- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03369782
Effect of NMBA on Surgical Conditions in THR
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Oost-Vlaanderen
-
Gent, Oost-Vlaanderen, Belgium, 9000
- AZ Maria Middelares
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- signed informed consent
- eligible for primary THA
- BMI <35
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo alternative for rocuronium and for sugammadex
|
Placebo is administered as alternative to rocuronium in a bolus and in a syringe pump. Placebo is administered as alternative to sugammadex
Other Names:
|
Active Comparator: Rocuronium
Rocuronium as bolus and in syringe pump Sugammadex just before reduction of the joint
|
rocuronium is administered in bolus and continuous infusion
Other Names:
Sugammadex is administered just before reduction of the joint
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
during surgery, during luxation of the joint
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Patient reported pain scores in knee and hip after surgery at day 0-1-2-7
|
day 0-1-2-7 (day 0 = day of surgery)
|
surgery time
Time Frame: during surgery
|
time (in minutes) of surgery between incision and reduction, and between reduction and skin closure
|
during surgery
|
Surgical conditions during reduction of the joint on a four-grade numeric scale
Time Frame: during surgery, during reduction of the joint
|
Excellent - good but not optimal - poor but acceptable - unacceptable
|
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
|
Excellent - good but not optimal - poor but acceptable - unacceptable
|
during surgery, after reduction of the joint
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alain F Kalmar, MD, PhD, MSc, Maria Middelares Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMS.2017.033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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