- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05317572
Comparison of Three Different Doses of Intrathecal Morphine for Analgesia After Cesarean Section
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Samsun, Turkey
- Ondokuz Mayıs University Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
Group 1: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 80 mcg intrathecal morphine) + iv Fentanyl-PCA
|
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. |
Active Comparator: Group 2
Group 2: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 120 mcg intrathecal morphine) + iv Fentanyl-PCA
|
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. |
Active Comparator: Group 3
Group 3: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 160 mcg intrathecal morphine) + iv Fentanyl-PCA
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Postoperative Day 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Postoperative Day 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.
|
Postoperative Day 2
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The incidence of side effects related to opioid use
Time Frame: Postoperative Day 2
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Complications related to opioid use such as pruritus, fatigue, sedation or respiratory depression was recorded
|
Postoperative Day 2
|
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.
|
Postoperative 2nd hour.
|
APGAR score
Time Frame: The 5th minute APGAR score was recorded.
|
The 5th minute APGAR score was recorded.
|
The 5th minute APGAR score was recorded.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ilke tamdoğan, Ondokuz Mayıs University Faculty of Medicine
Publications and helpful links
General Publications
- Palmer CM, Emerson S, Volgoropolous D, Alves D. Dose-response relationship of intrathecal morphine for postcesarean analgesia. Anesthesiology. 1999 Feb;90(2):437-44. doi: 10.1097/00000542-199902000-00018. Erratum In: Anesthesiology 1999 Apr;90(4):1241.
- Baraka A, Noueihid R, Hajj S. Intrathecal injection of morphine for obstetric analgesia. Anesthesiology. 1981 Feb;54(2):136-40. doi: 10.1097/00000542-198102000-00007.
- Weigl W, Bierylo A, Wielgus M, Krzemien-Wiczynska S, Kolacz M, Dabrowski MJ. Perioperative analgesia after intrathecal fentanyl and morphine or morphine alone for cesarean section: A randomized controlled study. Medicine (Baltimore). 2017 Dec;96(48):e8892. doi: 10.1097/MD.0000000000008892.
- Sarvela J, Halonen P, Soikkeli A, Korttila K. A double-blinded, randomized comparison of intrathecal and epidural morphine for elective cesarean delivery. Anesth Analg. 2002 Aug;95(2):436-40, table of contents. doi: 10.1097/00000539-200208000-00037.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSITM2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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