Clinical trial NCT05299866: The Effect of S-ketamine Combined With Sufentanil for Postoperative Analgesia in Patients Following Cesarean Section
Official title: The Effect of Low-dose of S-ketamine Combined With Sufentanil for Postoperative Patient-controlled Intravenous Analgesia in Patients Following Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: S-ketamine
Analgesia, Patient-Controlled
Cesarean Section
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 216
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The percentage of patients with moderate-to-severe pain
timeFrame: Up to 48 hours after surgery
Secondary outcomes:
measure: NRS pain score at rest and with movement
timeFrame: Hour 12 & Hour 24 & Hour 48 after surgery
Other outcomes:
measure: The total number of presses of Patient-controlled Analgesia (PCA)
timeFrame: Up to 48 hours after surgery
measure: The percentage of using rescue analgesics
timeFrame: Up to 48 hours after surgery
measure: The Richmond Agitation-Sedation Scale(RASS)
timeFrame: Hour 12 & Hour 24 & Hour 48 after surgery
measure: The incidence of postoperative adverse event
timeFrame: Up to 48 hours after surgery
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
state: Shandong
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.