Pain Management Following Total Hip Arthroplasty

NCT02568995 | Completed Phase 3

• 1 other identifier: THA2014
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

Brief Summary

Total hip arthroplasty (THA) is a common and standardized procedure. Postoperative mortality after hip joint replacement is low but some complications remain, including chronic post-surgical pain (1), hip dislocation (2), infection (3), and deep vein thrombosis (4). Strategies that have been identified to reduce morbidity and mortality include: posterior surgical approach, mechanical and pharmacological prophylaxis of deep vein thrombosis, and the use of spinal anesthesia (5). One of the important factors for patient satisfaction with lower limb arthroplasty is good postoperative pain management (6). Poorly managed postoperative pain can lead to chronic post-surgical pain and therefore aggressive postoperative pain management is important (7). Several different methods have been used to treat postoperative pain following THA. Recently, local infiltration analgesia (LIA) using a combination of large volume local anesthetics (LA) and non-steroidal anti-inflammatory agents (NSAID) injected systematically peri-articularly has been used for pain management with variable success (8). We found that better analgesia could be achieved when using LIA compared to intrathecal morphine during the first few days postoperatively (9,10). Ultrasound techniques are commonly used for peripheral nerve blocks and have been shown to reduce pain intensity and may be considered by many to be a standard of care. Specifically, the 3-in-1 block has been commonly used because of its ease of application and good pain management following total hip arthroplasty. The present study aims to compare postoperative pain intensity following local infiltration analgesia with a standardised 3-in-1 block for total hip arthroplasty.

Conditions

Postoperative Pain Intensity; Rescue Pain Requirements

Keywords

postoperative pain; morphine; total hip arthroplasty; femoral nerve block

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain intensity during movement at 24 h after end of surgery

  24 h

Secondary Outcomes (3)

• Rescue analgesic consumption

  0-24 h

• Chronic pain

  3-6 months

• Inflammation

  Preoperative to 3-5 days postoperatively

Study Arms (2)

LIA

EXPERIMENTAL

Local infiltration analgesia using a combination of ropivacaine 300 mg + ketorolac 30 mg + adrenaline 0.5 mg

Drug: ropivacaine + ketorolac + adrenaline

Femoral nerve block

ACTIVE COMPARATOR

Ultrasound guided 3-in-1 block using 30 ml of 0.75% ropivacaine

Drug: ropivacaine + ketorolac + adrenaline

Interventions

ropivacaine + ketorolac + adrenaline DRUG

A combination of drugs injected locally for postoperative pain management

Femoral nerve block; LIA

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• ASA I-II
• THA operation

You may not qualify if:

• Chronic pain requiring opiates
• Language constraints preventing completion of the study
• Contraindications to regional block

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (3)

University Hospital

Örebro, 701 85, Sweden

Location

Örebro University Hospital

Örebro, 70185, Sweden

Location

Karolinskasjukhuset

Solna, Sweden

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Ketorolac; Epinephrine

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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: Associate Professor

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 6, 2015
• Study Start: May 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

SE (3)