Postoperative PainNCT02033304
Factors Predicting Postoperative Cesarean Section Pain
An observational study of Postoperative Pain, run by Rabin Medical Center at 2 sites in Israel.
Trial summary
In spite of identical analgesic protocols, parturients suffer different levels of pain postoperative lay. In this study we hope to identify factors which influence the perception of pain including preoperative anxiety, sleep quality and local anesthesia injection pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- How many people
- 229 participants
- Where
- 2 sitesIsrael
- Study dates
- Feb 2014to Jul 2014
- 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women after cesarean section
Who may be able to join
- Women undergoing spinal anesthesia
Who cannot join
- women unable to cooperate
- Women undergoing general anesthesia
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Beilinson hospital
Petach Tikvah
Rabin medical center
Petach Tikvah
About this study
Official title: Analysis of Factors Predicting Postoperative Pain and Wound Hyperalgesia After Cesarean Section
In spite of identical analgesic protocols, parturients suffer different levels of pain postoperative lay. In this study we hope to identify factors which influence the perception of pain including preoperative anxiety, sleep quality and local anesthesia injection pain.
- Conditions
- Postoperative Pain
- Keywords
- Cesarean section, Pain, Wound hyperalgesia
- Medical subject headings
- Pain, Postoperative, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Measured: Postoperative day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033304
- Sponsor's protocol ID
- 7124
- Status last verified
- Jan 2013
- First submitted
- 9 Jan 2014
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Factors Predicting Postoperative Pain and Wound Hyperalgesia After Cesarean Section
- ClinicalTrials.gov ID
- NCT02033304
- Acronym / sponsor ID
- 7124
- Conditions
- Postoperative Pain
- Keywords
- Cesarean section, Pain, Wound hyperalgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Jan 2014 (estimated)
- 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.
In spite of identical analgesic protocols, parturients suffer different levels of pain postoperative lay. In this study we hope to identify factors which influence the perception of pain including preoperative anxiety, sleep quality and local anesthesia injection pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women after cesarean section
Key inclusion criteria (1 listed)
- Women undergoing spinal anesthesia
Key exclusion criteria (2 listed)
- women unable to cooperate
- Women undergoing general anesthesia
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
Postoperative pain
Time frame: Postoperative day1
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 7 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Rabin Medical Center at 2 sites in Israel.
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 2 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 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Postoperative pain (time frame: Postoperative day1). 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 7 May 2015.