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OpenTrials
Completed

NCT Number: NCT06824740

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

About this study

Caesarean surgery is one of the most frequent surgeries around the world and neuroaxial anesthesia is the preferred anesthesia technique in most settings. Still, many women experience pain during caesarean section, and it has implications in their birth experience. The PAICAN study (Prevalence of Insufficient Analgesia in Caesarean Section under Neuroaxial Anesthesia) aims to study how the implementation of a specific protocol of anesthetic management during caesarean section reduces the intraoperative pain and the need of postoperative painkillers.

Other objectives are:

  • To study the adherence to the new protocol in our centre
  • To understand the mechanisms of the failure of neuraxial anesthesia
  • To study the related factors to insufficient analgesia during surgery (demographic, obstetric, anesthetic, etc.).

Hypothesis: the implementation of an anesthestic management protocol for caesarean sections under neuroaxial anesthesia decreases the prevalence of insufficient analgesia during surgery and in the recovery room.

Design: Prospective observational single-center study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Prevalence of Insufficient Analgesia during cesarean section

    Time frame: During the 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)

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

Prevalence of Insufficient Analgesia in Caesarean Section Under Neuroaxial Anesthesia

Acronym: PAICAN

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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