Effect of NMBA on Surgical Conditions in THR

Surgery Clinical Trial

Official title:

Effect of Neuromuscular Blockade on Surgical Conditions and Patient Reported Comfort Scores in Total Hip Replacement Arthroplasty

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03369782
• Other study ID #: MMS.2017.033
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 15, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: March 2019
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 31, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Surgery

Intervention

Drug:
• Rocuronium
rocuronium is administered in bolus and continuous infusion
• Sugammadex
Sugammadex is administered just before reduction of the joint
• Placebo
Placebo is administered as alternative to rocuronium in a bolus and in a syringe pump. Placebo is administered as alternative to sugammadex

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Gent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	surgery time	time (in minutes) of surgery between incision and reduction, and between reduction and skin closure	during surgery
Secondary	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
Secondary	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