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

NCT06985992 | Not Yet Recruiting

• 1 other identifier: 2025/04-05
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Caesarean Section

Keywords

Caesarean section; morphine; dexamethasone; nausea-vomiting; postoperative complications

Outcome Measures

Primary Outcomes (2)

• Postoperative nausea-vomiting

  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.

  For 24 hours after surgery

• Postoperative itching

  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.

  For 24 hours after surgery

Secondary Outcomes (2)

• Intraoperative Mean Blood Pressure

  Intraoperatively every 5 minutes

• Intraoperative Heart Rate

  Intraoperatively every 5 minutes

Study Arms (2)

Group morfin

ACTIVE COMPARATOR

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.

Procedure: Group morphine

Group morfin+dexamethasone

EXPERIMENTAL

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.

Procedure: Group morfin+dexamethasone

Interventions

Group morphine PROCEDURE

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

Also known as: Group I

Group morfin

Group morfin+dexamethasone PROCEDURE

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

Also known as: Group II

Group morfin+dexamethasone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• st and 2nd caesarean sections

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Related Publications (3)

• Ankouni T, Kanawati S, El Khatib R, El Hassan J, Itani SE, Rajab O, Naja Z. Ondansetron versus ondansetron with dexamethasone to prevent intrathecal-morphine pruritus for caesarean patients: randomised double-blind trial. J Obstet Gynaecol. 2021 Oct;41(7):1080-1086. doi: 10.1080/01443615.2020.1852538. Epub 2021 Mar 2.

  PMID: 33650930 BACKGROUND

• Nasiri A, Abutorabi SM, Sane S. Intrathecal dexamethasone-bupivacaine combination with bupivacaine alone in spinal anesthesia for cesarean delivery. Caspian J Intern Med. 2024 Summer;15(3):414-420. doi: 10.22088/cjim.15.3.414.

  PMID: 39011433 BACKGROUND

• Ahmed SA, Lotfy HA, Mostafa TAH. The effect of adding dexmedetomidine or dexamethasone to bupivacaine-fentanyl mixture in spinal anesthesia for cesarean section. J Anaesthesiol Clin Pharmacol. 2024 Jan-Mar;40(1):82-89. doi: 10.4103/joacp.joacp_396_22. Epub 2024 Mar 14.

  PMID: 38666154 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nurettin KURT, Assoc.Prof

  YüzüncüYıl

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurettin KURT, assoc.Prof.

CONTACT

+90 4322150473; dr.nurettinkurt@gmail.com

Nurettin KURT, assoc.Prof.

CONTACT

+90 05445262921; dr.nurettinkurt@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Spinal anesthesia will be administered to 120 pregnant patients scheduled for elective cesarean section, using either a combination of 2 mL (10 mg) bupivacaine, 0.1 mL (100 mcg) morphine, and 0.5 mL saline, or a combination of 2 mL (10 mg) bupivacaine, 0.1 mL (100 mcg) morphine, and 0.5 mL (2 mg) dexamethasone, depending on the group to which they are randomized.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 10 months
• Access Criteria: The access can be provided via the e-mail addresses below dr.nurettinkurt@gmail.com