RCT Deep vs Moderat NMB on Surgical Conditions During THP

Randomized Controlled Trial Comparing the Impact of Deep Versus Moderate/Superficial NMB on Surgical Conditions and Muscle Trauma During Hip Arthroplasty by Direct Anterior Approach Using Minimally Invasive Surgery.

A clinical deep NMB might relax the anterior muscles of the upper leg better than a moderate/superficial block giving a better exposure for the surgeon with less muscle trauma by traction to expose the hip.

a continuous deep NMB (group A) versus a non deep NMB (group B) having a moderate to superficial block imitating common practice today as control group.

Primary objectives are surgical exposure and Secondary objectives are Muscle damage creatine kinase changes, C-reactive protein (CRP), first time leaving bed postoperative, post operative pain as measured by opioid use postoperative at 24h, with a control of max VAS score during first 24 hour, length of hospital stay (LOS), number of adverse events using the Dindo-Clavien surgical complication score, QoR15 measured at 24h on the ward.

Study Overview

• Status: Unknown
• Conditions: Muscle Injury
• Intervention / Treatment: Procedure: deep NMB; Procedure: moderate NMB

Detailed Description

In this study, CRP levels are choosen as it is measured standard in every total hip arthroplasty (THA) procedure. CK is a good biomarker for muscle trauma and therefore chosen as second marker.

The study is blinded for the treating surgeon, who will be making the assessment for the surgical conditions. The attending anesthesiologist is not blinded as he has to measure NMB in both groups and give a rocuronium infusion to stay deep in the study group. The anesthesiologist and the nurses following the patient on the post anesthetic care unit (PACU) and the ward are different from the attending anesthesiologist and are blinded. They will not be informed by the attending anesthesiologist on randomization allocation.

Randomization:

Group A deep NMB group:

• 0,6 mg/kg LBW Rocuronium is used to facilitate intubation, and followed by an infusion of 1 mg/kg LBW/h , further adapted to keep post tetanic count (PTC) < 3 without informing the surgeon of the depth (surgeon is blinded)

Group B moderate to superficial NMB group:

• 0,6 mg/kg LBW rocuronium is used to facilitate intubation, not followed by an infusion or extra bolus.train of four ( TOF) and PTC are measured at the beginning of surgery without informing the surgeon of the depth. (surgeon is blinded)

  2 weeks before surgery at consultation of orthopedics and anesthesia:

• Inclusion criteria, signing informed consent, CRP blood sample
• 15 Quality of recovery questions (QoR15) filled in to have a pre op status

Day before surgery:

• Verification that study can be performed ( equipment, surgeon, anesthesiologist and investigators available) Morning of surgery
• Control signing of informed consent is done and patient still willing to continue the study
• Attending anesthesiologist ask the randomization allocation at the secretary anesthesia without informing surgeon, colleagues and nurses on PACU and ward.

Anesthesia & surgery performed

• CRF is filled in with time stamps, dosing of drugs and monitoring values
• Surgeon is asked for a surgical exposure grading ( 1-5) after initial incision, at the critical moment of prosthesis insertion and before closure.
• In order to measure the degree of muscle damage, one light photo is taken of the muscles before closing and archived for later anonymous scoring by an independent orthopedic surgeon doing also THA by DAA but not around that day in the OR (3 surgeons do frequently THA by DAA).
• If an opioid is given before PACU admission dose and time are noted in the clinical registration file (CRF) PACU
• VAS score is recorded on admission, every hour and before leaving PACU.
• The total dose of opioids given during the PACU are noted in the CRF Ward
• Max visual analog pain score (VAS) during first 24 hours on the ward is noted in the CRF.
• The QoR15 is repeated at 24 hours post surgery
• A CRP blood sample is taken 24 hours post surgery
• The total dose of opioids given on the ward till discharge is noted in the CRF

Home

• 2 weeks after surgery a phone call is given to request healthy state
• and hear of any adverse event or complication.
• and repeat the QoR15 questionnaire by phone

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Paul Mulier, MD PhD; Phone Number: +3250452490; Email: jan.mulier@azsintjan.be
• Study Contact Backup: Name: Jan VanLommel, MD

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Azsintjan

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• • Hip arthroplasty by anterior approach using Minimally Invasive Surgery

Exclusion Criteria:

• • Revision arthroplasty.

  • Allergy or contra indications to use any of the drugs included in anesthesia.
  • Addiction to or chronic opioid use before surgery.
  • Major cardiovascular, pulmonary, liver or renal insufficiency before surgery requiring possible post-operative intensive care admission.
  • Contra indication for a general anesthesia with intubation and mechanical ventilation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: a continuous deep NMB (group A); after 0,6 mg/kg LBW Rocuronium for intubation Rocuronium is given in a continuous infusion starting at 1 mg/kg/h and adapted to keep PTC below 5 and note.	Procedure: deep NMB; 0,6 mg/kg LBW Rocuronium is used to facilitate intubation, and followed by an infusion of 1 mg/kg LBW/h , further adapted to keep PTC < 3
Placebo Comparator: non deep NMB (group B); after 0,6 mg/kg LBW Rocuronium for intubation no extra NMB is given and depth is measured by TOF/PTC to note depth.	Procedure: moderate NMB; 0,6 mg/kg LBW rocuronium is used to facilitate intubation, not followed by an infusion or extra bolus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical exposure	After the surgical procedure the surgeon will be asked to score the surgical conditions on an adapted five point Leiden scale (validated scale): max = 5 and best; min = 1 and worst grade 5: optimal surgical conditions, perfect access to the hip joint and excellent visibility. grade 4: good conditions: adequate surgical conditions to perform the surgery, but not optimal grade 3: just acceptable conditions, surgical procedure is jeopardized, but adequate surgical result is still obtained, eventually after additional intervention grade 2: poor conditions, exposure and handling hindered resulting in suboptimal surgical outcome requiring adaptation of procedure or interventions to improve condition. grade 1: extremely poor conditions, the surgeon is unable to work because of the inability to get access to the hip joint because of inadequate muscle relaxation and request to improve conditions first before continuing.	from incision till end of surgery stop at day zero

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle injury	This is scored on an adapted five point scale post surgery on a light photo taken at end of surgery before closing, by an orthopedic surgeon not around during surgery. max = 5 and best; min = 1 and worst grade 1: muscle severely damaged with open cuts; grade 2: muscle damaged with free tears; grade 3: muscle superficial damaged and swollen; grade 4: muscle intact, but swollen or perfusion not optimal grade 5: muscle intact without swelling and normal perfused.	on photo after procedure stop at day zero
creatinine kinase (CK)	creatinine kinase (CK) changes as a measure for muscle trauma, at 24 hours postoperative versus baseline	24 hours after surgery stop at day 1
C-reactive protein (CRP)	C-reactive protein (CRP) changes as a measure for inflammation, at 24 hours postoperative versus baseline.	24 hours after surgery stop at day 1
leaving bed	First time leaving bed postoperative	within 24 hours postoperative stop at day 1
Length of stay	Length of hospital stay (LOS)	measured in days up to one week post surgery stop at day 7
postoperative complications	Number of adverse events using the Dindo-Clavien surgical complication score	up to two weeks postoperative stop at day 14
quality of recovery	15 Quality of recovery questions (QoR15) measured at 24h on the ward and at 2 weeks post operative max: 150: best; min: 0: worst each question is answered on a scale from 0 to 10.	2 weeks postoperative stop at day 14

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: jan mulier, AZSint Jan AV

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: November 16, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019RCTdeepNMBTHP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No