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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-11-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Caesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Group morphine

Intervention Type 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

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.

Group Type EXPERIMENTAL

Group morfin+dexamethasone

Intervention Type 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

Interventions

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Group 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

Intervention Type PROCEDURE

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 Type PROCEDURE

Other Intervention Names

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Group I Group II

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes