Pain, Postoperative Clinical Trial
Official title:
Perioperative Methadone for Ameliorating Postoperative Pain and Reduction in Postoperative Opioid Consumption in Hip Fracture Patients - Dosage Adjusting Pilot-study
Postoperative analgesic treatment needs to be improved. Numerous studies suggest that a single dose of Methadone given during surgery significantly ameliorates postoperative pain and reduces postoperative opioid consumption. Perioperative methadone is already used in isolated cases such as patients with chronic pain or patients with high morphine tolerance. However, it is not routinely used in the elderly and fragile, and there is insufficient reliable evidence on this treatment and population. Further investigation is highly relevant and necessary.
A multimodal approach and the use of peripheral nerve blocks have improved the treatment of postoperative pain. However, supplemental opioids are predominantly necessary and often continued for months or years after surgery. In fact, continued use of opioids after surgery is an increasing challenge. Consequently, patients undergoing surgery are at risk of experiencing side effects and developing physical as well as psychological addiction to opioids. The most common opioid-related side effects include obstipation, nausea, itchy skin, dry mouth, vertigo, and sedation. The means to decrease the need for opioids in the postoperative phase are in high demand, and therefore the investigation of perioperative Methadone is highly relevant. Methadone is a lipophilic opioid agonist with a large distribution volume and a very long elimination half-life of 15 - 60 hours. It is also an N-methyl D-aspartate (NMDA) receptor antagonist, which attenuates opioid-induced tolerance and hyperalgesia. Furthermore, Methadone inhibits the reuptake of Serotonin and Noradrenalin, which could positively affect the experience of pain in the postoperative phase. Methadone is mostly excreted through the bile and can, therefore, even be used in patients with reduced kidney function. Methadone's analgesic effects occur only eight minutes after intravenous administration. In most studies, methadone is given perioperatively in dosages of 0.10-0.30 mg/kg and is commenced at the induction of anaesthesia or the initiation of surgery. Studies investigating the optimal dosage and time for administration found that patients receiving methadone after the procedure needed twice as much opioid pain medication on postoperative day one compared to patients receiving methadone at anaesthetic induction. These studies also indicate that using smaller dosages such as 5-10 mg, the analgesic duration is only 3-4 hours, whereas doses of 20 mg or more have a clinical effect closely related to the elimination half-life of 15-60 hours without any increased risk for respiratory depression. The aim of this study is to determine the optimal dose of methadone for a future randomized controlled trial (RCT). The objective is to investigate whether doses greater than 0.10 mg/kg are tolerated with no increased risk to respiratory depression, side effects, or prolonged stay in the post-anaesthesia care units (PACU). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05480111 -
The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy
|
Phase 4 | |
Completed |
NCT06129305 -
Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
|
||
Completed |
NCT04401826 -
Micro-surgical Treatment of Gummy Smile
|
N/A | |
Recruiting |
NCT04020133 -
the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction.
|
N/A | |
Completed |
NCT03023462 -
Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair
|
N/A | |
Completed |
NCT03546738 -
Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery
|
N/A | |
Completed |
NCT03652103 -
Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy
|
Phase 4 | |
Terminated |
NCT03261193 -
ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain
|
Phase 3 | |
Withdrawn |
NCT03528343 -
Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy
|
Phase 1/Phase 2 | |
Completed |
NCT02525133 -
Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
|
Phase 3 | |
Completed |
NCT03244540 -
Regional Analgesia After Cesarean Section
|
Phase 4 | |
Enrolling by invitation |
NCT05316168 -
Post Operative Pain Management for ACL Reconstruction
|
Phase 3 | |
Recruiting |
NCT04130464 -
Intraperitoneal Infusion of Analgesic for Postoperative Pain Management
|
Phase 4 | |
Enrolling by invitation |
NCT04574791 -
Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
|
N/A | |
Completed |
NCT04073069 -
Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults
|
Phase 4 | |
Completed |
NCT04526236 -
Influence of Aging on Perioperative Methadone Dosing
|
Phase 4 | |
Recruiting |
NCT05351229 -
Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery
|
Phase 4 | |
Enrolling by invitation |
NCT05543109 -
Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block
|
N/A | |
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Completed |
NCT04919317 -
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
|
Phase 2 |