Muscle InjuryNCT04170101
RCT Deep vs Moderat NMB on Surgical Conditions During THP
A study testing deep NMB and moderate NMB in people with Muscle Injury, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
A clinical deep NMB might relax the anterior muscles of the upper leg better than a moderate/superficial block giving a better exposure for the surgeon with less muscle trauma by traction to expose the hip. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Injury
- What is being tested?
- deep NMB and moderate NMB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2021to 30 Jun 2022
- 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
- • Hip arthroplasty by anterior approach using Minimally Invasive Surgery
Who cannot join
- • Revision arthroplasty.
- Allergy or contra indications to use any of the drugs included in anesthesia.
- Addiction to or chronic opioid use before surgery.
- Major cardiovascular, pulmonary, liver or renal insufficiency before surgery requiring possible post-operative intensive care admission.
- Contra indication for a general anesthesia with intubation and mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
Jan VanLommel, MD contact
About this study
Official title: Randomized Controlled Trial Comparing the Impact of Deep Versus Moderate/Superficial NMB on Surgical Conditions and Muscle Trauma During Hip Arthroplasty by Direct Anterior Approach Using Minimally Invasive Surgery.
A clinical deep NMB might relax the anterior muscles of the upper leg better than a moderate/superficial block giving a better exposure for the surgeon with less muscle trauma by traction to expose the hip.
a continuous deep NMB (group A) versus a non deep NMB (group B) having a moderate to superficial block imitating common practice today as control group.
Primary objectives are surgical exposure and Secondary objectives are Muscle damage creatine kinase changes, C-reactive protein (CRP), first time leaving bed postoperative, post operative pain as measured by opioid use postoperative at 24h, with a control of max VAS score during first 24 hour, length of hospital stay (LOS), number of adverse events using the Dindo-Clavien surgical complication score, QoR15 measured at 24h on the ward.
Read the detailed description
In this study, CRP levels are choosen as it is measured standard in every total hip arthroplasty (THA) procedure. CK is a good biomarker for muscle trauma and therefore chosen as second marker.
The study is blinded for the treating surgeon, who will be making the assessment for the surgical conditions. The attending anesthesiologist is not blinded as he has to measure NMB in both groups and give a rocuronium infusion to stay deep in the study group. The anesthesiologist and the nurses following the patient on the post anesthetic care unit (PACU) and the ward are different from the attending anesthesiologist and are blinded. They will not be informed by the attending anesthesiologist on randomization allocation.
Randomization:
Group A deep NMB group:
- 0,6 mg/kg LBW Rocuronium is used to facilitate intubation, and followed by an infusion of 1 mg/kg LBW/h , further adapted to keep post tetanic count (PTC) < 3 without informing the surgeon of the depth (surgeon is blinded)
Group B moderate to superficial NMB group:
- 0,6 mg/kg LBW rocuronium is used to facilitate intubation, not followed by an infusion or extra bolus.train of four ( TOF) and PTC are measured at the beginning of surgery without informing the surgeon of the depth. (surgeon is blinded) 2 weeks before surgery at consultation of orthopedics and anesthesia:
- Inclusion criteria, signing informed consent, CRP blood sample
- 15 Quality of recovery questions (QoR15) filled in to have a pre op status
Day before surgery:
- Verification that study can be performed ( equipment, surgeon, anesthesiologist and investigators available) Morning of surgery
- Control signing of informed consent is done and patient still willing to continue the study
- Attending anesthesiologist ask the randomization allocation at the secretary anesthesia without informing surgeon, colleagues and nurses on PACU and ward.
Anesthesia \& surgery performed
- CRF is filled in with time stamps, dosing of drugs and monitoring values
- Surgeon is asked for a surgical exposure grading ( 1-5) after initial incision, at the critical moment of prosthesis insertion and before closure.
- In order to measure the degree of muscle damage, one light photo is taken of the muscles before closing and archived for later anonymous scoring by an independent orthopedic surgeon doing also THA by DAA but not around that day in the OR (3 surgeons do frequently THA by DAA).
- If an opioid is given before PACU admission dose and time are noted in the clinical registration file (CRF) PACU
- VAS score is recorded on admission, every hour and before leaving PACU.
- The total dose of opioids given during the PACU are noted in the CRF Ward
- Max visual analog pain score (VAS) during first 24 hours on the ward is noted in the CRF.
- The QoR15 is repeated at 24 hours post surgery
- A CRP blood sample is taken 24 hours post surgery
- The total dose of opioids given on the ward till discharge is noted in the CRF
Home
- 2 weeks after surgery a phone call is given to request healthy state
- and hear of any adverse event or complication.
