Pain Control and Side Effects in Cesarean Section Anesthesia: Comparison of Intrathecal Morphine and Fentanyl

NCT07144410 | Active Not Recruiting

• 1 other identifier: 08FvM_Medical Study
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Intrathecal opioids are frequently combined with local anesthetics to optimize spinal anesthesia for cesarean delivery. Fentanyl, a lipophilic opioid, offers rapid onset and enhanced intraoperative analgesia. However, its postoperative analgesic duration is limited, but in contrast, morphine, a hydrophilic opioid, provides prolonged postoperative pain control but has a slower onset and a higher incidence of adverse effects, notably nausea and vomiting. This prospective, randomized, double-blind, parallel study enrolled 180 parturients scheduled for elective cesarean section, all receiving spinal anesthesia with hyperbaric bupivacaine (7.5-10 mg, adjusted to height) plus either intrathecal fentanyl 25 µg (F group) or intrathecal morphine 100 µg and fentanyl 25µg (M+F group). Primary outcomes include intraoperative and postoperative pain scores, systemic opioid consumption, and patient satisfaction, while secondary outcomes assess the incidence of opioid-related side effects.

Conditions

Anaesthesia, Spinal

Keywords

spinal anaesthesia; elective caesarean section; intrathecal opioids; fentanyl; morphine; opioids side effects; analgesia; fentanyl and morphine

Outcome Measures

Primary Outcomes (2)

• Assessing the perioperative analgesic efficacy

  Pain intensity will be evaluated using the Numeric Pain Scale, with scores obtained at the time of skin incision, at the end of surgery, and at 4h, 6h, 12h, 24h, 48h, and 72 hours postoperatively; AUE72h (sum pain intensity differences area over 72 hours) and SPID72h (time-weighted sum pain intensity differences over 72 hours). Assessments will be conducted both at rest and during mobilization. The pain scores according to the Numeric Pain Scale will be rated between 0 and 10, meaning 0 - no pain and 10 - the worst pain imaginable

  6 months

• Assessing the degree of patient's satisfaction

  Assessing the degree of satisfaction on a five point scale with the highest rate as being "completely satisfied", followed by "satisfied", "so so", "unsatisfied" and "completely unsatisfied"

  6 months

Secondary Outcomes (2)

• Incidence of Additional Opioid-Related Adverse Effects

  6 months

• Incidence and Severity of Pruritus

  6 months

Study Arms (2)

Fentanyl, Morphine and Bupivacaine

Pregnant patients scheduled for C-section that received a spinal anaesthesia mixture of Fentanyl, Morphine and Bupivacaine

Drug: fentanyl + morphine

Fentanyl and Bupivacaine

Pregnant patients scheduled for C-section that received a spinal anaesthesia mixture of Fentanyl and Bupivacaine

Drug: fentanyl

Interventions

fentanyl + morphine DRUG

The purpose of the trial is to study the quality of anaesthesia and perioperative analgesia provided by fentanyl, morphine and bupivacaine versus fentanyl and bupivacaine, as well as their side effects.

Also known as: plus bupivacaine

Fentanyl, Morphine and Bupivacaine

fentanyl DRUG

The purpose of the trial is to study the quality of anaesthesia and perioperative analgesia provided by fentanyl, morphine and bupivacaine versus fentanyl and bupivacaine, as well as their side effects.

Also known as: plus bupivacaine

Fentanyl and Bupivacaine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The subjects of the study will be selected from the pregnant patients of Oradea Pelican Clinic Hospital.

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status class I-II.
• Absence of significant past medical conditions.
• No documented hypersensitivity to any study drug.
• No history of chronic pain syndromes or regular analgesic consumption.
• No anxiety or depressive disorders diagnosis.
• Body weight ≥ 50 kg.
• Scheduled for elective cesarean delivery.
• Single fetus.

You may not qualify if:

• Patient refusal.
• Contraindication of spinal anaesthesia.
• Conversion from a natural delivery with or without an epidural anaesthesia started.
• History of substance abuse or drug dependence.
• Presence of acute or chronic fetal distress.
• Preeclampsia.
• Allergic reaction occurring after enrollment.
• Refusal to receive protocol-specified analgesics or medications.
• Requirement for surgical re-intervention within 72 hours postoperatively.
• Previous administration of opioids or other central nervous system depressants prior to intervention.

Sponsors & Collaborators

• University of Oradea: lead
• Oradea Pelican Clinic Hospital: collaborator

Study Sites (1)

University of Oradea, Pelican Clinic Hospital

Oradea, Bihor County, 410505, Romania

Location

MeSH Terms

Conditions

Agnosia

Interventions

Fentanyl; Morphine; Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Aurel Mohan, MD, PhD

  Head of Surgery Department of Medicine and Pharmacy Faculty of Oradea

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 27, 2025
• Study Start: August 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

RO (1)