Effect of NMBA on Surgical Conditions in THR

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2018-05-31

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.

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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.

Conditions

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Surgery Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group A receives rocuronium, followed by sugammadex. Group B receives placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The syringes are prepared by the research assistant who was not involved in patient management. The anesthetist and surgeon are blinded for patient allocation.

Study Groups

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Placebo

Placebo alternative for rocuronium and for sugammadex

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is administered as alternative to rocuronium in a bolus and in a syringe pump.

Placebo is administered as alternative to sugammadex

Rocuronium

Rocuronium as bolus and in syringe pump Sugammadex just before reduction of the joint

Group Type ACTIVE_COMPARATOR

Rocuronium

Intervention Type DRUG

rocuronium is administered in bolus and continuous infusion

Sugammadex

Intervention Type DRUG

Sugammadex is administered just before reduction of the joint

Interventions

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Rocuronium

rocuronium is administered in bolus and continuous infusion

Intervention Type DRUG

Sugammadex

Sugammadex is administered just before reduction of the joint

Intervention Type DRUG

Placebo

Placebo is administered as alternative to rocuronium in a bolus and in a syringe pump.

Placebo is administered as alternative to sugammadex

Intervention Type DRUG

Other Intervention Names

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Esmeron Bridion Saline 0.9%

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No