Clinical Trials for Hip Arthroplasty
This article provides information about ongoing clinical trials exploring pain management and blood loss reduction strategies for patients undergoing hip arthroplasty (hip replacement surgery). These studies are investigating various medications and anesthesia techniques, including regional nerve blocks, pain relief medications, and blood-conserving agents. Currently, 5 clinical trials are recruiting participants across several European countries.
Clinical trial locations
- Belgium
- France
- Netherlands
- Spain
Study Comparing PENG Block and Lumbar Plexus Block for Pain Relief and Mobility After Hip Replacement Using Levobupivacaine and Sodium Chloride in Hip Surgery Patients
This trial is comparing two different regional anesthesia techniques to manage pain after hip replacement surgery. The study is taking place in Spain and aims to determine which method provides better pain relief while maintaining muscle strength in the thigh.
Main inclusion criteria: Patients scheduled for primary hip replacement surgery who are willing to participate and sign informed consent. Both men and women of appropriate age can join the study.
Main exclusion criteria: Patients with previous hip replacement surgery, severe allergies to study medications, bleeding disorders, those taking blood-thinning medications, severe heart or lung conditions, local infections, pregnant or breastfeeding women, inability to provide informed consent, history of substance abuse, or participation in another trial.
Focus: The study compares the PENG block and lumbar plexus block techniques, both involving the injection of anesthetic near nerves to block pain signals. Researchers will monitor pain levels, muscle strength, side effects like nausea or sedation, the need for additional pain relief, opioid consumption, and length of hospital stay. The goal is to identify which technique better supports recovery and mobility after surgery.
Investigational treatments: The study uses levobupivacaine as a local anesthetic delivered through either a PENG block (injected near the hip joint) or a lumbar plexus block (injected near nerves in the lower back). Both techniques aim to provide effective pain relief while preserving patient mobility.
Study on Pain Relief After Hip Replacement Surgery Using Morphine, Ropivacaine, and Bupivacaine for Patients Undergoing Spinal Anesthesia
This Belgian trial is examining whether combining intrathecal morphine (pain medication injected into the spinal area) with a nerve block using ropivacaine can improve pain control after hip replacement surgery performed under spinal anesthesia.
Main inclusion criteria: Adults between 18 and 85 years old who can speak, read, and understand French. Participants must be admitted for planned hip replacement surgery using spinal anesthesia and have an American Society of Anesthesiologists Physical Status of 1, 2, or 3.
Main exclusion criteria: Patients not undergoing the specified surgery under spinal anesthesia, those outside the age range, those not meeting the clinical trial group criteria, and members of vulnerable populations.
Focus: The study monitors pain levels using a 0-10 scale at multiple time points after surgery, including 8 hours post-surgery and at regular intervals over the first two days. Researchers track the total amount of morphine needed during the first 48 hours, assess side effects such as nausea and dizziness, and evaluate functional recovery using standardized questionnaires.
Investigational treatments: Intrathecal morphine is injected into the spinal canal to provide pain relief. Some participants also receive a nerve block using ropivacaine, which numbs the hip area by blocking nearby nerves. The combination aims to enhance pain control and reduce the need for additional pain medication.
Study on the Effects of Nefopam and Sodium Chloride for Pain Relief After Total Hip Replacement Surgery
This French trial is evaluating whether nefopam, a non-opioid pain medication, can reduce the need for morphine after hip replacement surgery. The study compares two methods of giving nefopam: as small separate doses or as a continuous infusion.
Main inclusion criteria: French-speaking patients aged 18 or older scheduled for hip replacement surgery (whether first-time or revision) who will receive paracetamol and ketoprofen after surgery. Participants must be undergoing general or spinal anesthesia without morphine in the spinal fluid, be affiliated with a social security system, and provide written informed consent.
Main exclusion criteria: Patients outside the specified age range, vulnerable populations, those unable to give consent, those with medical conditions interfering with study participation, participation in another trial, allergies to study medications, pregnant or breastfeeding women, history of substance abuse, and serious mental health conditions affecting participation.
