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• Status: Withdrawn
• Conditions: Postoperative Pain; Surgery
• Intervention / Treatment: Drug: Placebo; Drug: Rocuronium; Drug: Sugammadex

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: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • AZ Maria Middelares

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares
• Investigators: Principal Investigator: Alain F Kalmar, MD, PhD, MSc, Maria Middelares Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2017
• Primary Completion (Anticipated): April 30, 2018
• Study Completion (Anticipated): May 31, 2018

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Rocuronium; sugammadex; Muscle Tension; Skeletal Muscle Relaxants; Arthroplasties, Hip Replacement
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: MMS.2017.033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: scores of surgical conditions patient-reported pain scores data about surgery time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No