NCT06117917

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 31, 2023

Last Update Submit

October 31, 2023

Conditions

EsketaminePregabalineChronic Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • the proportion of patients with chronic postsurgical pain during 3 months after operation

    The primary outcome was the proportion of patients with CPSP during the 3-month postoperative period (defined as a NRS score ≥ 3).

    3 months postoperatively

Study Arms (2)

S-ketamine and pregabalin

EXPERIMENTAL
Drug: S-ketamine and pregabalin

Normal saline and placebo capsule

PLACEBO COMPARATOR
Drug: Normal saline and placebo capsule

Interventions

S-ketamine and pregabalinDRUG

* 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

S-ketamine and pregabalin
Normal saline and placebo capsuleDRUG

* 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

Normal saline and placebo capsule

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100070, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

EsketaminePregabalinSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ruquan Han, M.D., Ph D

    Beijing Tiantan Hospital

    STUDY CHAIR

Central Study Contacts

Ruquan Han, M.D., Ph D

CONTACT

8610-59976660ruquan.han@ccmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 7, 2023

Study Start

November 10, 2023

Primary Completion

May 31, 2024

Study Completion

June 30, 2024

Last Updated

November 7, 2023

Record last verified: 2023-10

Locations

CN(1)