The Effect of Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients After Craniotomy.

July 30, 2024 updated by: Ruquan Han, Beijing Tiantan Hospital
Chronic postsurgical pain (CPSP), which is one of the most common and serious long term complication of surgery，occurs in approximately 10% of patients after a surgical procedure. Craniotomy was previously considered to have less chronic pain than other surgical procedures. Contrarily, studies have reported incidences of chronic headache varies for type of craniotomy, ranging from 23% to 34% at three months and 12% to 16% at one year after surgery. In addition，CPSP is associated with adverse events, including postoperative morbidity, increased health-care costs, significant impaired on quality of life, prolonged opioid use. Optimising perioperative pain management should reduce the incidence of CPSP; The non-opioid analgesics, such as ketamine and pregabalin, have also been used as components of multimodal anesthetic protocols. Postoperative pain scores and opioid use are significantly reduced in thoracotomy surgical patients given ketamine and pregabalin compared to control groups.however, there is currently a lack of evidence regarding which therapeutic options are most effective in reducing the incidence of chronic post-craniotomy headache. The investigators hypothesis is that sketamine combined with pregabalin reduces significantly chronic postoperative pain after craniotomy and improves patient outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults, age ≥18 years, male or female
  • American Society of Anaesthesiology (ASA) status I-III
  • Patients undergoing elective craniotomy

Exclusion Criteria:

  • Patients unable to complete scale assessment
  • Pregnant or lactating women
  • Patients with preoperative chronic pain syndrome
  • Patients with previous craniotomy history
  • Patients with a history of mental illness who are receiving medication
  • Patients with liver and kidney dysfunction
  • Patients have taken pain medication within two weeks
  • Patients with history of adverse reactions to pregabalin, ketamine and esticketamine
  • Patients with history of drug abuse;
  • BMI>35.0 kg · m - 2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-ketamine and pregabalin

Drug: S-ketamine and pregabalin

  • 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 7days(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
Drug: S-ketamine and pregabalin

S-ketamine and pregabalin

  • 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 7days(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
Placebo Comparator: Normal saline and placebo capsule

Drug: Normal saline and placebo capsule

  • 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
Drug: Normal saline and placebo capsule
Normal saline and placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of craniotomy patients with NRS score greater than one 3 months after surgery
Time Frame: 3 months after surgery
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

  • Study Chair: Ruquan Han, M.D., Ph D., Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2021

Primary Completion (Actual)

December 11, 2023

Study Completion (Actual)

June 20, 2024

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20211206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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