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OpenTrials
Completed

NCT Number: NCT05160493

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Normal saline and placebo capsule

Drug

Normal saline and placebo capsule

Primary outcomes

  1. Proportion of craniotomy patients with NRS score greater than one 3 months after surgery

    Time frame: 3 months after surgery

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Dec 16, 2021
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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