Postoperative Analgesic Effect of Esketamine

Xuanhan County People's Hospital

Status: Completed

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

Treatments: Drug: 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate; Drug: 2 mg morphine sulfate; Drug: 0.25mg/kg esketamine; Drug: 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT05582135

XuanhanCo

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: Female

Ages: 20 to 32 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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119 participants in 4 patient groups

group A

Active Comparator group

Description:

The parturients in group A were administered 2 mg morphine sulfate through the epidural catheter.

Treatment:

Drug: 2 mg morphine sulfate

group B

Active Comparator group

Description:

The parturients in group B were administered 0.25mg/kg of esketamine.

Treatment:

Drug: 0.25mg/kg esketamine

group C

Active Comparator group

Description:

The parturients in group C were administered 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate.

Treatment:

Drug: 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate

group D

Active Comparator group

Description:

The parturients in group D were administered 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate.

Treatment:

Drug: 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate