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Trial Title:
Esketamine Combined With Pregabalin on CPSP in Spinal Patients.
NCT ID:
NCT06117917
Condition:
Esketamine
Pregabaline
Chronic Post Operative Pain
Conditions: Official terms:
Pain, Postoperative
Pregabalin
Ketamine
Esketamine
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
S-ketamine and pregabalin
Description:
- Drug: Pregabalin
- 150mg (2hrs) pre operatively and 75mg twice daily post operatively for 7
days(POD1-7), followed by dose reduction to 75mg once daily for 7 days(POD8-14)
- Drug: S-ketamine infusion
- 0.5 mg/kg bolus after induction of anesthesia +0.12 mg/kg/h continuous intravenous
infusion for 48 h
Arm group label:
S-ketamine and pregabalin
Intervention type:
Drug
Intervention name:
Normal saline and placebo capsule
Description:
- Drug: Placebo capsules
- Two placebo capsules (2hrs) preoperatively and twice daily post operatively for
7days, followed by dose reduction to single capsule once daily for 7days
- Drug: Normal saline
- 0.9% saline bolus after induction of anesthesia + intravenous infusion for 48 hours
Arm group label:
Normal saline and placebo capsule
Summary:
Chronic postsurgical pain has become one of the most common complications of surgery. The
quality of life will be impacted once the postsurgical patients are combined with
persistent pain. What's more, the postsurgical pain may increase other adverse outcomes.
It's important to find a better way to keep the postsurgical patients away from
postoperative pain. Esketamine and pregabalin have become potentially effective drugs on
CPSP.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient undergoing elective primary spinal tumor surgery;
- Ages between 18 and 65 years old;
- American Society of Anaesthesiology (ASA) status I-III;
- Signed informed consent.
Exclusion Criteria:
- Previous adverse reaction to ketamine, s-ketamine or pregabalin;
- Patients with a diagnosed history of severe chronic pain;
- Patients with long-term analgesic treatment(gabapentin/opioids/ketamine);
- Patients with aphasia or inability to cooperate with the pain assessments;
- Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic
failure);
- Patients with a diagnosed history of psychiatric disorder;
- Patients treated with gabapentin/pregabalin in the last three months;
- Drug abuse;
- Body mass index (BMI) > 35 kg/m2 ;
- Pregnancy or lactation.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Beijing Tiantan Hospital
Address:
City:
Beijing
Zip:
100070
Country:
China
Contact:
Last name:
Ruquan Han, M.D., Ph D.
Phone:
8610-59976660
Email:
ruquan.han@ccmu.edu.cn
Start date:
November 10, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Beijing Tiantan Hospital
Agency class:
Other
Source:
Beijing Tiantan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06117917
