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

NCT ID: NCT05096468

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-10-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

S-ketamine and pregabalin

Group Type: EXPERIMENTAL

S-ketamine and pregabalin

Intervention Type: 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

Normal saline and placebo capsule

Group Type: PLACEBO_COMPARATOR

Normal saline and placebo capsule

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruquan Han

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruquan Han, M.D., Ph D.

Role: STUDY_CHAIR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital

Beijing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38501980 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36841794 (View on PubMed)

Other Identifiers

Z19110000661906703

Identifier Type: -

Identifier Source: org_study_id