A Phase 3 interventional study of ropivacaine + ketorolac + adrenaline in Postoperative Pain Intensity and Rescue Pain Requirements, sponsored by Örebro University, Sweden. Completed at 3 sites in Sweden. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-09-27.
Sponsored by Örebro University, Sweden · Phase 3, Interventional, and Treatment
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.
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:
5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's enrollment of 55 is below the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Örebro University, Sweden is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Local infiltration analgesia using a combination of ropivacaine 300 mg + ketorolac 30 mg + adrenaline 0.5 mg
Drug: ropivacaine + ketorolac + adrenaline
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
Pain intensity
Pain intensity during movement at 24 h after end of surgery
Time frame: 24 h
Rescue analgesic consumption
Amount of PCA morphine used for pain management
Time frame: 0-24 h
Chronic pain
Pain at 3 and 6 months after surgery using Brief Pain Inventory
Time frame: 3-6 months
Inflammation
Pre- and post-operative cytokine concentration would be measured
Time frame: Preoperative to 3-5 days postoperatively
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Örebro University, Sweden