Pain Management Following Total Hip Arthroplasty (FEMORALIA)

Postoperative Pain Management Following Total Hip Arthroplasty. A Comparison Between Local Infiltration Analgesia and Ultrasound Guided 3-in-1 Block

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain Intensity; Rescue Pain Requirements
• Intervention / Treatment: Drug: ropivacaine + ketorolac + adrenaline

Detailed Description

Sixty ASA I-II patients undergoing THA would be randomised to one of two groups in a double-blind study:

Group LIA: A total of 151.5 ml of a combination of 0.2% ropivacaine (150 ml), 30 mg ketorolac (1 ml) and 0.5 mg (0.5 ml) adrenaline was administered systematically peri-articularly during THA and 30 ml of normal saline for ultrasound-guided 3-in-1 block Group Femoral block: Received 30 ml of ropivacaine 0,75% for ultrasound-guided 3-in-1 block and a total of 151.5 ml of normal saline peri-articularly.

All patients would receive spinal anaesthesia with 0.5% heavy bupivacaine for surgery

Postoperatively, the following parameters would be measured:

1. Pain intensity at fixed time intervals during 0-7 days and thereafter at weekly intervals for 1 month
2. Rescue morphine consumption during 0-4, 4-24 and 24-48 h
3. Side effects and complications
4. Home readiness and length of hospital stay
5. Chronic pain intensity measured after 3 and 6 months using the Brief Pain Inventory
6. Plasma Cytokine concentration at fixed intervals
7. Motor block using Bromage scale
8. EQ5D and HOOS questionnaires

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Solna, Sweden
    • Karolinskasjukhuset
  • Örebro, Sweden, 701 85
    • University Hospital
  • Örebro, Sweden, 70185
    • Orebro University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 40-80 years
• ASA I-II
• THA operation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LIA; Local infiltration analgesia using a combination of ropivacaine 300 mg + ketorolac 30 mg + adrenaline 0.5 mg	Drug: ropivacaine + ketorolac + adrenaline; A combination of drugs injected locally for postoperative pain management
Active Comparator: Femoral nerve block; Ultrasound guided 3-in-1 block using 30 ml of 0.75% ropivacaine	Drug: ropivacaine + ketorolac + adrenaline; A combination of drugs injected locally for postoperative pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity during movement at 24 h after end of surgery	24 h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue analgesic consumption	Amount of PCA morphine used for pain management	0-24 h
Chronic pain	Pain at 3 and 6 months after surgery using Brief Pain Inventory	3-6 months
Inflammation	Pre- and post-operative cytokine concentration would be measured	Preoperative to 3-5 days postoperatively

Collaborators and Investigators

• Sponsor: Örebro University, Sweden

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 2, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimate): October 6, 2015

Study Record Updates

• Last Update Posted (Estimate): September 27, 2016
• Last Update Submitted That Met QC Criteria: September 25, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: total hip arthroplasty; morphine; postoperative pain; femoral nerve block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Neurologic Manifestations; Pain, Postoperative; Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Ketorolac; Ropivacaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: THA2014