Clinical trial

Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.

Name

Z19110000661906703

Description

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.

Trial arms

Trial start

2021-12-01

Estimated PCD

2022-06-28

Trial end

2022-10-15

Status

Completed

Phase

Early phase I

Treatment

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 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

Arms:

S-ketamine and pregabalin

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

Arms:

Normal saline and placebo capsule

Size

Primary endpoint

the proportion of patients with acute moderate-to-severe postsurgical pain during 48h after operation

48 hours after operation

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

Updated at

2023-07-06

1 organization

2 products

6 indications

Organization

Beijing Tiantan Hospital

Product

S-ketamine and pregabalin

Indication

Esketamine

Indication