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NCT Number: NCT06985992

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

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

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group morphine

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

Other names: Group I

Group morfin+dexamethasone

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

Other names: Group II

Primary outcomes

  1. 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.

  2. 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

  1. Intraoperative Mean Blood Pressure

    Time frame: Intraoperatively every 5 minutes

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

  2. Intraoperative Heart Rate

    Time frame: Intraoperatively every 5 minutes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Nurettin KURT, assoc.Prof.

CONTACT

[email protected]

+90 4322150473

Nurettin KURT, assoc.Prof.

CONTACT

[email protected]

+90 05445262921

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

The Efficacy of Intrathecal Morphine Versus Intrathecal Morphine-Dexamethasone Combination in Cesarean Delivery: A Prospective Randomized Double-Blind Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 22, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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