The Effect of S-ketamine Combined With Sufentanil for Postoperative Analgesia in Patients Following Cesarean Section

The Effect of Low-dose of S-ketamine Combined With Sufentanil for Postoperative Patient-controlled Intravenous Analgesia in Patients Following Cesarean Section

This randomized controlled trial is designed to investigate the effect of low-dose of S-ketamine combined with sufentanil for postoperative patient-controlled intravenous analgesia in patients following cesarean section.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section; S-ketamine; Analgesia, Patient-Controlled
• Intervention / Treatment: Drug: S-ketamine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ling Dong, Ph.D; Phone Number: 18866862815; Email: dongling1668@163.com
• Study Contact Backup: Name: Ling Dong, MD; Phone Number: 18866862815; Email: dongling1668@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
      • Contact: Ling Dong, Ph.D; Phone Number: 18866862815; Email: dongling1668@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status II
• Patients aged between 20 and 40 years
• 18 kg/m² ≤BMI≤30 kg/m²
• singleton term pregnancy
• scheduled for elective cesarean section

Exclusion Criteria:

• Refused to participant in this trial
• Severe heart dysfunction or pulmonary insufficiency
• Poor blood pressure control in those with hypertension (BP >160/100 mmHg in the ward)
• Previous history of Intracranial hypertension or hyperthyroidism
• Previous history of schizophrenia, epilepsy, myasthenia gravis or delirium
• Allergy to drugs used in the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S-ketamine group; The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.	Drug: S-ketamine; After surgery, patient-controlled analgesia is provided. The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. The pump is programmed to deliver 2 ml boluses with a background infusion rate at 2 ml /h and a 30 min lockout interval.
Placebo Comparator: Control group; The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.	Drug: Placebo; After surgery, patient-controlled analgesia is provided. The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. The pump is programmed to deliver 2 ml boluses with a background infusion rate at 2 ml /h and a 30 min lockout interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of patients with moderate-to-severe pain	Moderate-to-severe pain is defined as a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) pain score ≥4.	Up to 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS pain score at rest and with movement	Pain is assessed with a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain)	Hour 12 & Hour 24 & Hour 48 after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total number of presses of Patient-controlled Analgesia (PCA)	The total number of presses of PCA	Up to 48 hours after surgery
The percentage of using rescue analgesics	The percentage of using rescue analgesics	Up to 48 hours after surgery
The Richmond Agitation-Sedation Scale(RASS)	Sedation is assessed with a numeric rating scale(RASS;an 10-point scale with -5 to +4)	Hour 12 & Hour 24 & Hour 48 after surgery
The incidence of postoperative adverse event	postoperative adverse event with nausea,vomiting,dizziness,nightmares, hallucination and etc	Up to 48 hours after surgery

Collaborators and Investigators

• Sponsor: Ling Dong

Publications and helpful links

General Publications

• Brinck EC, Tiippana E, Heesen M, Bell RF, Straube S, Moore RA, Kontinen V. Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database Syst Rev. 2018 Dec 20;12(12):CD012033. doi: 10.1002/14651858.CD012033.pub4.
• Schwenk ES, Viscusi ER, Buvanendran A, Hurley RW, Wasan AD, Narouze S, Bhatia A, Davis FN, Hooten WM, Cohen SP. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):456-466. doi: 10.1097/AAP.0000000000000806.
• Isik Y, Dag ZO, Tulmac OB, Pek E. Early postpartum lactation effects of cesarean and vaginal birth. Ginekol Pol. 2016;87(6):426-30. doi: 10.5603/GP.2016.0020.
• Hobbs AJ, Mannion CA, McDonald SW, Brockway M, Tough SC. The impact of caesarean section on breastfeeding initiation, duration and difficulties in the first four months postpartum. BMC Pregnancy Childbirth. 2016 Apr 26;16:90. doi: 10.1186/s12884-016-0876-1.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: February 26, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 25, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Psychotropic Drugs; Antidepressive Agents; Ketamine; Esketamine
• Other Study ID Numbers: YXLL-KY-2021(071)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No