The Efficacy of Intrathecal Morphine Versus Intrathecal Morphine-Dexamethasone Combination in Cesarean Delivery

Yuzuncu Yıl University

Status: Begins enrollment this month

Conditions: Caesarean Section

Treatments: Procedure: Group morfin+dexamethasone; Procedure: Group morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT06985992

2025/04-05

Details and patient eligibility

About

The Efficacy of Intrathecal Morphine Versus Intrathecal Morphine+Dexamethasone Combination added to bupivacaine in elective cesarean section under spinal anesthesia

Full description

The study will be designed as a double-blind, randomized clinical trial and will be conducted following approval by the local ethics committee. A total of 120 patients, aged 18-40 years, with an ASA physical status of II and scheduled for elective cesarean section, will be included. All patients will undergo standard preparation for spinal anesthesia. Two large-bore intravenous lines will be inserted in each patient upon arrival in the operating room. Participants will be randomly assigned to one of two groups (n = 60 per group) using sealed opaque envelopes.

Group I (morphine group) will receive spinal anesthesia consisting of 2 mL (10 mg) bupivacaine, 0.1 mL (100 mcg) morphine, and 0.5 mL saline.

Group II (morphine+dexamethasone group) will receive a mixture of 2 mL (10 mg) bupivacaine, 0.1 mL (100 mcg) morphine, and 0.5 mL (2 mg) dexamethasone.

Intraoperative hemodynamic parameters (including age, height, and weight), ASA scores, postoperative complications (such as nausea, vomiting, and pruritus), and postoperative pain levels will be recorded and analyzed.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients scheduled for caesarean sections
• Between 18-40 years
• ASA II group
• Those who will undergo spinal anesthesia
• Those between 35-40 weeks of pregnancy
• 1st and 2nd caesarean sections

Exclusion criteria

• Those who prefer general anesthesia
• Those who are outside the age range of 18-40
• Those who are ASA III and above
• Those with HT, DM, cardiac and respiratory diseases
• Preeclampsia, eclampsia, HELLP
• Those with a history of drug use that affects the cardiovascular system
• Placenta Previa, Placenta Acreta, Placenta Acreta Those with a history of antiemetic or antidepressant drug use

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Group morfin

Active Comparator group

Description:

Group Morphine: Spinal anesthesia will be applied to patients who will undergo caesarean section using a combination of 2 ml (10 mg) bupivacaine + 0.1 ml (100 mcg) morphine + 0.5 ml saline.

Treatment:

Procedure: Group morphine

Group morfin+dexamethasone

Experimental group

Description:

Group morfin+dexamethasone: Spinal anesthesia will be applied to patients who will undergo a caesarean section using a combination of 2 ml (10 mg) bupivacaine + 0.1 ml (100 mcg) morphine + 0.5 ml (2 mg) dexamethasone.

Treatment:

Procedure: Group morfin+dexamethasone