PainNCT02576223
Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery
A study testing Ropivacaine hydrochloride, Isotonic Saline and PCA-pump in people with Pain, run by Kai Henrik Wiborg Lange at 2 sites in Denmark.
Trial summary
The purpose of this randomized study is to examine the effect of a selective suprascapular nerve block on post operative pain after arthroscopic shoulder surgery. Half of the subjects will receive a active nerve block with Ropivacain. Half of the subjects will receive a placebo nerve block with saline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Ropivacaine hydrochloride, Isotonic Saline and PCA-pump
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesDenmark
- Study dates
- Oct 2015to 27 Aug 2018
- 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
- Patients planned for arthroscopic shoulder surgery.
- Age ≥ 18.
- ASA class ≤ 3.
Who cannot join
- Patients with VAS never ≥5 mm during the first hour after arrivel to the post anesthesia care unit.
- Patients unable to cooperate.
- Patients unable to understand or speak danish.
- Allergy towards the used drugs.
- Abuse of alcohol- and/or medicine - investigators assessment.
- Usage of opioids on a daily basis (not including Tramadole).
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- Pregnancy (It is obligatory for all fertile women in the study to take a hcg urine test).
- Operations involving the clavicle.
- Operations converted to open surgery.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Nordsjællands Hospital
Hillerød, 3400
Holbæk Sygehus
Holbæk, 4300
About this study
Official title: Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery - a Randomized, Blinded, Placebo Controlled Study
The purpose of this randomized study is to examine the effect of a selective suprascapular nerve block on post operative pain after arthroscopic shoulder surgery. Half of the subjects will receive a active nerve block with Ropivacain. Half of the subjects will receive a placebo nerve block with saline.
Read the detailed description
Postoperative pain management after arthroscopic shoulder surgery traditionally includes opioids and/or an interscalene brachial plexus block(IBPB). Opioid consumption often leads to unpleasant side effects including nausea, vomitting and sedation. IBPB offers very efficient pain relief but includes the discomfort of a paralyzed arm. Furthermore this approach often also leads to unilateral paresis of the phrenic nerve causing reduced respiratory capacity. The latter offering discomfort and a potential risk in patients with lung diseases or heavy overweight.
The suprascapular nerve is the most important nerve to the shoulder and a selective block of this nerve could offer a good pain relief without the mentioned side effects.
In this randomized study the investigators wish to examine the pain relieving effect of a selective block of the suprascapular nerve after arthroscopic shoulder surgery.
40 patients are randomized to a block of this nerve with either active drug (Ropivacaine) or placebo (Saline). All patients will get a PCA (Patient Controlled Analgesia) pump for administration of i.v. morphine in doses based on age and weight.
Patient are being monitored for 6 hours. The primary outcome is reduction in VAS at rest from baseline to 30 minutes after nerve block.
- Conditions
- Pain
- Being tested
- Ropivacaine hydrochloride, Isotonic Saline, PCA-pump
- Keywords
- Peripheral Nerve Blocks
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine hydrochlorideDrug
Also called Ropivacaine, Naropin
Ropivacaine injected perineural at the suprascapular nerve.
Isotonic SalineDrug
Also called Saline
Saline injected perineural at the suprascapular nerve.
PCA-pumpDrug
Also called Morphine
PCA (Patient controlled analgesia) pump with the following settings:
Age > 70 years or weight < 60 kg: bolus dose 2,5 mg i.v. morphine, 15 minutes lockout Age < 70 years and weight > 60 kg: bolus dose 5 mg i.v. morphine, 15 minutes lockout Lockout time 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine hydrochloride | Active comparator | Ropivacain 7.5mg/ml, 5 ml injected perineural at the suprascapular nerve. Receives: Drug: Ropivacaine hydrochloride; Drug: PCA-pump |
| Isotonic Saline | Placebo comparator | 0.9% Saline solution, 5 ml injected perineural at the suprascapular nerve. Receives: Drug: Isotonic Saline; Drug: PCA-pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS) score at rest at T½
Change in VAS score at rest from baseline to 30 minutes after nerve block (T½).
Measured: Baseline to 30 minutes
Secondary outcomes (5)
VAS score during maximum active shoulder abduction from T½ to T6
VAS scores measured at 7 timepoints (T½, T1, T2, T3, T4, T5, T6) during maximal active shoulder abduction and calculated as area under the curve (AUC).
Measured: ½, 1, 2, 3, 4, 5, 6 hours
VAS score at rest from T½ to T6
VAS scores measured at 7 timepoints (T½, T1, T2, T3, T4, T5, T6) at rest and calculated as area under the curve (AUC).
Measured: ½, 1, 2, 3, 4, 5, 6 hours
Morphine consumption.
The total amount of morphine administered via the intravenous PCA pump the first 6 hours after nerve block.
Measured: 6 hours
Electromyography at T½
Change in activity of the infraspinatus muscle measured with surface electromyography from baseline to T½.
