Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.
Primary Purpose
Esketamine, Pregabalin, Acute Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S-ketamine and pregabalin
Normal saline and placebo capsule
Sponsored by
About this trial
This is an interventional treatment trial for Esketamine
Eligibility Criteria
Inclusion Criteria:
- Patient undergoing elective spinal cord neoplasms resection;
- 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.
Sites / Locations
- Beijing Tiantan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
S-ketamine and pregabalin
Normal saline and placebo capsule
Arm Description
Outcomes
Primary Outcome Measures
the proportion of patients with acute moderate-to-severe postsurgical pain during 48h after operation
The primary outcome was the proportion of patients with acute moderate-to-severe postsurgical pain during the 48-h postoperative period (defined as a VAS score ≥ 40 mm).
Secondary Outcome Measures
Full Information
NCT ID
NCT05096468
First Posted
October 15, 2021
Last Updated
July 4, 2023
Sponsor
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05096468
Brief Title
Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.
Official Title
Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
October 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Postsurgical pain is now known to be one of the most common and difficult-to-treat complications of surgery. severe postoperative pain can significantly impair patients' quality of life, social functioning and contribute to excessive health care expenditures. It is worth noting that acute postoperative pain may play a vital role in central sensitization and up-regulation of pain receptors, even factors implicated in the development of CPSP. According to previous studies, the incidence of postoperative pain among patients undergoing spinal surgery was nearly 80%. At the same time, perioperative pain management of patients undergoing spinal surgery has not been clearly. For the past few years, pregabalin and esketamine are becoming important roles in perioperative pain management, lots of studies have shown that these two analgesics might relieve postoperative pain. The aim of this study was to evaluate the acute analgesic effects of esketamine and pregabalin in combination after spinal cord neoplasms resection, so as to find a better way to help the patients undergoing spinal surgery keep away from the acute perioperative pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esketamine, Pregabalin, Acute Postoperative Pain, Neurosurgical Procedures, Perioperative Complication, Spinal Cord Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S-ketamine and pregabalin
Arm Type
Experimental
Arm Title
Normal saline and placebo capsule
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
S-ketamine and pregabalin
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Normal saline and placebo capsule
Intervention 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
Primary Outcome Measure Information:
Title
the proportion of patients with acute moderate-to-severe postsurgical pain during 48h after operation
Description
The primary outcome was the proportion of patients with acute moderate-to-severe postsurgical pain during the 48-h postoperative period (defined as a VAS score ≥ 40 mm).
Time Frame
48 hours after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient undergoing elective spinal cord neoplasms resection;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph D.
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
ZIP/Postal Code
100070
Country
China
12. IPD Sharing Statement
Learn more about this trial
Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.
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