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Effect of NMBA on Surgical Conditions in THR

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ClinicalTrials.gov Identifier: NCT03369782
Recruitment Status : Not yet recruiting
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Alain Kalmar, MD, PhD, 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.


Condition or disease Intervention/treatment Phase
Surgery Postoperative Pain Drug: Rocuronium Drug: Sugammadex Drug: Placebo Phase 4

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group A receives rocuronium, followed by sugammadex. Group B receives placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The syringes are prepared by the research assistant who was not involved in patient management. The anesthetist and surgeon are blinded for patient allocation.
Primary Purpose: Treatment
Official Title: Effect of Neuromuscular Blockade on Surgical Conditions and Patient Reported Comfort Scores in Total Hip Replacement Arthroplasty
Estimated Study Start Date : December 15, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Esmeron

Drug: Sugammadex
Sugammadex is administered just before reduction of the joint
Other Name: Bridion




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. surgery time [ Time Frame: during surgery ]
    time (in minutes) of surgery between incision and reduction, and between reduction and skin closure

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369782


Contacts
Contact: Alain F Kalmar, MD, PhD, MSc +32 246 17 00 alainkalmar@gmail.com
Contact: Silvie Allaert, M.D. +32 246 17 00 silvie.allaert@azmmsj.be

Locations
Belgium
AZ Maria Middelares
Gent, Oost-Vlaanderen, Belgium, 9000
Sponsors and Collaborators
Algemeen Ziekenhuis Maria Middelares
Investigators
Principal Investigator: Alain F Kalmar, MD, PhD, MSc Maria Middelares Hospital

Responsible Party: Dr. Alain Kalmar, MD, PhD, Staff Anesthetist, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier: NCT03369782     History of Changes
Other Study ID Numbers: MMS.2017.033
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: scores of surgical conditions patient-reported pain scores data about surgery time

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

Keywords provided by Dr. Alain Kalmar, MD, PhD, Algemeen Ziekenhuis Maria Middelares:
Muscle Tension
Skeletal Muscle Relaxants
Arthroplasties, Hip Replacement
Rocuronium
sugammadex

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs