Effect of NMBA on Surgical Conditions in THR

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Neuromuscular Blockade on Surgical Conditions and Patient Reported Comfort Scores in Total Hip Replacement Arthroplasty

Conditions
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Surgery, Postoperative Pain

Intervention / Treatment
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* Drug: Rocuronium
* Drug: Sugammadex
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A receives rocuronium, followed by sugammadex. Group B receives placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo alternative for rocuronium and for sugammadex | Drug: Placebo<br>* Placebo is administered as alternative to rocuronium in a bolus and in a syringe pump. Placebo is administered as alternative to sugammadex<br>* Other names: Saline 0.9%;|
| Active Comparator: Rocuronium<br>Rocuronium as bolus and in syringe pump Sugammadex just before reduction of the joint | Drug: Rocuronium<br>* rocuronium is administered in bolus and continuous infusion<br>* Other names: Esmeron;Drug: Sugammadex<br>* Sugammadex is administered just before reduction of the joint<br>* Other names: Bridion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical conditions during luxation on a four-grade numeric scale | 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) | 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 (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 | 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 | Excellent - good but not optimal - poor but acceptable - unacceptable | during surgery, after reduction of the joint | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle Tension, Skeletal Muscle Relaxants, Arthroplasties, Hip Replacement, Rocuronium, sugammadex