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NCT Number: NCT02568995

Pain Management Following Total Hip Arthroplasty

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.

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Key information

Conditions

Postoperative Pain Intensity Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rescue Pain Requirements Signs and Symptoms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Karolinskasjukhuset, Solna, Sweden

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About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ropivacaine + ketorolac + adrenaline

Drug

A combination of drugs injected locally for postoperative pain management

Primary outcomes

  1. Pain intensity

    Time frame: 24 h

    Pain intensity during movement at 24 h after end of surgery

Secondary outcomes

  1. Rescue analgesic consumption

    Time frame: 0-24 h

    Amount of PCA morphine used for pain management

  2. Chronic pain

    Time frame: 3-6 months

    Pain at 3 and 6 months after surgery using Brief Pain Inventory

  3. Inflammation

    Time frame: Preoperative to 3-5 days postoperatively

    Pre- and post-operative cytokine concentration would be measured

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Registry information

Official study title

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

Acronym: FEMORALIA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 6, 2015
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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