Comparison of Two Multimodal Analgesia Regimens in Total Knee Arthroplasty

NCT03990038 | Terminated DMC

• 1 other identifier: MultimodalTKA
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The improvement of postoperative analgesia is an important issue in orthopedic surgery, especially after total knee arthroplasty The use of a peripheral nerve block such as the adductor canal block is favored since it offers a postoperative analgesia superior to opioids, and also preserves the strength of the quadriceps, as opposed to the femoral block. The adductor canal block can be given as a single injection (single shot) or a continuous perineural infusion to extend the block's analgesic duration. It is unclear if the continuous infusion is superior to the single shot. Indeed, a high catheter dislodgement rate is observed for this location and local anesthetics could migrate into the femoral canal, resulting in quadriceps weakness. Alternatively, adequate postoperative analgesia has been shown effective with a single shot adductor canal block combined with extended release opioids. The primary objective in this study is to compare two analgesic protocols on the pain score at walk 24 hours after total knee arthroplasty. Here are the two protocols compared :

1. 1.Adductor canal block followed by continuous perineural perfusion for 48 hours
2. 2.Adductor canal block (single shot) followed by hydromorphone extended release formulation for 48 hours In addition to analgesic adjuvants administered in both groups : acetaminophen, celecoxib, pregabalin, dexamethasone and periarticular infiltration.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Pain score during walking (24 hours)

  Verbal Numeric Scale pain score (0-10, where 0= no pain and 10= worst conceivable pain) during walking

  24 hours postoperatively

Secondary Outcomes (18)

• Pain score during walking (48 hours)

  48 hours postoperatively

• Pain score at rest (24 hours)

  24 hours postoperatively

• Pain score at rest (48 hours)

  48 hours postoperatively

• Pain score at knee flexion (24 hours)

  24 hours postoperatively

• Pain score at knee flexion (48 hours)

  48 hours postoperatively

Study Arms (2)

Group C

ACTIVE COMPARATOR

Adductor canal block performed in the pre-operative period with 20 mL of Ropivacaïne 0.5%, followed with a continuous perineural infusion of Ropivacaïne 0.2%, 5 ml/h for 48 hours via a perineural catheter. They will also receive a placebo of Hydromorph Contin 3 mg, administered twice daily for 48h, starting on the evening after surgery

Drug: Continuous perineural infusion of ropivacaine 0.2% 5 ml/h for 48 h

Group U

ACTIVE COMPARATOR

Adductor canal block performed in the pre-operative period with 30 mL of Ropivacaïne 0.5%. A catheter is inserted in the adductor canal but no perineurial infusion. The catheter is connected to a pump that is shut down. They will also receive Hydromorph Contin 3 mg PO administered twice daily for 48 h, starting on the evening after surgery. 4 doses total

Drug: Extended Release Capsule

Interventions

Continuous perineural infusion of ropivacaine 0.2% 5 ml/h for 48 h DRUG

Group C receive the intervention Group U receives the placebo See arm description

Also known as: Continous naropin infusion

Group C

Extended Release Capsule DRUG

Group C receives a placebo for extended release hydromorphone Group U receives Hydromorph Contin 3 mg PO BID See arm description

Also known as: Hydromorph Contin 3 mg PO BID for 48 h

Group U

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years old
• American Society of Anesthesiology physical status I-III
• Primary total knee arthroplasty surgery under regional anesthesia

You may not qualify if:

• Chronic kidney disease (CKD) with eGFR \< 60mL/min
• Contraindications for the use of spinal anesthesia or adductor canal block : infection, sepsis, evolutive neurological disease, coagulopathy, patient refusal.
• Chronic use of opioids (\>30 mg daily morphine equivalent)
• Documented allergy to Hydromorphone, tramadol, celecoxib, ropivacaine, pregabalin, acetaminophen and/or ketorolac
• Patient weight \< 50 kg or BMI \> 40
• Severe cardiac disease
• Severe pulmonary disease
• Chronic use of monoamine oxydase inhibitors
• Pregnancy
• Inability to give informed consent
• Patient refusal

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Ciusss

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Veronique Brulotte, MD

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants won't know their group because this study will use a double placebo: Group U: placebo for extended release hydromorphone (4 doses) Group C: sham perineurial infusion for 48h in group C (Perineurial catheter is connected to perineurial infusion pump but not infusion) Perineural infusion pumps will be covered with an opaque plastic bag to ensure blinding for patients and care providers Nurses and anesthesiologist and physiotherapist will be blinded to patient group allocation Investigator and outcome assessor will be blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Two multimodal analgesic protocols will be compared. Patients will be randomized to one of two analgesic protocol: C: Single-shot adductor canal block followed by a 48h perineurial continuous infusion of ropivacaine U: Single-shot adductor canal block and post operative extended release hydromorphone for 48h (4 doses)

Study Record Dates

• First Submitted: June 15, 2019
• First Posted: June 18, 2019
• Study Start: August 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 2, 2024

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)