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

O

Ondokuz Mayıs University

Status

Completed

Conditions

Postoperative Analgesia
Cesarean Section
Spinal Anesthesia

Treatments

Drug: 80 mcg intrathecal morphine
Drug: 160 mcg intrathecal morphine
Drug: 120 mcg intrathecal morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT05317572
CSITM2020

Details and patient eligibility

About

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.

Full description

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.

Enrollment

150 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 3 patient groups

Group 1
Active Comparator group
Description:
Group 1: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 80 mcg intrathecal morphine) + iv Fentanyl-PCA
Treatment:
Drug: 80 mcg intrathecal morphine
Group 2
Active Comparator group
Description:
Group 2: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 120 mcg intrathecal morphine) + iv Fentanyl-PCA
Treatment:
Drug: 120 mcg intrathecal morphine
Group 3
Active Comparator group
Description:
Group 3: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 160 mcg intrathecal morphine) + iv Fentanyl-PCA
Treatment:
Drug: 160 mcg intrathecal morphine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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