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NCT Number: NCT05317572

Comparison of Three Different Doses of Intrathecal Morphine for Analgesia After Cesarean Section

In our study, It was aimed to determine the dose of morphine that provides the most effective analgesia with the least incidence of side effects in the postoperative period.

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Key information

Conditions

Cesarean Section Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Analgesia Postoperative Complications Signs and Symptoms Spinal Anesthesia

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University Faculty of Medicine

Samsun, Turkey (Türkiye)

About this study

Spinal anesthesia is a widely used method in cesarean section operations. It has become a popular practice to add opioids to local anesthetic agents to improve the quality and prolong the duration of intraoperative and postoperative analgesia. Morphine and fentanyl are commonly used opioids for this purpose. In cesarean sections, intrathecal morphine (ITM) is preferred for postoperative analgesia due to its slow onset and long-term analgesia, and intrathecal fentanyl is preferred for intraoperative analgesia due to its faster onset of action.

ITM can cause side effects such as nausea, vomiting, itching, sedation and respiratory depression. The quality of analgesia and the incidence of side effects may vary depending on the ITM dose used. There are studies indicating that reducing the dose of ITM results in good quality, long-term analgesia with a low incidence of side effects. However, the ideal dose of ITM providing optimal postoperative analgesia with the lowest incidence of side effects for cesarean section has not been determined yet in the literature. For this purpose, in this study it was compared the postoperative analgesia efficiency and incidence of side effects of three different ITM doses in order to contribute to the literature.

Patients were divided into three groups:

Group 1: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 80 mcg intrathecal morphine was administered.

Group 2: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 120 mcg intrathecal morphine was administered.

Group 3: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 160 mcg intrathecal morphine was administered.

All patients received iv Patient Controlled Analgesia (PCA) prepared with fentanyl postoperatively.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient undergoing cesarean section
  • Between the ages of 18-40,
  • ASA II,
  • Pregnant women with gestational week > 36

Exclusion criteria

  • Not accepting regional anesthesia,
  • İnfection at the injection site,
  • Coagulopathy, bleeding diathesis,
  • Severe hypovolemia,
  • İncrease in intracranial pressure,
  • Pregnant women with problems such as severe aortic stenosis, severe mitral stenosis for which spinal anesthesia is contraindicated,
  • Patients with a history of allergy to any drug included in the study protocol

Treatment and study plan

80 mcg intrathecal morphine

Drug

İntraoperative Management:

Spinal anesthesia was administered to each patient in a sitting position, after aseptic conditions were achieved with a midline approach. A 25 gauge pencil point spinal needle was placed in the L3-4 or L4-5 space. Upon aspiration of clear cerebrospinal fluid (CSF), 10 mg of hyperbaric bupivacaine, 20 mcg of fentanyl and 80 micrograms of morphine were injected into the intrathecal space together with the determined morphine doses.

Postoperative analgesia management:

Diclofenac sodium 2 × 75 mg was administered intramuscularly to all patients. All patients received iv Patient Controlled Analgesia (PCA) prepared with fentanyl postoperatively. For patients with pain VAS score of 5 or more, meperidine was administered at a rate of 25 mg each time and with a total daily dose of 200 mg.

120 mcg intrathecal morphine

Drug

İntraoperative Management:

Spinal anesthesia was administered to each patient in a sitting position, after aseptic conditions were achieved with a midline approach. A 25 gauge pencil point spinal needle was placed in the L3-4 or L4-5 space. Upon aspiration of clear cerebrospinal fluid (CSF), 10 mg of hyperbaric bupivacaine, 20 mcg of fentanyl and 120 micrograms of morphine were injected into the intrathecal space together with the determined morphine doses.

Postoperative analgesia management:

Diclofenac sodium 2 × 75 mg was administered intramuscularly to all patients. All patients received iv Patient Controlled Analgesia (PCA) prepared with fentanyl postoperatively. For patients with pain VAS score of 5 or more, meperidine was administered at a rate of 25 mg each time and with a total daily dose of 200 mg.

160 mcg intrathecal morphine

Drug

İntraoperative Management:

Spinal anesthesia was administered to each patient in a sitting position, after aseptic conditions were achieved with a midline approach. A 25 gauge pencil point spinal needle was placed in the L3-4 or L4-5 space. Upon aspiration of clear cerebrospinal fluid (CSF), 10 mg of hyperbaric bupivacaine, 20 mcg of fentanyl and 160 mcg of morphine were injected into the intrathecal space together with the determined morphine doses.

Postoperative analgesia management:

Diclofenac sodium 2 × 75 mg was administered intramuscularly to all patients. All patients received iv Patient Controlled Analgesia (PCA) prepared with fentanyl postoperatively. For patients with pain VAS score of 5 or more, meperidine was administered at a rate of 25 mg each time and with a total daily dose of 200 mg.

Primary outcomes

  1. Fentanyl consumption in the first 24 hours after surgery

    Time frame: Postoperative Day 2

    Fentanyl consumption in the first 24 hours was measured. Patients were able to request opioids via a PCA device when their VAS score is above 4 at rest and during activity (coughing and walking).

Secondary outcomes

  1. Post-operative acute pain

    Time frame: Postoperative Day 2

    Pain status at rest and while activity (coughing and walking) was assessed by VAS scores at 0, 8, 24, 30, and 48 hours after surgery. The VAS is an 11-point numeric scale which ranges from 0 to 10 at rest and during activity.

  2. The incidences of post-operative nausea and vomiting (PONV)

    Time frame: Postoperative Day 2

    The severity of postoperative nausea and vomiting (PONV) was assessed using a Numeric rating scale(NRS) at 0, 8, 24, 30, and 48 hours after surgery. If a score of 3 or more is recorded, ondansetron 0,1 mg/kg iv was administered.

  3. The incidence of side effects related to opioid use

    Time frame: Postoperative Day 2

    Complications related to opioid use such as pruritus, fatigue, sedation or respiratory depression was recorded

  4. Bromage Score Comparison

    Time frame: Postoperative 2nd hour.

    After spinal anesthesia was administered, motor block was evaluated according to the Bromage scale. Bromage score and motor block removal times were noted at the intraoperative 5th, 30th minutes, at the end of the operation, at the postoperative 30th minute and at the 2nd hour.

  5. APGAR score

    Time frame: The 5th minute APGAR score was recorded.

    The 5th minute APGAR score was recorded.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Apr 8, 2022
Registry last updated
Apr 15, 2022

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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