- and repeat the QoR15 questionnaire by phone
- Conditions
- Muscle Injury
- Being tested
- deep NMB, moderate NMB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep NMBProcedure or surgery
0,6 mg/kg LBW Rocuronium is used to facilitate intubation, and followed by an infusion of 1 mg/kg LBW/h , further adapted to keep PTC < 3
moderate NMBProcedure or surgery
0,6 mg/kg LBW rocuronium is used to facilitate intubation, not followed by an infusion or extra bolus.
| Study group | Role | What they receive |
|---|---|---|
| a continuous deep NMB (group A) | Experimental | after 0,6 mg/kg LBW Rocuronium for intubation Rocuronium is given in a continuous infusion starting at 1 mg/kg/h and adapted to keep PTC below 5 and note. Receives: Procedure: deep NMB |
| non deep NMB (group B) | Placebo comparator | after 0,6 mg/kg LBW Rocuronium for intubation no extra NMB is given and depth is measured by TOF/PTC to note depth. Receives: Procedure: moderate NMB |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical exposure
After the surgical procedure the surgeon will be asked to score the surgical conditions on an adapted five point Leiden scale (validated scale):
max = 5 and best; min = 1 and worst grade 5: optimal surgical conditions, perfect access to the hip joint and excellent visibility.
grade 4: good conditions: adequate surgical conditions to perform the surgery, but not optimal grade 3: just acceptable conditions, surgical procedure is jeopardized, but adequate surgical result is still obtained, eventually after additional intervention grade 2: poor conditions, exposure and handling hindered resulting in suboptimal surgical outcome requiring adaptation of procedure or interventions to improve condition.
grade 1: extremely poor conditions, the surgeon is unable to work because of the inability to get access to the hip joint because of inadequate muscle relaxation and request to improve conditions first before continuing.
Measured: from incision till end of surgery stop at day zero
Secondary outcomes (7)
muscle injury
This is scored on an adapted five point scale post surgery on a light photo taken at end of surgery before closing, by an orthopedic surgeon not around during surgery.
max = 5 and best; min = 1 and worst
grade 1: muscle severely damaged with open cuts; grade 2: muscle damaged with free tears; grade 3: muscle superficial damaged and swollen; grade 4: muscle intact, but swollen or perfusion not optimal grade 5: muscle intact without swelling and normal perfused.
Measured: on photo after procedure stop at day zero
creatinine kinase (CK)
creatinine kinase (CK) changes as a measure for muscle trauma, at 24 hours postoperative versus baseline
Measured: 24 hours after surgery stop at day 1
C-reactive protein (CRP)
C-reactive protein (CRP) changes as a measure for inflammation, at 24 hours postoperative versus baseline.
Measured: 24 hours after surgery stop at day 1
leaving bed
First time leaving bed postoperative
Measured: within 24 hours postoperative stop at day 1
Length of stay
Length of hospital stay (LOS)
Measured: measured in days up to one week post surgery stop at day 7
postoperative complications
Number of adverse events using the Dindo-Clavien surgical complication score
Measured: up to two weeks postoperative stop at day 14
quality of recovery
15 Quality of recovery questions (QoR15) measured at 24h on the ward and at 2 weeks post operative max: 150: best; min: 0: worst each question is answered on a scale from 0 to 10.
Measured: 2 weeks postoperative stop at day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Apr 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a continuous deep NMB (group A) versus a non deep NMB (group B) having a moderate to superficial block imitating common practice today as control group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Mulier, AZ Sint-Jan AV
- Investigators
- jan mulier, Principal investigator, AZSint Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170101
- Sponsor's protocol ID
- 2019RCTdeepNMBTHP
- Status last verified
- Mar 2020
- First submitted
- 16 Nov 2019
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Impact of Deep Versus Moderate/Superficial NMB on Surgical Conditions and Muscle Trauma During Hip Arthroplasty by Direct Anterior Approach Using Minimally Invasive Surgery.
- ClinicalTrials.gov ID
- NCT04170101
- Acronym / sponsor ID
- 2019RCTdeepNMBTHP
- Conditions
- Muscle Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 20 Nov 2019 (actual)
- 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.
A clinical deep NMB might relax the anterior muscles of the upper leg better than a moderate/superficial block giving a better exposure for the surgeon with less muscle trauma by traction to expose the hip.
a continuous deep NMB (group A) versus a non deep NMB (group B) having a moderate to superficial block imitating common practice today as control group.
Primary objectives are surgical exposure and Secondary objectives are Muscle damage creatine kinase changes, C-reactive protein (CRP), first time leaving bed postoperative, post operative pain as measured by opioid use postoperative at 24h, with a control of max VAS score during first 24 hour, length of hospital stay (LOS), number of adverse events using the Dindo-Clavien surgical complication score, QoR15 measured at 24h on the ward.
Detailed description
In this study, CRP levels are choosen as it is measured standard in every total hip arthroplasty (THA) procedure. CK is a good biomarker for muscle trauma and therefore chosen as second marker.
The study is blinded for the treating surgeon, who will be making the assessment for the surgical conditions. The attending anesthesiologist is not blinded as he has to measure NMB in both groups and give a rocuronium infusion to stay deep in the study group. The anesthesiologist and the nurses following the patient on the post anesthetic care unit (PACU) and the ward are different from the attending anesthesiologist and are blinded. They will not be informed by the attending anesthesiologist on randomization allocation.
