ml; 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Sodium chloride Receives: Drug: Sodium chloride |
| ropivacaine | Active comparator | Naropin Receives: Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Patients are coupled to an intravenous PCA pump. The amount of morphine administered by the patient in the first 4 hours postoperatively is registered.
Measured: 0-4 hours postoperatively
Secondary outcomes (5)
Visual analogue scale (VAS) score
Postoperative VAS scores during the first 24 hours postoperatively, divided into two periods.
Measured: 0-12 hours and 12-24 hours postoperatively
Total morphine consumption
The total amount of morphine administered during the first 24 hours postoperatively
Measured: 0-24 hours postoperatively
Postoperative nausea and vomiting (PONV)
Postoperative nausea evaluated on a 1-3 scale with and without vomiting
Measured: 0-4, 0-12 and 12-24 hours postoperatively
Escape block
The use of an escape block (interscalene brachial plexus block) in patients with pain breakthrough despite IV morphine 0-4 hours postoperatively.
Measured: 0-4 hours postoperatively
Bolus morphine 5 mg iv
Number of morphine boli administered during the first 4 hours postoperatively
Measured: 0-4 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillerod Hospital, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Henrik Wiborg Lange, Hillerod Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463865
- Sponsor's protocol ID
- H-1-2011-057
- Status last verified
- Mar 2015
- First submitted
- 31 Oct 2011
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rothe C, Asghar S, Andersen HL, Christensen JK, Lange KH. Ultrasound-guided block of the axillary nerve: a volunteer study of a new method. Acta Anaesthesiol Scand. 2011 May;55(5):565-70. doi: 10.1111/j.1399-6576.2011.02420.x.
PubMed 21827442Rothe C, Lund J, Jenstrup MT, Steen-Hansen C, Lundstrom LH, Andreasen AM, Lange KHW. A randomized controlled trial evaluating the impact of selective axillary nerve block after arthroscopic subacromial decompression. BMC Anesthesiol. 2020 Jan 31;20(1):33. doi: 10.1186/s12871-020-0952-y.
PubMed 32005160
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Block of the Axillary Nerve in Postoperative Pain Management, a Randomised, Blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01463865
- Acronym / sponsor ID
- H-1-2011-057
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hillerod Hospital, DenmarkUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Nov 2011 (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.
In this study the investigators wish to compare the effect of a selective axillary nerve block to placebo in patients undergoing arthroscopic shoulder surgery.
It is the investigators hypothesis that the amount of morphine consumption in the first 4 hours postoperatively in the intervention group will be significant lower than in the placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Sodium chlorideSodium chloride |
| ropivacaine | Active comparator | Drug: ropivacaineNaropin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects undergoing arthroscopic shoulder surgery
- Age between 18 and 80 years
- ASA 1-3
- BMI between 18 and 35 kg/m2
- Subjects which have given their written informed consent
Key exclusion criteria (6 listed)
- Subjects unable to cooperate to the investigation
- Subjects not understanding or speaking danish
- Subjects allergic to intervention drugs
- Daily use of strong analgesics (morphine, oxycontine, ketogan)
- Alcohol or medicine misuse
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 |
|---|---|---|
| ropivacaineAlso: NaropinSingle shot nerve block with ropivacaine 10-20 ml; 7,5 mg/ml | Drug | ropivacaine |
| Sodium chlorideSingle shot nerve block with isotonic sodiumchloride 10-20 ml; 0.9% | Drug | Placebo |
Primary outcome
Morphine consumption
Time frame: 0-4 hours postoperatively
Patients are coupled to an intravenous PCA pump. The amount of morphine administered by the patient in the first 4 hours postoperatively is registered.
5 secondary outcomes
Visual analogue scale (VAS) score
Time frame: 0-12 hours and 12-24 hours postoperatively
Total morphine consumption
Time frame: 0-24 hours postoperatively
Postoperative nausea and vomiting (PONV)
Time frame: 0-4, 0-12 and 12-24 hours postoperatively
Escape block
Time frame: 0-4 hours postoperatively
Bolus morphine 5 mg iv
Time frame: 0-4 hours 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 20 Mar 2015.
- Background: PubMed 21827442Rothe C, Asghar S, Andersen HL, Christensen JK, Lange KH. Ultrasound-guided block of the axillary nerve: a volunteer study of a new method. Acta Anaesthesiol Scand. 2011 May;55(5):565-70. doi: 10.1111/j.1399-6576.2011.02420.x.
- Derived from this study: PubMed 32005160Rothe C, Lund J, Jenstrup MT, Steen-Hansen C, Lundstrom LH, Andreasen AM, Lange KHW. A randomized controlled trial evaluating the impact of selective axillary nerve block after arthroscopic subacromial decompression. BMC Anesthesiol. 2020 Jan 31;20(1):33. doi: 10.1186/s12871-020-0952-y.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Sodium chloride in people with Pain, Postoperative, run by Hillerod Hospital, Denmark 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 5 inclusion and 6 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 20 Mar 2015. 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. Some participants in this study may receive a placebo. 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?
Morphine consumption (time frame: 0-4 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 NCT01463865, which also lists 2 linked publications.
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 20 Mar 2015.