Cesarean SectionPAICANNCT06824740
Prevalence of Insufficient Analgesia in Caesarean Section Under Neuroaxial Anesthesia (PAICAN)
An observational study of Cesarean Section and Analgesia, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Analgesia
- How many people
- 318 participants
- Where
- 1 siteSpain
- Study dates
- 3 Mar 2024to 25 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women undergoing a caesarean section under neuraxial anesthesia in a tertiary hospital in Barcelona (Spain).
Who may be able to join
- Pregnant women aged 18 or more undergoing a caesarean section under neuraxial anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Insufficient Analgesia in Caesarean Section Under Neuroaxial Anesthesia
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.
Read the detailed description
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.
- Conditions
- Cesarean Section, Analgesia
- Keywords
- cesarean section, neuraxial anesthesia, pain, analgesia
- Medical subject headings
- Agnosia, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During the cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start3 Mar 2024
- Primary completion6 Jan 2025
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriana Vilches, MD, Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824740
- Sponsor's protocol ID
- PAICAN
- Acronym
- PAICAN
- Status last verified
- May 2024
- First submitted
- 7 Feb 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Insufficient Analgesia in Caesarean Section Under Neuroaxial Anesthesia
- ClinicalTrials.gov ID
- NCT06824740
- Acronym / sponsor ID
- PAICAN / PAICAN
- Conditions
- Cesarean Section, Analgesia
- Keywords
- cesarean section, neuraxial anesthesia, pain, analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women undergoing a caesarean section under neuraxial anesthesia in a tertiary hospital in Barcelona (Spain).
Key inclusion criteria (1 listed)
- Pregnant women aged 18 or more undergoing a caesarean section under neuraxial anesthesia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Vilches, MD principal investigator
Hospital del Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section and Analgesia, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Insufficient Analgesia during cesarean section (time frame: During the cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.