Randomization:
Group A deep NMB group:
- 0,6 mg/kg LBW Rocuronium is used to facilitate intubation, and followed by an infusion of 1 mg/kg LBW/h , further adapted to keep post tetanic count (PTC) < 3 without informing the surgeon of the depth (surgeon is blinded)
Group B moderate to superficial NMB group:
- 0,6 mg/kg LBW rocuronium is used to facilitate intubation, not followed by an infusion or extra bolus.train of four ( TOF) and PTC are measured at the beginning of surgery without informing the surgeon of the depth. (surgeon is blinded) 2 weeks before surgery at consultation of orthopedics and anesthesia:
- Inclusion criteria, signing informed consent, CRP blood sample
- 15 Quality of recovery questions (QoR15) filled in to have a pre op status
Day before surgery:
- Verification that study can be performed ( equipment, surgeon, anesthesiologist and investigators available) Morning of surgery
- Control signing of informed consent is done and patient still willing to continue the study
- Attending anesthesiologist ask the randomization allocation at the secretary anesthesia without informing surgeon, colleagues and nurses on PACU and ward.
Anesthesia \& surgery performed
- CRF is filled in with time stamps, dosing of drugs and monitoring values
- Surgeon is asked for a surgical exposure grading ( 1-5) after initial incision, at the critical moment of prosthesis insertion and before closure.
- In order to measure the degree of muscle damage, one light photo is taken of the muscles before closing and archived for later anonymous scoring by an independent orthopedic surgeon doing also THA by DAA but not around that day in the OR (3 surgeons do frequently THA by DAA).
- If an opioid is given before PACU admission dose and time are noted in the clinical registration file (CRF) PACU
- VAS score is recorded on admission, every hour and before leaving PACU.
- The total dose of opioids given during the PACU are noted in the CRF Ward
- Max visual analog pain score (VAS) during first 24 hours on the ward is noted in the CRF.
- The QoR15 is repeated at 24 hours post surgery
- A CRP blood sample is taken 24 hours post surgery
- The total dose of opioids given on the ward till discharge is noted in the CRF
Home
- 2 weeks after surgery a phone call is given to request healthy state
- and hear of any adverse event or complication.
- and repeat the QoR15 questionnaire by phone
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- a continuous deep NMB (group A) versus a non deep NMB (group B) having a moderate to superficial block imitating common practice today as control group.
| Arm | Type | Receives |
|---|---|---|
| a continuous deep NMB (group A) | Experimental | Procedure: deep NMBafter 0,6 mg/kg LBW Rocuronium for intubation Rocuronium is given in a continuous infusion starting at 1 mg/kg/h and adapted to keep PTC below 5 and note. |
| non deep NMB (group B) | Placebo comparator | Procedure: moderate NMBafter 0,6 mg/kg LBW Rocuronium for intubation no extra NMB is given and depth is measured by TOF/PTC to note depth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Hip arthroplasty by anterior approach using Minimally Invasive Surgery
Key exclusion criteria (5 listed)
- • Revision arthroplasty.
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 |
|---|---|---|
| deep NMB0,6 mg/kg LBW Rocuronium is used to facilitate intubation, and followed by an infusion of 1 mg/kg LBW/h , further adapted to keep PTC < 3 | Procedure or surgery | a continuous deep NMB (group A) |
| moderate NMB0,6 mg/kg LBW rocuronium is used to facilitate intubation, not followed by an infusion or extra bolus. | Procedure or surgery | non deep NMB (group B) |
Primary outcome
surgical exposure
Time frame: from incision till end of surgery stop at day zero
After the surgical procedure the surgeon will be asked to score the surgical conditions on an adapted five point Leiden scale (validated scale): max = 5 and best; min = 1 and worst grade 5: optimal surgical conditions, perfect access to the hip joint and excellent visibility. grade 4: good conditions: adequate surgical conditions to perform the surgery, but not optimal grade 3: just acceptable conditions, surgical procedure is jeopardized, but adequate surgical result is still obtained, eventually after additional intervention grade 2: poor conditions, exposure and handling hindered resulting in suboptimal surgical outcome requiring adaptation of procedure or interventions to improve condition. grade 1: extremely poor conditions, the surgeon is unable to work because of the inability to get access to the hip joint because of inadequate muscle relaxation and request to improve conditions first before continuing.
7 secondary outcomes
muscle injury
Time frame: on photo after procedure stop at day zero
creatinine kinase (CK)
Time frame: 24 hours after surgery stop at day 1
C-reactive protein (CRP)
Time frame: 24 hours after surgery stop at day 1
leaving bed
Time frame: within 24 hours postoperative stop at day 1
Length of stay
Time frame: measured in days up to one week post surgery stop at day 7
postoperative complications
Time frame: up to two weeks postoperative stop at day 14
quality of recovery
Time frame: 2 weeks postoperative stop at day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Jan VanLommel, MD contact
jan mulier principal investigator
AZSint Jan AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep NMB and moderate NMB in people with Muscle Injury, run by AZ Sint-Jan AV at 1 site in Belgium.
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 5 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 20 Jan 2021. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Paul Mulier, MD PhD (+3250452490, jan.mulier@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical exposure (time frame: from incision till end of surgery stop at day zero). 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 20 Jan 2021.