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

Not Applicable

Not yet recruiting

• Conditions: Caesarean Section

• Registration Number: NCT06985992
• Lead Sponsor: Yuzuncu Yıl University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Study First Posted: 2025-05-22
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-29
• Study Start: 2025-07-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative nausea-vomiting	For 24 hours after surgery	The incidence of postoperative nausea and vomiting will be scored from 0 to 3. No nausea or vomiting attacks will be graded as 0, a nausea attack that resolves without treatment will be graded as 1, recurrent nausea attacks that resolve with treatment will be graded as 2, and persistent nausea or vomiting attacks will be graded as 3.
Postoperative itching	For 24 hours after surgery	The degree of pruritus will be assessed on a scale of 0 to 3, with 0 being categorized as no pruritus; 1 as mild pruritus; 2 as moderate pruritus; and 3 as severe pruritus.

Secondary Outcome Measures

Name	Time	Method
Intraoperative Mean Blood Pressure	Intraoperatively every 5 minutes	Mean blood pressure will be measured every 5 minutes intraoperatively using a noninvasive method.
Intraoperative Heart Rate	Intraoperatively every 5 minutes	Heart rate will be measured every 5 minutes intraoperatively using a noninvasive method