Focus: The study measures pain levels at rest and during movement, tracks morphine use, evaluates recovery of physical function including walking and stair-climbing ability, and monitors side effects. Follow-up assessments at six months examine chronic pain and nerve pain. The trial also assesses the economic impact of using nefopam as part of pain management over five years.
Investigational treatments: Nefopam is given intravenously either as a continuous infusion or in separate doses, combined with paracetamol and NSAIDs. Nefopam works by affecting neurotransmitters in the brain that control pain perception, offering a non-opioid option for pain management.
Study on Tranexamic Acid to Reduce Blood Loss in Hip Replacement Surgery for Patients with Hip Arthropathy
This French randomized, double-blind trial is studying how different doses of tranexamic acid can help reduce blood loss during and after hip replacement surgery. The study aims to minimize the drop in hemoglobin levels, which indicates blood loss.
Main inclusion criteria: Adults aged 18 and older who need primary hip replacement surgery scheduled within the next three months. Consent can be provided by the patient, family member, or support person. Both men and women can participate.
Main exclusion criteria: Patients with conditions other than hip arthropathy, those outside the specified age range, and members of vulnerable populations.
Focus: The study measures hemoglobin levels before surgery and on the eighth day after to assess blood loss. It monitors the concentration of tranexamic acid in the blood, tracks the need for blood transfusions, and watches for complications such as blood clots. The trial also evaluates markers of anemia and other serious events.
Investigational treatments: Tranexamic acid is given through intravenous infusion along with sodium chloride solution. The medication works by preventing blood clots from breaking down, which helps reduce bleeding during surgery. Some participants may also receive apixaban, a blood clot prevention medication, taken orally after surgery.
Study on Pain Relief in Hip Replacement Surgery Using Ropivacaine and Adrenaline for Patients Undergoing Total Hip Arthroplasty
This Dutch trial is investigating whether injecting ropivacaine combined with adrenaline directly into the hip joint before surgery can reduce the need for additional pain medication after hip replacement.
Main inclusion criteria: Patients over 18 years old on the waiting list for primary hip replacement performed by participating orthopedic surgeons. Participants must be classified as ASA 1, 2, or 3 (indicating overall health status), be eligible for the enhanced recovery pain and anesthetic protocol, and be willing to provide written informed consent.
Main exclusion criteria: Previous hip replacement surgery, age outside the specified range, vulnerable population status, medical conditions making participation unsafe, and inability to follow study procedures.
Focus: The study tracks the need for additional pain medication during the first six hours after injection and monitors pain levels using a numerical rating scale throughout the hospital stay. Researchers assess the amount of pain medication used, any side effects, and overall patient satisfaction measured by the Net Promoter Score.
Investigational treatments: Ropivacaine, a local anesthetic, is injected directly into the hip joint before surgery to numb the area. Adrenaline is added to help prolong the numbing effect and reduce bleeding. This intra-articular approach aims to provide targeted pain relief and potentially reduce the need for systemic pain medications after surgery.
Summary
These five clinical trials represent diverse approaches to improving outcomes for patients undergoing hip replacement surgery. The studies are distributed across four European countries: Belgium, France (hosting two trials), Netherlands, and Spain. A common theme across all trials is the focus on optimizing pain management strategies, with four of the five studies specifically investigating different pain relief techniques.
The trials examine various medication classes and delivery methods, including regional nerve blocks (PENG and lumbar plexus blocks), local anesthetics (ropivacaine, levobupivacaine), non-opioid analgesics (nefopam), and opioids (morphine). One trial stands apart by focusing on tranexamic acid for reducing blood loss rather than pain management. The studies employ different administration routes, including intrathecal injection, intravenous infusion, intra-articular injection, and perineural injection.
Most trials focus on the immediate postoperative period, monitoring outcomes within the first 24 to 48 hours after surgery. However, some studies include longer-term follow-up, with one French trial tracking participants for up to six months to assess chronic pain development. The trials generally target adult patients aged 18 and older, with one Belgian study setting an upper age limit of 85 years.
These studies reflect ongoing efforts to refine surgical care for hip replacement patients by finding the most effective pain management approaches while minimizing side effects and supporting faster recovery. Patients interested in participating should discuss these options with their healthcare providers to determine eligibility and suitability.
