Clinical trial NCT03369782: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Surgery
Postoperative Pain
Keywords: Muscle Tension
Skeletal Muscle Relaxants
Arthroplasties, Hip Replacement
Rocuronium
sugammadex
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A receives rocuronium, followed by sugammadex. Group B receives placebo
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Surgical conditions during luxation on a four-grade numeric scale
timeFrame: during surgery, during luxation of the joint
Secondary outcomes:
measure: Patient reported pain scores on a VAS score (0-100 ; 0=no pain , 100=worst pain)
timeFrame: day 0-1-2-7 (day 0 = day of surgery)
measure: surgery time
timeFrame: during surgery
measure: Surgical conditions during reduction of the joint on a four-grade numeric scale
timeFrame: during surgery, during reduction of the joint
measure: Surgical conditions for assessment of joint kinetics on a four-grade numeric scale
timeFrame: during surgery, after reduction of the joint
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Maria Middelares
state: Oost-Vlaanderen
Study officials:
affiliation: Maria Middelares Hospital
name: Alain F Kalmar, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: