Pain Control Following Total Hip Arthroplasty

NCT05062356 | Completed Phase 1

• 1 other identifier: SMHC - 21- 02
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Total hip arthroplasty (THA) is one of the most common surgical procedures performed in elderly patients, with its main indication being end-stage osteoarthritis of the hip1. It is estimated that over 572,000 patients per year will undergo THA in the USA alone by 20301 and postsurgical pain associated with THA remains a significant issue. Postoperative pain is associated with delayed joint mobilization, ambulation, patient satisfaction and can often delay the patient's discharge home1. Multimodal analgesia for the management of postoperative pain following THA is now standard of care2,3. It involves a combination of local anesthetic infiltration (LAI), peripheral nerve blocks (PNBs), analgesics such as non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen and/or other medications, including gabapentinoids and opioids. Using multiple analgesic modalities allows for an easier and faster recovery for THA patients and ultimately allows for reduction in postoperative narcotic use and it's associated negative side effects. Total hip arthroplasty can be performed under either general anesthesia, epidural anesthesia or most commonly under spinal anesthesia, with or without epidural morphine. The adjunctive use of LAI, pericapsular nerve group (PENG) block or suprainguinal fascia iliaca compartment block (FICB) for postoperative pain management is becoming more widespread, although evidence on their efficacy has been inconsistent4-8. As such, comparative evaluation of these adjuctive analgesic modalities is imperative to optimize postoperative pain management following THA.

Conditions

Chronic Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Visual analog pain scale (VAS)

  The primary outcome was chosen as VAS at 4 hours post-op. The investigators debated between VAS score and narcotic consumption, as both have their limitations. VAS score, which is used as primary outcome in most similar studies1, 4-9 can be affected by narcotic consumption and vice-versa. Narcotic consumption is also variable given the need for patients to ask for the medication (with the subjective nature of pain tolerance) and requirement that nursing be available to administer it while in hospital. Some studies have attempted to circumvent these limitations by utilizing patient controlled analgesia (PCA) pumps. The researchers wanted to avoid this because it does not reflect current clinical practice. Therefore, VAS was chosen at 4 hours, a time frame where the spinal effect is likely diminished, the blocks are most effective, the need for breakthrough narcotics is low, being in line with the current literature

  At 4 hours

Secondary Outcomes (1)

• Patient satisfaction with pain control

  at 4 hours

Study Arms (4)

Suprainguinal fascia iliaca compartment block (FICB)

EXPERIMENTAL

Suprainguinal fascia iliaca compartment block (FICB) is a technique that involves injection of local anesthetics underneath the fascia of the iliacus muscle to block the femoral nerve, the lateral femoral cutaneous nerve and, possibly, the obturator nerve.

Drug: Bupivacaine Hydrochloride 0.25% Injection Solution_#2; Drug: EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge; Drug: Ketorolac

Pericapsular nerve group block (PENG)

ACTIVE COMPARATOR

The pericapsular nerve group block (PENG) is a technique that involves injection of local anesthetic in the musculofascial plane between the psoas muscle and the superior pubic ramus.

Drug: EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge; Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#2; Drug: Ketorolac

Local analgesia infiltration (LAI)

SHAM COMPARATOR

local anesthetic infiltration (LAI) into the anterior pericapsular tissues

Drug: Bupivacaine Hydrochloride 0.25% Injection Solution_#2; Drug: EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge; Drug: Ketorolac

No adjunct: spinal anaesthesia (control)

SHAM COMPARATOR

Standard spinal anesthesia technique

Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#2; Drug: Ketorolac

Interventions

Bupivacaine Hydrochloride 0.25% Injection Solution_#2 DRUG

40cc

Local analgesia infiltration (LAI); Suprainguinal fascia iliaca compartment block (FICB)

EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge DRUG

10cc

Local analgesia infiltration (LAI); Pericapsular nerve group block (PENG); Suprainguinal fascia iliaca compartment block (FICB)

Bupivacaine Hydrochloride 0.5% Injection Solution_#2 DRUG

20cc

No adjunct: spinal anaesthesia (control); Pericapsular nerve group block (PENG)

Ketorolac DRUG

15mg

Local analgesia infiltration (LAI); No adjunct: spinal anaesthesia (control); Pericapsular nerve group block (PENG); Suprainguinal fascia iliaca compartment block (FICB)

Eligibility Criteria

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

You may qualify if:

• Adults (≥18 years old) who require an inpatient primary total hip arthroplasty under spinal anesthesia
• Written consent
• Any gender

You may not qualify if:

• Patients who require revision surgery
• Anesthesia other than spinal (general, epidural, other)
• Body mass index (BMI) \> 45 kg/m2
• Allergies to study medication
• Previous fracture to affected area
• Previous surgery to the affected hip
• Diagnosis other than osteoarthritis (avascular necrosis, significant deformity such as post-Perthes, slipped capital femoral epiphysis, dysplasia classified as Crowe 3 or 4, or other diagnoses causing significant deformity of the femoral head or acetabulum)
• THA for hip fractures
• Patients taking daily opiod analgesics pre-operatively
• Anesthetist on day of surgery who does not perform FICB and PENG and no alternate anesthetist available to perform the block
• Patients who do not understand, read or communicate in either French or English

Sponsors & Collaborators

• St. Mary's Research Center, Canada: lead

Study Sites (1)

St. Mary's Hospital Center

Montreal, Quebec, H3T 1M5, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Epinephrine; Prilocaine; Ketorolac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dr. Anthony Albers, MDCM, FRCSC

  McGill University, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Orthopaedic Surgeon

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 30, 2021
• Study Start: November 4, 2021
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

CA (1)