Effect of NMBA on Surgical Conditions in THR

Phase 4

Withdrawn

• Conditions: Surgery; Postoperative Pain
• Interventions: Drug: Placebo; Drug: Rocuronium; Drug: Sugammadex

• Registration Number: NCT03369782
• Lead Sponsor: Algemeen Ziekenhuis Maria Middelares

Brief 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. 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 Timeline

• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-11
• Study First Posted: 2017-12-12
• Study Start: 2017-12-15
• Primary Completion: 2018-04-30
• Study Completion: 2018-05-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo alternative for rocuronium and for sugammadex
Rocuronium	Sugammadex	Rocuronium as bolus and in syringe pump Sugammadex just before reduction of the joint
Rocuronium	Rocuronium	Rocuronium as bolus and in syringe pump Sugammadex just before reduction of the joint

Primary Outcome Measures

Name	Time	Method
Surgical conditions during luxation on a four-grade numeric scale	during surgery, during luxation of the joint	Excellent - good but not optimal - poor but acceptable - unacceptable

Secondary Outcome Measures

Name	Time	Method
Patient reported pain scores on a VAS score (0-100 ; 0=no pain , 100=worst pain)	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
Surgical conditions for assessment of joint kinetics on a four-grade numeric scale	during surgery, after reduction of the joint	Excellent - good but not optimal - poor but acceptable - unacceptable
surgery time	during surgery	time (in minutes) of surgery between incision and reduction, and between reduction and skin closure
Surgical conditions during reduction of the joint on a four-grade numeric scale	during surgery, during reduction of the joint	Excellent - good but not optimal - poor but acceptable - unacceptable

Trial Locations

Locations (1)

AZ Maria Middelares; 🇧🇪 Gent, Oost-Vlaanderen, Belgium