SurgeryPhase 4NCT03369782
Effect of NMBA on Surgical Conditions in THR
A Phase 4 study testing Rocuronium and Sugammadex in people with Surgery and Postoperative Pain, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial summary
During Total hip replacement arthroplasty (THA), the hip joint first must be luxated in order to have access to the joints. A lot of force and torque must be carried out on the joint to perform this manipulation. This is both difficult for the surgeon and may cause additional tissue damage and postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Surgery, Postoperative Pain
- What is being tested?
- Rocuronium and Sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Dec 2017to 31 May 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed informed consent
- eligible for primary THA
- BMI <35
Who cannot join
- neurological or psychiatric disorders
- intolerance or allergy against investigational drugs or any of the drugs used in the standardized analgetics scheme (acetaminophen, diclofenac, ketamine, clonidine, lidocaine)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Neuromuscular Blockade on Surgical Conditions and Patient Reported Comfort Scores in Total Hip Replacement Arthroplasty
During Total hip replacement arthroplasty (THA), the hip joint first must be luxated in order to have access to the joints. A lot of force and torque must be carried out on the joint to perform this manipulation. This is both difficult for the surgeon and may cause additional tissue damage and postoperative pain. After placement of the prosthesis and reduction of the joint, the tension of the hip joint must be evaluated by the surgeon to ascertain the adequacy of the prosthesis. During luxation, minimal muscle tension would be ideal, while after reduction of the joint, normal muscle tension is desired to permit assessment of the mechanics of the hip joint.
The aim of the study is to investigate whether deep neuromuscular block, combined with a reversal before mechanics assessment improves surgical conditions, surgical time, and postoperative patient comfort.
Read the detailed description
2X20 patients are randomised: Rocuronium-group (R-group) and Placebo-group (P-group).
All patients receive standardised multimodal intravenous analgesia. After standardised induction of anasthesia and patient positioning, the patient is administered either placebo or rocuronium 0.9 mg/kg, followed by continuous infusion of either placebo or rocuronium 0.4 mg/kg/h. 1 minute before reduction of the hip joint, the patient is administered either sugammadex (R-group) or placebo (P-group) for full reversal of the neuromuscular block.
During the surgery, time points are recorded for: incision, start luxation of the joint, start reduction of the joint, start skin closure.
The surgeon is blinded for patient allocation. At three moments (after luxation, just before reduction of the joint, and after assessment of joint mechanics), the surgeon is asked to appraise the surgical conditions on an analogue scale.
Postoperative analgesic consumption and pain scores are recorded. VAS scores for knee pain and hip pain are assessed before surgery, at the moment of discharge from the post-anesthesia care unit (=D0), the morning after surgery (=D1), at D2, and at D7.
- Conditions
- Surgery, Postoperative Pain
- Being tested
- Rocuronium, Sugammadex, Placebo
- Keywords
- Muscle Tension, Skeletal Muscle Relaxants, Arthroplasties, Hip Replacement, Rocuronium, sugammadex
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called Esmeron
rocuronium is administered in bolus and continuous infusion
SugammadexDrug
Also called Bridion
Sugammadex is administered just before reduction of the joint
PlaceboDrug
Also called Saline 0.9%
Placebo is administered as alternative to rocuronium in a bolus and in a syringe pump.
Placebo is administered as alternative to sugammadex
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo alternative for rocuronium and for sugammadex Receives: Drug: Placebo |
| Rocuronium | Active comparator | Rocuronium as bolus and in syringe pump Sugammadex just before reduction of the joint Receives: Drug: Rocuronium; Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical conditions during luxation on a four-grade numeric scale
Excellent - good but not optimal - poor but acceptable - unacceptable
Measured: during surgery, during luxation of the joint
Secondary outcomes (4)
Patient reported pain scores on a VAS score (0-100 ; 0=no pain , 100=worst pain)
Patient reported pain scores in knee and hip after surgery at day 0-1-2-7
Measured: day 0-1-2-7 (day 0 = day of surgery)
surgery time
time (in minutes) of surgery between incision and reduction, and between reduction and skin closure
Measured: during surgery
Surgical conditions during reduction of the joint on a four-grade numeric scale
Excellent - good but not optimal - poor but acceptable - unacceptable
Measured: during surgery, during reduction of the joint
Surgical conditions for assessment of joint kinetics on a four-grade numeric scale
Excellent - good but not optimal - poor but acceptable - unacceptable
Measured: during surgery, after reduction of the joint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start15 Dec 2017 (estimated)
- Primary completion30 Apr 2018 (estimated)
- Study completion31 May 2018 (estimated)
Why it stopped: refocusing of research priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Parallel groups
- Model description
- Group A receives rocuronium, followed by sugammadex. Group B receives placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alain Kalmar, MD, PhD, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Alain F Kalmar, MD, PhD, MSc, Principal investigator, Maria Middelares Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369782
- Sponsor's protocol ID
- MMS.2017.033
- Status last verified
- Mar 2019
- First submitted
- 4 Dec 2017
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: scores of surgical conditions patient-reported pain scores data about surgery time
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Blockade on Surgical Conditions and Patient Reported Comfort Scores in Total Hip Replacement Arthroplasty
- ClinicalTrials.gov ID
- NCT03369782
- Acronym / sponsor ID
- MMS.2017.033
- Conditions
- Surgery, Postoperative Pain
- Keywords
- Muscle Tension, Skeletal Muscle Relaxants, Arthroplasties, Hip Replacement, Rocuronium, sugammadex
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: refocusing of research priorities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 15 Dec 2017 (estimated)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 31 May 2018 (estimated)
- First posted
- 12 Dec 2017 (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.
