Pain Management Following Total Hip Arthroplasty

Postoperative Pain Intensity Clinical Trial

— FEMORALIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02568995
• Other study ID #: THA2014
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2015
• Last updated: September 25, 2016
• Start date: May 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Regional Ethics Committee, Uppsala, Sweden:
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain Intensity
• Rescue Pain Requirements

Intervention

Drug:
• ropivacaine + ketorolac + adrenaline
A combination of drugs injected locally for postoperative pain management

Locations

Country	Name	City	State
Sweden	Örebro University Hospital	Örebro
Sweden	University Hospital	Örebro
Sweden	Karolinskasjukhuset	Solna

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain intensity during movement at 24 h after end of surgery	24 h	No
Secondary	Rescue analgesic consumption	Amount of PCA morphine used for pain management	0-24 h	No
Secondary	Chronic pain	Pain at 3 and 6 months after surgery using Brief Pain Inventory	3-6 months	No
Secondary	Inflammation	Pre- and post-operative cytokine concentration would be measured	Preoperative to 3-5 days postoperatively	No