Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery

NCT06355271 | Recruiting DMC

• 1 other identifier: 2024-00019
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Based on randomization, patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery

Conditions

Obstetric Pain

Keywords

Cesarean section; Fentanyl; Functional Recovery

Outcome Measures

Primary Outcomes (2)

• Patient Controlled Analgesia morphine consumption

  Patient Controlled Analgesia morphine consumption in the first 24 postoperative hours

  Day 1 after cesarean section

• obstetric quality of recovery score

  obstetric quality of recovery score (ObsQoR-11)

  Day 1 after cesarean section

Secondary Outcomes (7)

• Visual Analogue Scale

  Day 1 after cesarean section

• pruritus

  Day 1 after cesarean section (and day 0 for intraoperative pruritus)

• nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity

  Day 1 after cesarean section (and day 0 for intraoperative nausea and vomiting)

• intraoperative hypotension

  during the cesarean section

• intraoperative opioids

  during the cesarean section

Study Arms (3)

Control

ACTIVE COMPARATOR

Spinal anesthesia with no fentanyl

Procedure: Fentanyl 1

Experimental 1

EXPERIMENTAL

Spinal anesthesia with 10 mcg of fentanyl

Procedure: Fentanyl2

Experimental 2

EXPERIMENTAL

Spinal anesthesia with 20 mcg of fentanyl

Procedure: Fentanyl 3

Interventions

Fentanyl 1 PROCEDURE

Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and no fentanyl

Control

Fentanyl2 PROCEDURE

Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and 10 mcg of of fentanyl

Experimental 1

Fentanyl 3 PROCEDURE

Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and 20 mcg of fentanyl

Experimental 2

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: the study involves pregnant patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients over 18 year of age
• height over 160 cm
• American Society Anesthesiologists physical status I and II
• term singleton parturients
• scheduled for elective cesarean delivery during spinal anesthesia at Ospedale Regionale Bellinzona Valli

You may not qualify if:

• patients with inability to consent
• patient refusal
• contraindication to spinal anesthesia (eg, hemodynamic instability, infection at the surgery site, and neurologic defects such as transverse myelitis)
• emergency cesarean delivery
• preeclampsia/eclampsia
• allergy to drugs used in the protocol

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

Ospedale Regionale di Bellinzona, San Giovanni

Bellinzona, Switzerland

RECRUITING

MeSH Terms

Conditions

Labor Pain

Interventions

3-methylfentanyl

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Roberto Dossi

CONTACT

0918119341; roberto.dossi@eoc.ch

Alessandra Lauretta

CONTACT

0918118182; alessandra.lauretta@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Allocation will take place immediately before the intervention by the means of access to centralized, real-time allocation through a computer program. The identification code will be present on the data collection form (where the patient's name, surname or date of birth will not appear to ensure blinding of the study). Personnel not directly involved with patient care, present during the randomization process, will sterilely prepare anesthesia solution while maintaining a total volume of 3,1 ml. This will allow blinding of patients, care providers and data collectors. The procedure will take place as a common clinical practice in our center. When performing spinal anesthesia, sterility is of fundamental importance, so it will not be possible to have the syringe used tagged. In the kit all materials will be sterile
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Med.

Model Details: Single center, multiple-blind, prospective, randomized, controlled trial in 3 parallel groups

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 9, 2024
• Study Start: June 12, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)