During Total hip replacement arthroplasty (THA), the hip joint first must be luxated in order to have access to the joints. A lot of force and torque must be carried out on the joint to perform this manipulation. This is both difficult for the surgeon and may cause additional tissue damage and postoperative pain. After placement of the prosthesis and reduction of the joint, the tension of the hip joint must be evaluated by the surgeon to ascertain the adequacy of the prosthesis. During luxation, minimal muscle tension would be ideal, while after reduction of the joint, normal muscle tension is desired to permit assessment of the mechanics of the hip joint.
The aim of the study is to investigate whether deep neuromuscular block, combined with a reversal before mechanics assessment improves surgical conditions, surgical time, and postoperative patient comfort.
Detailed description
2X20 patients are randomised: Rocuronium-group (R-group) and Placebo-group (P-group).
All patients receive standardised multimodal intravenous analgesia. After standardised induction of anasthesia and patient positioning, the patient is administered either placebo or rocuronium 0.9 mg/kg, followed by continuous infusion of either placebo or rocuronium 0.4 mg/kg/h. 1 minute before reduction of the hip joint, the patient is administered either sugammadex (R-group) or placebo (P-group) for full reversal of the neuromuscular block.
During the surgery, time points are recorded for: incision, start luxation of the joint, start reduction of the joint, start skin closure.
The surgeon is blinded for patient allocation. At three moments (after luxation, just before reduction of the joint, and after assessment of joint mechanics), the surgeon is asked to appraise the surgical conditions on an analogue scale.
Postoperative analgesic consumption and pain scores are recorded. VAS scores for knee pain and hip pain are assessed before surgery, at the moment of discharge from the post-anesthesia care unit (=D0), the morning after surgery (=D1), at D2, and at D7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A receives rocuronium, followed by sugammadex. Group B receives placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo alternative for rocuronium and for sugammadex |
| Rocuronium | Active comparator | Drug: Rocuronium, Drug: SugammadexRocuronium as bolus and in syringe pump Sugammadex just before reduction of the joint |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- signed informed consent
- eligible for primary THA
- BMI <35
Key exclusion criteria (2 listed)
- neurological or psychiatric disorders
- intolerance or allergy against investigational drugs or any of the drugs used in the standardized analgetics scheme (acetaminophen, diclofenac, ketamine, clonidine, lidocaine)
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 |
|---|---|---|
| RocuroniumAlso: Esmeronrocuronium is administered in bolus and continuous infusion | Drug | Rocuronium |
| SugammadexAlso: BridionSugammadex is administered just before reduction of the joint | Drug | Rocuronium |
| PlaceboAlso: Saline 0.9%Placebo is administered as alternative to rocuronium in a bolus and in a syringe pump. Placebo is administered as alternative to sugammadex | Drug | Placebo |
Primary outcome
Surgical conditions during luxation on a four-grade numeric scale
Time frame: during surgery, during luxation of the joint
Excellent - good but not optimal - poor but acceptable - unacceptable
4 secondary outcomes
Patient reported pain scores on a VAS score (0-100 ; 0=no pain , 100=worst pain)
Time frame: day 0-1-2-7 (day 0 = day of surgery)
surgery time
Time frame: during surgery
Surgical conditions during reduction of the joint on a four-grade numeric scale
Time frame: during surgery, during reduction of the joint
Surgical conditions for assessment of joint kinetics on a four-grade numeric scale
Time frame: during surgery, after reduction of the joint
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: Undecided. scores of surgical conditions patient-reported pain scores data about surgery time
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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.
Alain F Kalmar, MD, PhD, MSc principal investigator
Maria Middelares Hospital
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 Rocuronium and Sugammadex in people with Surgery and Postoperative Pain, run by Algemeen Ziekenhuis Maria Middelares 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 12 Mar 2019. 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Surgical conditions during luxation on a four-grade numeric scale (time frame: during surgery, during luxation of the joint). 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 12 Mar 2019.