quality of recovery (QoR15) measured by 15 questions evaluating condition of recovery) scale 0 to 15 with 0 being very bad while 15 being maximum recovery possible or equal to pre operative state.
Impact of Opioid Free Anesthesia on Outcome After Hip Arthroplasty by Direct Anterior Approach.
Brief Summary
all patients with a first anterior arthroplasty, give their informed consent to be randomized to control or study protocol.
control means no high steroid dose, opioids for anesthesia; paracetamol, NSAIDs and opioids as analgesia.
study protocol means methylprednisolone 125 mg and opioid free anesthesia followed by paracetamol, NSAIDs and if needed opioids as escape.
Intervention / Treatment
-
study group (PROCEDURE)1. High dose corticoids pre-operative and 24h postoperative 2. Opioid free general anesthesia 3. Avoid opioids post-operative by continue clonidine, ketamine and lidocaine, only exceptional opioids after NSAID and paracetamol.
-
Control (PROCEDURE)1. No corticoids pre-operative. 2. Opioid anesthesia 3. Opioids post-operative after NSAID and paracetamol.
Condition or Disease
- Hip Arthropathy
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 42 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
Masking |
|
Clinical Trial Dates
| Start date: | Mar 01, 2019 | ACTUAL |
|---|---|---|
| Primary Completion: | Oct 01, 2019 | ACTUAL |
| Completion Date: | Nov 01, 2019 | ACTUAL |
| Study First Posted: | Sep 10, 2018 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Nov 17, 2019 |
Sponsors / Collaborators
Lead Sponsor:
AZ Sint-Jan AV
Responsible Party:
N/A
Location
study group means for Anesthesia:
1. High dose corticoids pre-operative: 125 mg Methylprednisolone. (Medrol) pre incision and 24h postoperative
2. OFA using a multimodal approach including alpha2agonists, lidocaine and low dose ketamine (max 1mg/kg).
3. Avoid opioids post-operative by using multimodal non-opioid analgesics after OFA. Avoid epidural to allow rapid mobilization.
all patients get Tranexamic acid 1 g (2 amp Exacyl 500mg) before and 1 g after surgery. It act as antifibrinolytic to reduce postoperative bleeding. (reversibly binding to lysine receptor sites on plasminogen) Try to give Continuous deep neuromuscular block (NMB) with a post titanic count (PTC) \< 3 by continuous infusion and monitoring of NMB.
Intravenous Fluid restrictions to 1 ml/kg/h as long as pulse pressure (or plethysmograph) variation \< 20% to reduce wound edema.
The pericapsular injections of local anesthetic, provided the patient had no contraindications such as poor renal function or allergies. 100 ml Ropivacaine 0,2% (max dose 3 mg/kg) + additives (Adrenaline 2,5 cc) (Ropivacaine: max 3 mg/kg)
1. High dose corticoids pre-operative: 125 mg Methylprednisolone. (Medrol) pre incision and 24h postoperative
2. OFA using a multimodal approach including alpha2agonists, lidocaine and low dose ketamine (max 1mg/kg).
3. Avoid opioids post-operative by using multimodal non-opioid analgesics after OFA. Avoid epidural to allow rapid mobilization.
all patients get Tranexamic acid 1 g (2 amp Exacyl 500mg) before and 1 g after surgery. It act as antifibrinolytic to reduce postoperative bleeding. (reversibly binding to lysine receptor sites on plasminogen) Try to give Continuous deep neuromuscular block (NMB) with a post titanic count (PTC) \< 3 by continuous infusion and monitoring of NMB.
Intravenous Fluid restrictions to 1 ml/kg/h as long as pulse pressure (or plethysmograph) variation \< 20% to reduce wound edema.
The pericapsular injections of local anesthetic, provided the patient had no contraindications such as poor renal function or allergies. 100 ml Ropivacaine 0,2% (max dose 3 mg/kg) + additives (Adrenaline 2,5 cc) (Ropivacaine: max 3 mg/kg)
Participant Groups
-
standard anesthesia using opioids
-
opioid free anesthesia and high dose glucocorticoids
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* arthroplasty by anterior approach
Exclusion Criteria:
* allergy or impossible to use any of the drugs included
* revision procedure
* major cardiovascular, pulmonary or renal insufficiency requiring planned post operative intensive care admission
* arthroplasty by anterior approach
Exclusion Criteria:
* allergy or impossible to use any of the drugs included
* revision procedure
* major cardiovascular, pulmonary or renal insufficiency requiring planned post operative intensive care admission
Primary Outcomes
-
-
opioid use postoperative at 24 hours
-
Chronic reactive protein (CRP) change 24 h post-operative
Secondary Outcomes
-
surgeon scores the surgical conditions on an adapted five-point Leyden scale
-
surgeon scores the muscle damage on an adapted five-point Leyden scale
-
number days patient stay in the hospital before discharge
-
complications up to two weeks postoperative
More Details
| NCT Number: | NCT03663426 |
|---|---|
| Other IDs: | RCT impact OFA on THP |
| Study URL: | https://clinicaltrials.gov/study/NCT03663426 |
Last updated: Sep 29, 2023