Prevalence of Insufficient Analgesia in Caesarean Section Under Neuroaxial Anesthesia (PAICAN)

NCT06824740 | Completed

• 1 other identifier: PAICAN
• Study Type: observational
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

Pain during caesarean section under neuraxial anesthesia is often underestimated and could be related to perinatal psycholocal disorders. The implementation of an evidence-based anesthestic management protocol for caesarean sections aims at reducing intraoperative and postoperative pain. This prospective observational single-center study aims at determining whether this protocol helped to reduce the prevalence of insufficient analgesia in during caesarean sections.

Conditions

Cesarean Section; Analgesia

Keywords

cesarean section; neuraxial anesthesia; pain; analgesia

Outcome Measures

Primary Outcomes (1)

• Prevalence of Insufficient Analgesia during cesarean section

  Prevalence of Insufficient Analgesia during cesarean section is a composite variable based on 4 principal variables: * Intraoperative Verbal Numeric Scale of Pain (asked intraoperatively) * Categorical scale of pain (low, moderate, severe, no pain) (asked intraoperatively) * Alternative anesthestic plan (any different anesthetic technique that differs from the initial anesthestic plan) * Failure of the initial anesthetic technique (any failure during the whole surgical procedure)

  During the cesarean section

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women undergoing a caesarean section under neuraxial anesthesia in a tertiary hospital in Barcelona (Spain).

You may qualify if:

• \- Pregnant women aged 18 or more undergoing a caesarean section under neuraxial anesthesia

You may not qualify if:

• Non pregnant women
• Women under 18 years old
• General anesthesia as first option for anesthesia
• Refusal to participate in the study
• Women with cognitive impairment or held in an institution by legal or official order

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Adriana Vilches, MD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: March 3, 2024
• Primary Completion: January 6, 2025
• Study Completion: January 25, 2025
• Last Updated: April 15, 2025

Record last verified: 2024-05

Locations

ES (1)