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Effect of NMBA on Surgical Conditions in THR

Primary Purpose

Surgery, Postoperative Pain

Status
Withdrawn
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Rocuronium
Sugammadex
Placebo
Sponsored by
Algemeen Ziekenhuis Maria Middelares
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring Muscle Tension, Skeletal Muscle Relaxants, Arthroplasties, Hip Replacement, Rocuronium, sugammadex

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • AZ Maria Middelares

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Rocuronium

Arm Description

Placebo alternative for rocuronium and for sugammadex

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

Outcomes

Primary Outcome Measures

Surgical conditions during luxation on a four-grade numeric scale
Excellent - good but not optimal - poor but acceptable - unacceptable

Secondary Outcome Measures

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
surgery time
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
Excellent - good but not optimal - poor but acceptable - unacceptable
Surgical conditions for assessment of joint kinetics on a four-grade numeric scale
Excellent - good but not optimal - poor but acceptable - unacceptable

Full Information

First Posted
December 4, 2017
Last Updated
March 11, 2019
Sponsor
Algemeen Ziekenhuis Maria Middelares
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1. Study Identification

Unique Protocol Identification Number
NCT03369782
Brief Title
Effect of NMBA on Surgical Conditions in THR
Official Title
Effect of Neuromuscular Blockade on Surgical Conditions and Patient Reported Comfort Scores in Total Hip Replacement Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
refocusing of research priorities
Study Start Date
December 15, 2017 (Anticipated)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
May 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Algemeen Ziekenhuis Maria Middelares

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Postoperative Pain
Keywords
Muscle Tension, Skeletal Muscle Relaxants, Arthroplasties, Hip Replacement, Rocuronium, sugammadex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Group A receives rocuronium, followed by sugammadex. Group B receives placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo alternative for rocuronium and for sugammadex
Arm Title
Rocuronium
Arm Type
Active Comparator
Arm Description
Rocuronium as bolus and in syringe pump Sugammadex just before reduction of the joint
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Other Intervention Name(s)
Esmeron
Intervention Description
rocuronium is administered in bolus and continuous infusion
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
Bridion
Intervention Description
Sugammadex is administered just before reduction of the joint
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline 0.9%
Intervention Description
Placebo is administered as alternative to rocuronium in a bolus and in a syringe pump. Placebo is administered as alternative to sugammadex
Primary Outcome Measure Information:
Title
Surgical conditions during luxation on a four-grade numeric scale
Description
Excellent - good but not optimal - poor but acceptable - unacceptable
Time Frame
during surgery, during luxation of the joint
Secondary Outcome Measure Information:
Title
Patient reported pain scores on a VAS score (0-100 ; 0=no pain , 100=worst pain)
Description
Patient reported pain scores in knee and hip after surgery at day 0-1-2-7
Time Frame
day 0-1-2-7 (day 0 = day of surgery)
Title
surgery time
Description
time (in minutes) of surgery between incision and reduction, and between reduction and skin closure
Time Frame
during surgery
Title
Surgical conditions during reduction of the joint on a four-grade numeric scale
Description
Excellent - good but not optimal - poor but acceptable - unacceptable
Time Frame
during surgery, during reduction of the joint
Title
Surgical conditions for assessment of joint kinetics on a four-grade numeric scale
Description
Excellent - good but not optimal - poor but acceptable - unacceptable
Time Frame
during surgery, after reduction of the joint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain F Kalmar, MD, PhD, MSc
Organizational Affiliation
Maria Middelares Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Maria Middelares
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
scores of surgical conditions patient-reported pain scores data about surgery time

Learn more about this trial

Effect of NMBA on Surgical Conditions in THR

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