Postoperative Analgesic Effect of Esketamine

Xuanhan County People's Hospital119 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

119

Conditions

Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed Labor Analgesia

Interventions

2 mg morphine sulfateDRUG

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 esketamineDRUG

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 sulfateDRUG

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 sulfateDRUG

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 32 Years

Medical Language ↔ Plain English

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

Locations (1)

Qijun Ran

Dazhou, Sichuan, China

Outcomes

Primary Outcomes

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.

Time frame: Two hours after caesarean delivery

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.

Time frame: Four hours after caesarean delivery

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.

Time frame: Eight hours after caesarean delivery

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.

Time frame: Twelve hours after caesarean delivery

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.

Time frame: Twenty-four hours after caesarean delivery

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.

Time frame: Forty-eight hours after caesarean delivery

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.

Time frame: Two hours after caesarean delivery

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.

Time frame: Four hours after caesarean delivery

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.

Time frame: Eight hours after caesarean delivery

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.

Time frame: Twelve hours after caesarean delivery

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.

Time frame: Twenty-four hours after caesarean delivery

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.

Time frame: Forty-eight hours after caesarean delivery

number of rescue analgesics required

The number of rescue analgesics required within 48 h of surgery was recorded

Time frame: within Forty-eight hours of surgery

Secondary Outcomes

systolic blood pressure (SBP)

Patient's systolic blood pressure (SBP)

Time frame: Two hours after caesarean delivery

systolic blood pressure (SBP)

Patient's systolic blood pressure (SBP)

Time frame: Four hours after caesarean delivery

systolic blood pressure (SBP)

Patient's systolic blood pressure (SBP)

Time frame: Eight hours after caesarean delivery

systolic blood pressure (SBP)

Patient's systolic blood pressure (SBP)

Time frame: Twelve hours after caesarean delivery

systolic blood pressure (SBP)

Patient's systolic blood pressure (SBP)

Time frame: Twenty-four hours after caesarean delivery

systolic blood pressure (SBP)

Patient's systolic blood pressure (SBP)

Time frame: Forty-eight hours after caesarean delivery

diastolic blood pressure (DBP)

Patient's diastolic blood pressure (DBP)

Time frame: Two hours after caesarean delivery

diastolic blood pressure (DBP)

Patient's diastolic blood pressure (DBP)

Time frame: Four hours after caesarean delivery

diastolic blood pressure (DBP)

Patient's diastolic blood pressure (DBP)

Time frame: Eight hours after caesarean delivery

diastolic blood pressure (DBP)

Data from ClinicalTrials.gov

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Patient's diastolic blood pressure (DBP)

Time frame: Twelve hours after caesarean delivery

diastolic blood pressure (DBP)

Patient's diastolic blood pressure (DBP)

Time frame: Twenty-four hours after caesarean delivery

diastolic blood pressure (DBP)

Patient's diastolic blood pressure (DBP)

Time frame: Forty-eight hours after caesarean delivery

heart rate (HR)

Patient's heart rate (HR)

Time frame: Two hours after caesarean delivery

heart rate (HR)

Patient's heart rate (HR)

Time frame: Four hours after caesarean delivery

heart rate (HR)

Patient's heart rate (HR)

Time frame: Eight hours after caesarean delivery

heart rate (HR)

Patient's heart rate (HR)

Time frame: Twelve hours after caesarean delivery

heart rate (HR)

Patient's heart rate (HR)

Time frame: Twenty-four hours after caesarean delivery

heart rate (HR)

Patient's heart rate (HR)

Time frame: Forty-eight hours after caesarean delivery

Blood oxygen saturation (SpO2)

Measurement of pulse Blood oxygen saturation (SpO2) in parturients

Time frame: Two hours after caesarean delivery

Blood oxygen saturation (SpO2)

Measurement of pulse Blood oxygen saturation (SpO2) in parturients

Time frame: Four hours after caesarean delivery

Blood oxygen saturation (SpO2)

Measurement of pulse Blood oxygen saturation (SpO2) in parturients

Time frame: Eight hours after caesarean delivery

Blood oxygen saturation (SpO2)

Measurement of pulse Blood oxygen saturation (SpO2) in parturients

Time frame: Twelve hours after caesarean delivery

Blood oxygen saturation (SpO2)

Measurement of pulse Blood oxygen saturation (SpO2) in parturients

Time frame: Twenty-four hours after caesarean delivery

Blood oxygen saturation (SpO2)

Measurement of pulse Blood oxygen saturation (SpO2) in parturients

Time frame: Forty-eight hours after caesarean delivery

Adverse events

Adverse events that occurred after the administration of study drugs were also recorded.

Time frame: within Forty-eight hours of surgery