Clinical trial NCT06985992: The Efficacy of Intrathecal Morphine Versus Intrathecal Morphine-Dexamethasone Combination in Cesarean Delivery
Official title: The Efficacy of Intrathecal Morphine Versus Intrathecal Morphine-Dexamethasone Combination in Cesarean Delivery: A Prospective Randomized Double-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caesarean Section
Keywords: Caesarean section
morphine
dexamethasone
nausea-vomiting
postoperative complications
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative nausea-vomiting
timeFrame: For 24 hours after surgery
measure: Postoperative itching
timeFrame: For 24 hours after surgery
Secondary outcomes:
measure: Intraoperative Mean Blood Pressure
timeFrame: Intraoperatively every 5 minutes
measure: Intraoperative Heart Rate
timeFrame: Intraoperatively every 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: YüzüncüYıl
name: Nurettin KURT, Assoc.Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.