The Efficacy of Intrathecal Morphine Versus Intrathecal Morphine-Dexamethasone Combination in Cesarean Delivery: A Prospective Randomized Double-Blind Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- Postoperative nausea-vomiting
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- 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
- •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
Arms & Interventions
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.
Intervention: Group morfin+dexamethasone (Procedure)
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.
Intervention: Group morphine (Procedure)
Outcomes
Primary Outcomes
Postoperative nausea-vomiting
Time Frame: 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
Time Frame: 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 Outcomes
- Intraoperative Mean Blood Pressure(Intraoperatively every 5 minutes)
- Intraoperative Heart Rate(Intraoperatively every 5 minutes)
Investigators
Nurettin KURT
Assistant Professor
Yuzuncu Yıl University