Clinical trial NCT05317572: Comparison of Three Different Doses of Intrathecal Morphine for Analgesia After Cesarean Section
Official title: Comparison of Three Different Doses of Intrathecal Morphine for Analgesia After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Spinal Anesthesia
Postoperative Analgesia
Keywords: Postoperative pain
Intrathecal morphine
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients were randomly divided into three groups of 50patients each. In the system where computer generated random numbers (SPSS v23.0, IBM,- Page 2 of 6 \[DRAFT\] -NewYork, USA) were used,
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fentanyl consumption in the first 24 hours after surgery
timeFrame: Postoperative Day 2
Secondary outcomes:
measure: Post-operative acute pain
timeFrame: Postoperative Day 2
measure: The incidences of post-operative nausea and vomiting (PONV)
timeFrame: Postoperative Day 2
measure: The incidence of side effects related to opioid use
timeFrame: Postoperative Day 2
measure: Bromage Score Comparison
timeFrame: Postoperative 2nd hour.
measure: APGAR score
timeFrame: The 5th minute APGAR score was recorded.
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University Faculty of Medicine
Study officials:
affiliation: Ondokuz Mayıs University Faculty of Medicine
name: ilke tamdoğan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.