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

NCT05096468 | Completed Phase 2

• 1 other identifier: Z19110000661906703
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Esketamine; Pregabalin; Acute Postoperative Pain; Neurosurgical Procedures; Perioperative Complication; Spinal Cord Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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).

  48 hours after operation

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 pregabalin DRUG

* 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 capsule DRUG

* 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

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100070, China

Location

Related Publications (2)

• Zhou Y, Sun W, Fu Y, Wang J, Fan J, Liang Y, Jia W, Han R. Effect of esketamine combined with pregabalin on acute postsurgical pain in patients who underwent resection of spinal neoplasms: a randomized controlled trial. Pain. 2024 Sep 1;165(9):e96-e105. doi: 10.1097/j.pain.0000000000003211. Epub 2024 Mar 15.

  PMID: 38501980 DERIVED

• Sun W, Wang J, Wang J, Fan J, Zhou Y, Wang Y, Han R. Esketamine combined with pregabalin on acute postoperative pain in patients undergoing resection of spinal neoplasms: study protocol for a randomized controlled trial. Trials. 2023 Feb 25;24(1):144. doi: 10.1186/s13063-023-07178-3.

  PMID: 36841794 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Spinal Cord Neoplasms

Interventions

Esketamine; Pregabalin; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ruquan Han, M.D., Ph D.

  Beijing Tiantan Hospital

  STUDY CHAIR

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 15, 2021
• First Posted: October 27, 2021
• Study Start: December 1, 2021
• Primary Completion: June 28, 2022
• Study Completion: October 15, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-07

Locations

CN (1)