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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.
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:
Anesthesia & surgery performed
Home
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a continuous deep NMB (group A) | Experimental | 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. |
|
| non deep NMB (group B) | Placebo Comparator | after 0,6 mg/kg LBW Rocuronium for intubation no extra NMB is given and depth is measured by TOF/PTC to note depth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deep NMB | Procedure | 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 |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
• Revision arthroplasty.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Paul Mulier, MD PhD | Contact | +3250452490 | jan.mulier@azsintjan.be | |
| Jan VanLommel, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| jan mulier | AZSint Jan AV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azsintjan | Bruges | 8000 | Belgium |
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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.
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| moderate NMB | Procedure | 0,6 mg/kg LBW rocuronium is used to facilitate intubation, not followed by an infusion or extra bolus. |
|
| 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 |