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

Not Applicable

Completed

• Conditions: Postoperative Analgesia; Spinal Anesthesia; Cesarean Section
• Interventions: Drug: 80 mcg intrathecal morphine; Drug: 160 mcg intrathecal morphine; Drug: 120 mcg intrathecal morphine

• Registration Number: NCT05317572
• Lead Sponsor: Ondokuz Mayıs University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-10-01
• Primary Completion: 2019-01-01
• Study Completion: 2020-09-01
• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-30
• Status Verified: 2022-04
• Study First Posted: 2022-04-08
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Fentanyl consumption in the first 24 hours after surgery	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 Outcome Measures

Name	Time	Method
The incidences of post-operative nausea and vomiting (PONV)	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.
The incidence of side effects related to opioid use	Postoperative Day 2	Complications related to opioid use such as pruritus, fatigue, sedation or respiratory depression was recorded
Post-operative acute pain	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.
APGAR score	The 5th minute APGAR score was recorded.	The 5th minute APGAR score was recorded.
Bromage Score Comparison	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.

Trial Locations

Locations (1)

Ondokuz Mayıs University Faculty of Medicine; 🇹🇷 Samsun, Turkey