Shoulder PainPhase 4NCT02903719
The Effect of Phrenic Nerve Block on Postoperative Shoulder Pain in Patients for Liver Resection.
A Phase 4 study testing Ropivacaine in people with Shoulder Pain and Surgery, run by Eske Kvanner Aasvang at 1 site in Denmark.
Trial summary
The aim of this study is to explore whether the use of ultrasound guided phrenic nerve block can reduce the postoperative pain in the shoulder after liver resection. The intervention is directed postoperative to the patients experiencing novel right sided shoulder pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain, Surgery, Nerve Block
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to Apr 2017
- 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
- Age above 18.
- Patients scheduled for liver resection.
- Ability to give informed consent.
Who cannot join
- Participation in another clinical trial, dealing with pain or management of pain, which could affect this trial, evaluated by the investigator.
- Inability to talk and understand danish
- Drug or alcohol abuse
- Pregnancy
- Congestive heart failure (NYHA class III-IV), or other serious heart disease.
- Chronic obstructive lung disease, moderate or severe degree, or other significant lung disease
Show all 16Show fewer
- Chronic or acute shoulder pain prior to surgery.
- Body Mass Index above 35.
- Infection at the site of the injection
- Allergy to ropivacaine
- Postoperative:
- Shoulder pain score < 6 assessed on the numeric rating scale (0-10), 15 minutes after arrival in postanaesthetic care unit (PA CU).
- Insufficient epidural analgesia, or lack of epidural analgesia.
- Inability to visualize nervus phrenicus with sonography.
- Cerebral confusion, postoperative delirium or other medical condition hindering study intervention.
- Presence of an investigator with intervention competence is not available.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2200
Eske mr Aasvang, Md, PhD, 0045 26232076, eske.aas@gmail.com
Søren mr Bøgevig, MD
About this study
Official title: The Effect of Phrenic Nerve Block on Postoperative Shoulder Pain in Patients for Liver Resection - a Double Blinded Randomised Controlled Trial.
The aim of this study is to explore whether the use of ultrasound guided phrenic nerve block can reduce the postoperative pain in the shoulder after liver resection. The intervention is directed postoperative to the patients experiencing novel right sided shoulder pain.
Read the detailed description
Background:
Patients undergoing both laparoscopic and open hepatic surgery often experience shoulder pain in the postoperative period, mostly on the right side.
The mechanism behind referral of pain from surgical sites to the ipsilateral (same side) shoulder is not fully understood. It has been stated, that the sharing of cervical sensory roots, leads the brain to an interpretation that the pain as originating from the ipsilateral shoulder, when the phrenic nerve is stimulated.
The phrenic nerve provides both sensory and motor nerves to the diaphragm, and sensory fibers to parts of the pleura and peritoneum. Furthermore, one anatomical study indicate, that the phrenic nerve on the right side supply the liver capsule with thin sensory nerves. This could also, in part, explain the shoulder pain after liver surgery.
Studies assessing the effect of phrenic block on shoulder pain by surgically applied intrathoracic block of the phrenic nerve, have found a pain reduction, without significant side effects. There are no available studies on the effect of phrenic nerve block after hepatic surgery. Blocking the nerve intraoperatively, as described in thoracic surgery, is not possible during these operations.
Pilot study of the incidence: A recent survey at Rigshospitalet, Denmark, revealed, that 19 out of 60 patients undergoing various types of hepatic surgery, experienced moderate to severe right sided shoulder pain in the post operative care unit. The only semi-effective treatment, has been opioids (morphine), often leading to significant side effects (nausea, vomiting , dizziness) with a potential for an increase in postoperative morbidity. Furthermore, referred shoulder pain affects the respiratory capacity postoperatively.
The investigators have developed a method for applying ultrasound-guided block at the lateral side of the neck, directly at the phrenic nerve where it crosses over the scaleni anterior muscle. The block is done with low volume of local anesthetic (only 3 ml very close to the nerve) aiming to avoid affection of the brachial plexus.
The phrenic nerve block have been performed at right sided shoulder pain in the postoperative care unit with marked effect within a few minutes (small nerve with little perineural insulation).
Trial endpoints:
The idea of the study is to perform a precise, low volume, ultrasound guided nerve block in the patients who experience a severe right sided shoulder pain (NRS >5 on a 0-10 scale) after liver surgery and evaluate the effect of active substance vs. placebo
Furthermore the investigators wish to stablish an evaluation of the duration of the phrenic nerve block when it comes to pain intensity, incidence of referred shoulder pain after liver surgery, and need for opioid and to evaluate the effect of the block on the lung function.
The study results will be described in a primary publication regarding the primary outcome, and a secondary publication regarding the incidence of acute respiratory and ventilatory affection observed in the PACU in patients undergoing open liver resection.
