Postoperative Analgesic Effect of Esketamine

Analgesia Clinical Trial

Official title:

Epidural Esketamine and Morphine for Postoperative Analgesia After Caesarean Delivery: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05582135
• Other study ID #: XuanhanCo
• Status: Completed
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: August 16, 2021

Study information

• Verified date: October 2022
• Source: Xuanhan County People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to determine whether the addition of esketamine to morphine would improve postoperative analgesia after caesarean section. Parturients who planned for a caesarean delivery using combined spinal-epidural anaesthesia with a request for postoperative anaesthesia were randomly divided into four groups (A, B, C and D). When the surgery was completed, the parturients in groups A, B, C and D were administered 2 mg morphine, 0.25mg/kg of esketamine, 0.25mg/kg of esketamine plus 2 mg morphine sulfate and 0.25mg/kg of esketamine plus 1 mg morphine through the epidural catheters, respectively. The postoperative pain at rest, pain with movement, the number of rescue analgesics and adverse effects were evaluated for 48 h after caesarean delivery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: August 16, 2021
• Est. primary completion date: August 16, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 32 Years

Eligibility

Inclusion Criteria:

• nulliparous parturients who scheduled for elective caesarean delivery under spinal-epidural anaesthesia;
• parturients who had requested postoperative analgesia;
• parturients aged between 20-35 years old;
• parturients who had a full-term pregnancy;
• parturients who were identified as having a singleton pregnancy; and
• parturients who were categorised as having an American Society of Anaesthesiologists (ASA) physical status

Exclusion Criteria:

• parturients with severe internal, surgical or obstetric comorbidities (including spinal deformities, hypertension, placental abruption, cholestasis in pregnancy, asthma, heart disease and abnormal coagulation parameters)
• parturients with a known allergy to the drugs used in this study
• parturients with severe mental illness who could not comply with doctors' instructions
• parturients with chronic pain syndrome, which is defined as pain that persists for a period longer than 3 months

Related Conditions & MeSH terms

• Analgesia
• Dystocia

Intervention

Drug:
• 2 mg morphine sulfate
The parturients were administered 2 mg morphine sulfate through the epidural catheter. Sterile saline was added to make a total volume of 8 mL.
• 0.25mg/kg esketamine
The parturients were administered 0.25mg/kg of esketamine through the epidural catheter. Sterile saline was added to make a total volume of 8 mL.
• 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate
The parturients were administered 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate through the epidural catheter. Sterile saline was added to all combinations of the analgesic drugs to make a total volume of 8 mL.
• 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate
The parturients were administered 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate through the epidural catheter. Sterile saline was added to all combinations of the analgesic drugs to make a total volume of 8 mL.

Locations

Country	Name	City	State
China	Qijun Ran	Dazhou	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Xuanhan County People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain score at rest	The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.	Two hours after caesarean delivery
Primary	Postoperative pain score at rest	The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.	Four hours after caesarean delivery
Primary	Postoperative pain score at rest	The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.	Eight hours after caesarean delivery
Primary	Postoperative pain score at rest	The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.	Twelve hours after caesarean delivery
Primary	Postoperative pain score at rest	The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.	Twenty-four hours after caesarean delivery
Primary	Postoperative pain score at rest	The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.	Forty-eight hours after caesarean delivery
Primary	Postoperative pain score with movement	The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.	Two hours after caesarean delivery
Primary	Postoperative pain score with movement	The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.	Four hours after caesarean delivery
Primary	Postoperative pain score with movement	The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.	Eight hours after caesarean delivery
Primary	Postoperative pain score with movement	The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.	Twelve hours after caesarean delivery
Primary	Postoperative pain score with movement	The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.	Twenty-four hours after caesarean delivery
Primary	Postoperative pain score with movement	The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.	Forty-eight hours after caesarean delivery
Primary	number of rescue analgesics required	The number of rescue analgesics required within 48 h of surgery was recorded	within Forty-eight hours of surgery
Secondary	systolic blood pressure (SBP)	Patient's systolic blood pressure (SBP)	Two hours after caesarean delivery
Secondary	systolic blood pressure (SBP)	Patient's systolic blood pressure (SBP)	Four hours after caesarean delivery
Secondary	systolic blood pressure (SBP)	Patient's systolic blood pressure (SBP)	Eight hours after caesarean delivery
Secondary	systolic blood pressure (SBP)	Patient's systolic blood pressure (SBP)	Twelve hours after caesarean delivery
Secondary	systolic blood pressure (SBP)	Patient's systolic blood pressure (SBP)	Twenty-four hours after caesarean delivery
Secondary	systolic blood pressure (SBP)	Patient's systolic blood pressure (SBP)	Forty-eight hours after caesarean delivery
Secondary	diastolic blood pressure (DBP)	Patient's diastolic blood pressure (DBP)	Two hours after caesarean delivery
Secondary	diastolic blood pressure (DBP)	Patient's diastolic blood pressure (DBP)	Four hours after caesarean delivery
Secondary	diastolic blood pressure (DBP)	Patient's diastolic blood pressure (DBP)	Eight hours after caesarean delivery
Secondary	diastolic blood pressure (DBP)	Patient's diastolic blood pressure (DBP)	Twelve hours after caesarean delivery
Secondary	diastolic blood pressure (DBP)	Patient's diastolic blood pressure (DBP)	Twenty-four hours after caesarean delivery
Secondary	diastolic blood pressure (DBP)	Patient's diastolic blood pressure (DBP)	Forty-eight hours after caesarean delivery
Secondary	heart rate (HR)	Patient's heart rate (HR)	Two hours after caesarean delivery
Secondary	heart rate (HR)	Patient's heart rate (HR)	Four hours after caesarean delivery
Secondary	heart rate (HR)	Patient's heart rate (HR)	Eight hours after caesarean delivery
Secondary	heart rate (HR)	Patient's heart rate (HR)	Twelve hours after caesarean delivery
Secondary	heart rate (HR)	Patient's heart rate (HR)	Twenty-four hours after caesarean delivery
Secondary	heart rate (HR)	Patient's heart rate (HR)	Forty-eight hours after caesarean delivery
Secondary	Blood oxygen saturation (SpO2)	Measurement of pulse Blood oxygen saturation (SpO2) in parturients	Two hours after caesarean delivery
Secondary	Blood oxygen saturation (SpO2)	Measurement of pulse Blood oxygen saturation (SpO2) in parturients	Four hours after caesarean delivery
Secondary	Blood oxygen saturation (SpO2)	Measurement of pulse Blood oxygen saturation (SpO2) in parturients	Eight hours after caesarean delivery
Secondary	Blood oxygen saturation (SpO2)	Measurement of pulse Blood oxygen saturation (SpO2) in parturients	Twelve hours after caesarean delivery
Secondary	Blood oxygen saturation (SpO2)	Measurement of pulse Blood oxygen saturation (SpO2) in parturients	Twenty-four hours after caesarean delivery
Secondary	Blood oxygen saturation (SpO2)	Measurement of pulse Blood oxygen saturation (SpO2) in parturients	Forty-eight hours after caesarean delivery
Secondary	Adverse events	Adverse events that occurred after the administration of study drugs were also recorded.	within Forty-eight hours of surgery