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
The Efficacy of Intrathecal Morphine Versus Intrathecal Morphine+Dexamethasone Combination added to bupivacaine in elective cesarean section under spinal anesthesia
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.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's planned enrollment of 120 is close to the median of 114 across 766 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: 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
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+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
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
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
Intraoperative Mean Blood Pressure
Mean blood pressure will be measured every 5 minutes intraoperatively using a noninvasive method.
Time frame: Intraoperatively every 5 minutes
Intraoperative Heart Rate
Heart rate will be measured every 5 minutes intraoperatively using a noninvasive method
Time frame: Intraoperatively every 5 minutes
No study locations are listed for this record.
Plan to share: Yes — Study protocol anda statistical analysis plan will be share with other researchers
Supporting information: Study protocol, Statistical analysis plan
Time frame: 10 months
Access criteria: The access can be provided via the e-mail addresses below dr.nurettinkurt@gmail.com
Start is estimated for Jul 2025; primary completion for Oct 2025, 3 months later.
Of 391 non-industry interventional studies with no phase under Postoperative Complications, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's planned 3 months is below that.
Counting every sponsor, half of 395 studies reached it within 21 months; a quarter within 8 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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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