- Conditions
- Shoulder Pain, Surgery, Nerve Block
- Being tested
- Ropivacaine
- Keywords
- Phrenic, Nerve block, Postoperative shoulder pain, Liver resection
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
All included patients with a right sided shoulder pain score on a numeric rating scale (NRS) equal to or above 6 and without postoperative exclusion criteria will have two (1st and 2nd intervention) ultrasound guided phrenic nerve blocks performed.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | 1. st intervention: A single ultrasound guided perineural injection of Ropivacaine 7,5 mg/ml, 3 ml
2. nd intervention (approx. 15 minutes after 1st intervention): A single ultrasound guided perineural injection of isotonic saline solution 9 mg/ml, 3 ml Receives: Drug: Ropivacaine |
| Group B | Other | 1. st Intervention: A single ultrasound guided perineural injection of isotonic saline solution 9 mg/ml, 3 ml
2. nd Intervention (approx. 15 minutes after 1st intervention):A single ultrasound guided perineural injection of Ropivacaine 7,5 mg/ml, 3 ml Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurements on a NRS (Numeric Rating Scale)
Patients are asked to rate the intensity of their shoulder pain (if any) according to NRS (Numeric Rating Scale) from 0-10 (0=no pain, 10=the worst pain imaginable). For patients receiving the intervention they are asked to rate the intensity of their pain 15 minutes after the 1st intervention.
Measured: 1 hour
Secondary outcomes (9)
Lung function assessed by Spirometry
Lung function evaluated with spirometry (FEV1, FVC og VC) just prior to
1st intervention (baseline), compared to lung function after 1st intervention or 2nd intervention. Patients receiving the interventions get their lung function measured 3 times after the interventions. Patients excluded postoperatively get their lung function measured once.
Measured: 1 day
Lung function assessed by arterial blood gas
Lung function evaluated with arterial blood gas (paO2, paCO2) just prior to 1st intervention (baseline), compared to lung function after 1st intervention or 2nd intervention. Lung function is also evaluated with arterial blood gas one hour after 2nd intervention.
Measured: 1 hour
Duration of surgery compared to shoulder pain
Duration of surgery compared to shoulder pain just prior to 1st intervention. The intensity of pain is measured according to NRS (0-10, 0=no pain, 10=worst pain imaginable).
Measured: 1 hour
Number of included patients with low pain score (NRS) after interventions.
Number of included patients with a pain score (NRS) between 0 and 3 after 1st intervention or 2nd intervention.
Measured: 1 hour and 15 minutes
Number of patients with respiratory affection
Number of included patients with respiratory affection, if defined as this in the medical chart.
Measured: 1 day
Number os patients treated with opioid
Number of included patients treated with opioid and the amount of used opioid in morphine equivalence.
Measured: 2 hours
Prevalence of respiratory and cardiovascular events amon included and excluded patients.
Prevalence of respiratory og cardiovascular events until discharge when defined as this in medical chart and prevalence of readmission obtained from the Danish National Hospital Registry.
Measured: 30 days
Pain measurements 24 hours after the 1st intervention.
Patients are asked to rate the intensity of their shoulder pain according to NRS (numeric rating scale 0-10) 24 hours after the 1st intervention.
Measured: 24 hours
Pain measurements on a NRS (Numeric Rating Scale)
Patients are asked to rate the intensity of their shoulder pain (if any) according to NRS (Numeric rating scale) from 0-10 (0=no pain, 10=the worst pain imaginable). For patients receiving the intervention they are asked to rate the intensity of their pain +2, +5, +10 and +60 minutes after the 1st intervention and +2, +5, +10 and +15 after the 2nd intervention.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eske Kvanner Aasvang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903719
- Sponsor's protocol ID
- 13001
- Status last verified
- Sep 2016
- First submitted
- 13 Sep 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Phrenic Nerve Block on Postoperative Shoulder Pain in Patients for Liver Resection - a Double Blinded Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT02903719
- Acronym / sponsor ID
- 13001
- Conditions
- Shoulder Pain, Surgery, Nerve Block
- Keywords
- Phrenic, Nerve block, Postoperative shoulder pain, Liver resection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Eske Kvanner AasvangUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 16 Sep 2016 (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 aim of this study is to explore whether the use of ultrasound guided phrenic nerve block can reduce the postoperative pain in the shoulder after liver resection. The intervention is directed postoperative to the patients experiencing novel right sided shoulder pain.
Detailed description
Background:
Patients undergoing both laparoscopic and open hepatic surgery often experience shoulder pain in the postoperative period, mostly on the right side.
The mechanism behind referral of pain from surgical sites to the ipsilateral (same side) shoulder is not fully understood. It has been stated, that the sharing of cervical sensory roots, leads the brain to an interpretation that the pain as originating from the ipsilateral shoulder, when the phrenic nerve is stimulated.
