Chronic Postsurgical Pain Clinical Trial
Official title:
Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine in reducing chronic post-mastectomy pain. Participants randomized to the first arm will receive a 0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during surgery (up to a maximum of 6 hours) and continued for 2 hours postoperatively. Participants in the second arm will receive a single dose of 0.6 mg/kg of ketamine in the post-anesthesia care unit, and the final group will serve as the control group and receive saline (no ketamine).
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to study the effectiveness of ketamine in reducing PMPS. In a 3-arm, parallel-group study, approximately 750 adult women undergoing mastectomy or prophylactic mastectomy for oncologic reasons will be randomized to one of three arms. Participants in the first arm will receive continuous ketamine infusion starting after anesthetic induction (0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during surgery (with a maximum infusion of 6 hours) plus a postoperative saline dose, and continuation of 0.25 mg/kg/hr ketamine infusion for 2 hours postoperatively). Participants in the second arm will receive a dose of saline after induction, followed by a saline infusion during the surgery plus a single dose of 0.6 mg/kg of ketamine in the PACU, and 2 hours of saline infusion after surgery. The final group will serve as the control group and receive an intraoperative dose of saline, followed by saline infusion plus a postoperative saline dose and 2 hours of saline infusion after surgery. Participants will be followed at 1 and 7 days and 1, 3, 6, and 12 months after surgery. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05572307 -
Peripheral Blood Single Cell Sequencing Analysis of POD and CPSP in Elderly Patients After Total Knee Arthroplasty
|
||
| Not yet recruiting |
NCT06062550 -
Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia After Scoliosis Correction Surgery
|
Phase 4 | |
| Completed |
NCT04924010 -
Effect of Perioperative CBT on Chronic Persistent Postsurgical Pain Among Breast Cancer Patients
|
N/A | |
| Completed |
NCT04866147 -
Prediction of Chronic Postsurgical Pain in Adults
|
||
| Completed |
NCT05364216 -
Effect of TPVB on Postoperative Pain and Cognitive Function After VATS in Elderly Patients
|
N/A | |
| Not yet recruiting |
NCT06083480 -
Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
|
Phase 4 | |
| Recruiting |
NCT06374849 -
Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery
|
Phase 4 | |
| Active, not recruiting |
NCT05718544 -
Mini-dose Esketamine-dexmedetomidine Supplemented Analgesia and Long-term Outcomes
|
Phase 4 | |
| Not yet recruiting |
NCT06087510 -
Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes
|
Phase 4 | |
| Recruiting |
NCT05196503 -
Efficacy of an Intraoperative Periradicular Application of Platelet Rich Fibrin (PRF) on the Intensity of Residual Post-surgical Neuropathic Pain After a Surgery for Disc Herniation
|
Phase 3 | |
| Not yet recruiting |
NCT06126289 -
CSF Single-cell Sequencing and Proteomics of Chronic Postsurgical Pain in Patients With Lower Limb Fractures
|
||
| Recruiting |
NCT05160493 -
The Effect of Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients After Craniotomy.
|
Phase 2/Phase 3 | |
| Completed |
NCT01537731 -
Vaginal or Laparoscopic Hysterectomy, Persistent Postsurgical Pain
|
N/A | |
| Completed |
NCT05372406 -
Clinical Prediction Model and External Validation of Chronic Postsurgical Pain in Elders
|
||
| Recruiting |
NCT03847363 -
The Influence of Different Anesthesia on Acute and Chronic Postsurgical Pain After Thoracic Surgery
|