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

NCT05317572 | Completed

• 1 other identifier: CSITM2020
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Spinal Anesthesia; Postoperative Analgesia

Keywords

Postoperative pain; Intrathecal morphine

Outcome Measures

Primary Outcomes (1)

• Fentanyl consumption in the first 24 hours after surgery

  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 Outcomes (5)

• Post-operative acute pain

  Postoperative Day 2

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

  Postoperative Day 2

• The incidence of side effects related to opioid use

  Postoperative Day 2

• Bromage Score Comparison

  Postoperative 2nd hour.

• APGAR score

  The 5th minute APGAR score was recorded.

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Group 1: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 80 mcg intrathecal morphine) + iv Fentanyl-PCA

Drug: 80 mcg intrathecal morphine

Group 2

ACTIVE COMPARATOR

Group 2: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 120 mcg intrathecal morphine) + iv Fentanyl-PCA

Drug: 120 mcg intrathecal morphine

Group 3

ACTIVE COMPARATOR

Group 3: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 160 mcg intrathecal morphine) + iv Fentanyl-PCA

Drug: 160 mcg intrathecal morphine

Interventions

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.

Group 1

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.

Group 2

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.

Group 3

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University Faculty of Medicine

Samsun, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 9952150 RESULT

• 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.

  PMID: 7008655 RESULT

• 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.

  PMID: 29310376 RESULT

• 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.

  PMID: 12145067 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• ilke tamdoğan

  Ondokuz Mayıs University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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, groups were determined at a ratio of 1:1:1 . Sealed and sequentially numbered envelopes were created. One hour before the operation, an experienced anesthesiologist, who was not involved in the intraoperative and postoperative follow-up of the patient and would only perform the spinal anesthesia procedure, opened a sealed opaque sealed envelope to learn the group that the patient would be included in. There were two different physicians who performed intraoperative and postoperative follow-up. Both of the follow-up physicians were blind to the patient group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: 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,

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: April 8, 2022
• Study Start: October 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: September 1, 2020
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

TU (1)