The phrenic nerve provides both sensory and motor nerves to the diaphragm, and sensory fibers to parts of the pleura and peritoneum. Furthermore, one anatomical study indicate, that the phrenic nerve on the right side supply the liver capsule with thin sensory nerves. This could also, in part, explain the shoulder pain after liver surgery.
Studies assessing the effect of phrenic block on shoulder pain by surgically applied intrathoracic block of the phrenic nerve, have found a pain reduction, without significant side effects. There are no available studies on the effect of phrenic nerve block after hepatic surgery. Blocking the nerve intraoperatively, as described in thoracic surgery, is not possible during these operations.
Pilot study of the incidence: A recent survey at Rigshospitalet, Denmark, revealed, that 19 out of 60 patients undergoing various types of hepatic surgery, experienced moderate to severe right sided shoulder pain in the post operative care unit. The only semi-effective treatment, has been opioids (morphine), often leading to significant side effects (nausea, vomiting , dizziness) with a potential for an increase in postoperative morbidity. Furthermore, referred shoulder pain affects the respiratory capacity postoperatively.
The investigators have developed a method for applying ultrasound-guided block at the lateral side of the neck, directly at the phrenic nerve where it crosses over the scaleni anterior muscle. The block is done with low volume of local anesthetic (only 3 ml very close to the nerve) aiming to avoid affection of the brachial plexus.
The phrenic nerve block have been performed at right sided shoulder pain in the postoperative care unit with marked effect within a few minutes (small nerve with little perineural insulation).
Trial endpoints:
The idea of the study is to perform a precise, low volume, ultrasound guided nerve block in the patients who experience a severe right sided shoulder pain (NRS >5 on a 0-10 scale) after liver surgery and evaluate the effect of active substance vs. placebo
Furthermore the investigators wish to stablish an evaluation of the duration of the phrenic nerve block when it comes to pain intensity, incidence of referred shoulder pain after liver surgery, and need for opioid and to evaluate the effect of the block on the lung function.
The study results will be described in a primary publication regarding the primary outcome, and a secondary publication regarding the incidence of acute respiratory and ventilatory affection observed in the PACU in patients undergoing open liver resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Drug: Ropivacaine1. st intervention: A single ultrasound guided perineural injection of Ropivacaine 7,5 mg/ml, 3 ml 2. nd intervention (approx. 15 minutes after 1st intervention): A single ultrasound guided perineural injection of isotonic saline solution 9 mg/ml, 3 ml |
| Group B | Other | Drug: Ropivacaine1. st Intervention: A single ultrasound guided perineural injection of isotonic saline solution 9 mg/ml, 3 ml 2. nd Intervention (approx. 15 minutes after 1st intervention):A single ultrasound guided perineural injection of Ropivacaine 7,5 mg/ml, 3 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 18.
- Patients scheduled for liver resection.
- Ability to give informed consent.
Key exclusion criteria (16 listed)
- Participation in another clinical trial, dealing with pain or management of pain, which could affect this trial, evaluated by the investigator.
- Inability to talk and understand danish
- Drug or alcohol abuse
- Pregnancy
- Congestive heart failure (NYHA class III-IV), or other serious heart disease.
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: NaropinAll included patients with a right sided shoulder pain score on a numeric rating scale (NRS) equal to or above 6 and without postoperative exclusion criteria will have two (1st and 2nd intervention) ultrasound guided phrenic nerve blocks performed. | Drug | Group A, Group B |
Primary outcome
Pain measurements on a NRS (Numeric Rating Scale)
Time frame: 1 hour
Patients are asked to rate the intensity of their shoulder pain (if any) according to NRS (Numeric Rating Scale) from 0-10 (0=no pain, 10=the worst pain imaginable). For patients receiving the intervention they are asked to rate the intensity of their pain 15 minutes after the 1st intervention.
9 secondary outcomes
Lung function assessed by Spirometry
Time frame: 1 day
Lung function assessed by arterial blood gas
Time frame: 1 hour
Duration of surgery compared to shoulder pain
Time frame: 1 hour
Number of included patients with low pain score (NRS) after interventions.
Time frame: 1 hour and 15 minutes
Number of patients with respiratory affection
Time frame: 1 day
Number os patients treated with opioid
Time frame: 2 hours
Prevalence of respiratory and cardiovascular events amon included and excluded patients.
Time frame: 30 days
Pain measurements 24 hours after the 1st intervention.
Time frame: 24 hours
Pain measurements on a NRS (Numeric Rating Scale)
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- 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.
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 Ropivacaine in people with Shoulder Pain and Surgery, run by Eske Kvanner Aasvang 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 3 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 23 Sep 2016. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Søren Mr Bøgevig, MD (0045 20 66 40 51, soeren.boegevig.03@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measurements on a NRS (Numeric Rating Scale) (time frame: 1 hour). 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 23 Sep 2016.