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Not yet recruitingNCT06985992Updated May 29, 2025

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

An interventional study of Group morphine and Group morfin+dexamethasone in Caesarean Section, sponsored by Yuzuncu Yıl University. Not yet recruiting. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-29.

Sponsored by Yuzuncu Yıl University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Caesarean Section

Keywords

  • Caesarean section
  • morphine
  • dexamethasone
  • nausea-vomiting
  • postoperative complications
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Group morfin

    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

  • Experimental
    Group morfin+dexamethasone

    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

  • ProcedureGroup morphine

    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

  • ProcedureGroup morfin+dexamethasone

    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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: For 24 hours after surgery

  2. 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.

    Time frame: For 24 hours after surgery

Secondary outcomes

  1. Intraoperative Mean Blood Pressure

    Mean blood pressure will be measured every 5 minutes intraoperatively using a noninvasive method.

    Time frame: Intraoperatively every 5 minutes

  2. Intraoperative Heart Rate

    Heart rate will be measured every 5 minutes intraoperatively using a noninvasive method

    Time frame: Intraoperatively every 5 minutes

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 33650930 ↗
  • 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. PubMed 39011433 ↗
  • 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. PubMed 38666154 ↗

Individual participant data

Plan to share: Yes — Study protocol anda statistical analysis plan will be share with other researchers

Supporting information: Study protocol, Sap

08

Registry details

Key details

Study ID
NCT06985992
Lead sponsor
Yuzuncu Yıl University
Responsible party
Nurettin KURT (Assistant Professor, Yuzuncu Yıl University) — Principal investigator
First posted
May 22, 2025
Start date
Jul 1, 2025 (estimated)
Primary completion
Oct 1, 2025 (estimated)
Completion
Nov 1, 2025 (estimated)
Last update
May 29, 2025

Study contacts

Nurettin KURT, assoc.Prof.
Contact
dr.nurettinkurt@gmail.com
+90 4322150473
Nurettin KURT, assoc.Prof.
Contact
dr.nurettinkurt@hotmail.com
+90 05445262921
Nurettin KURT, Assoc.Prof
principal investigator · YüzüncüYıl

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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