Measured: Baseline to 30 minutes
Muscle strength at T½
Change in strength of the supraspinatus (abduction of the shoulder) and the infraspinatus muscle (external rotation of the shoulder) measured with a handheld dynamometer from baseline to T½.
Measured: Baseline to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kai Henrik Wiborg Lange
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kai Henrik Wiborg Lange, Hillerod Hospital, Denmark
- Investigators
- Christian Steen-Hansen, Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576223
- Sponsor's protocol ID
- H-15008712
- Other IDs
- 2015-002391-24, 2015
- Status last verified
- Mar 2024
- First submitted
- 13 Oct 2015
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery - a Randomized, Blinded, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02576223
- Acronym / sponsor ID
- H-15008712
- Conditions
- Pain
- Keywords
- Peripheral Nerve Blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kai Henrik Wiborg LangeUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 15 Oct 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.
The purpose of this randomized study is to examine the effect of a selective suprascapular nerve block on post operative pain after arthroscopic shoulder surgery. Half of the subjects will receive a active nerve block with Ropivacain. Half of the subjects will receive a placebo nerve block with saline.
Detailed description
Postoperative pain management after arthroscopic shoulder surgery traditionally includes opioids and/or an interscalene brachial plexus block(IBPB). Opioid consumption often leads to unpleasant side effects including nausea, vomitting and sedation. IBPB offers very efficient pain relief but includes the discomfort of a paralyzed arm. Furthermore this approach often also leads to unilateral paresis of the phrenic nerve causing reduced respiratory capacity. The latter offering discomfort and a potential risk in patients with lung diseases or heavy overweight.
The suprascapular nerve is the most important nerve to the shoulder and a selective block of this nerve could offer a good pain relief without the mentioned side effects.
In this randomized study the investigators wish to examine the pain relieving effect of a selective block of the suprascapular nerve after arthroscopic shoulder surgery.
40 patients are randomized to a block of this nerve with either active drug (Ropivacaine) or placebo (Saline). All patients will get a PCA (Patient Controlled Analgesia) pump for administration of i.v. morphine in doses based on age and weight.
Patient are being monitored for 6 hours. The primary outcome is reduction in VAS at rest from baseline to 30 minutes after nerve block.
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 |
|---|---|---|
| Ropivacaine hydrochloride | Active comparator | Drug: Ropivacaine hydrochloride, Drug: PCA-pumpRopivacain 7.5mg/ml, 5 ml injected perineural at the suprascapular nerve. |
| Isotonic Saline | Placebo comparator | Drug: Isotonic Saline, Drug: PCA-pump0.9% Saline solution, 5 ml injected perineural at the suprascapular nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients planned for arthroscopic shoulder surgery.
- Age ≥ 18.
- ASA class ≤ 3.
Key exclusion criteria (9 listed)
- Patients with VAS never ≥5 mm during the first hour after arrivel to the post anesthesia care unit.
- Patients unable to cooperate.
- Patients unable to understand or speak danish.
- Allergy towards the used drugs.
- Abuse of alcohol- and/or medicine - investigators assessment.
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 hydrochlorideAlso: Ropivacaine, NaropinRopivacaine injected perineural at the suprascapular nerve. | Drug | Ropivacaine hydrochloride |
| Isotonic SalineAlso: SalineSaline injected perineural at the suprascapular nerve. | Drug | Isotonic Saline |
| PCA-pumpAlso: MorphinePCA (Patient controlled analgesia) pump with the following settings: Age > 70 years or weight < 60 kg: bolus dose 2,5 mg i.v. morphine, 15 minutes lockout Age < 70 years and weight > 60 kg: bolus dose 5 mg i.v. morphine, 15 minutes lockout Lockout time 15 minutes. | Drug | Isotonic Saline, Ropivacaine hydrochloride |
Primary outcome
Visual analogue scale (VAS) score at rest at T½
Time frame: Baseline to 30 minutes
Change in VAS score at rest from baseline to 30 minutes after nerve block (T½).
5 secondary outcomes
VAS score during maximum active shoulder abduction from T½ to T6
Time frame: ½, 1, 2, 3, 4, 5, 6 hours
VAS score at rest from T½ to T6
Time frame: ½, 1, 2, 3, 4, 5, 6 hours
Morphine consumption.
Time frame: 6 hours
Electromyography at T½
Time frame: Baseline to 30 minutes
Muscle strength at T½
Time frame: Baseline to 30 minutes
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 Mar 2024.
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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.
Christian Steen-Hansen principal investigator
Nordsjaellands Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine hydrochloride, Isotonic Saline and PCA-pump in people with Pain, run by Kai Henrik Wiborg Lange at 2 sites 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 3 inclusion and 9 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 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Visual analogue scale (VAS) score at rest at T½ (time frame: Baseline to 30 minutes). 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 Mar 2024.