Pain, PostoperativeNCT03205813
Prospective Study of Pain After Spinal Morphine for Cesarean Section and Factors Involved in Moderate to Severe Pain
An observational study of Pain, Postoperative, run by Mahidol University at 1 site in Thailand.
Trial summary
Spinal block with intrathecal morphine is a popular anesthetic technique in cesarean delivery. This technique brings about good maternal and neonatal outcomes as well as provides good postoperative pain control. Systematic review showed intrathecal morphine produced long period of pain control up to 27 hours. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative
- How many people
- 660 participants
- Where
- 1 siteThailand
- Study dates
- 11 Jul 2017to 30 Jan 2020
- 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: Patients undergoing elective cesarean delivery
Who may be able to join
- Age > 18 years
- Elective cesarean section
- Patient accept spinal anesthesia
- ASA classification I-II
- Understand numerical rating scale for pain score
Who cannot join
- Not understand Thai
- Contraindicated in spinal anesthesia with intrathecal morphine
- Complicated pregnancy that general anesthesia may required for cesarean delivery
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Anesthesiology department, Siriraj hospital, Mahidol University
Bangkok, 10700
About this study
Official title: Prospective Study of Pain After Spinal Morphine for Cesarean Section and Analysis of Factors Involved in Moderate to Severe Pain
Spinal block with intrathecal morphine is a popular anesthetic technique in cesarean delivery. This technique brings about good maternal and neonatal outcomes as well as provides good postoperative pain control. Systematic review showed intrathecal morphine produced long period of pain control up to 27 hours. However, some patients still experienced moderate to severe pain which defined as postoperative pain score >,= 4. From our institute survey, there were more than 50 percents of patients undergoing cesarean delivery receiving spinal block with intrathecal morphine experienced moderate to severe pain in the first 24 hours.
The aim of the study is to determine the actual incidence and associated factors of patients whom experienced moderate to severe pain after spinal anesthesia with intrathecal morphine 200 mcg in cesarean delivery.
Read the detailed description
Spinal block with intrathecal morphine is a popular anesthetic technique in cesarean delivery. This technique brings about good maternal and neonatal outcomes as well as provides good postoperative pain control. Systematic review showed intrathecal morphine produced long period of pain control up to 27 hours. However, some patients still experienced moderate to severe pain which defined as postoperative pain score >,= 4. From our institute survey, there were more than 50 percents of patients undergoing cesarean delivery receiving spinal block with intrathecal morphine experienced moderate to severe pain in the first 24 hours. Failure in achieve adequate pain control results in poor maternal satisfaction, effect breast feeding and may lead to chronic wound pain.
The aim of the study is to determine the actual incidence of patients whom experienced moderate to severe pain after spinal anesthesia with intrathecal morphine 200 mcg in cesarean delivery. Also, factors that may involved moderate to severe postoperative pain will be analyzed and reported.
- Conditions
- Pain, Postoperative
- Keywords
- Pain, Postoperative, Cesarean delivery, Intrathecal morphine
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of moderate to severe pain
Incidence of moderate to severe pain, pain score >,= 4
Measured: The first 24 hours postoperatively
Secondary outcomes (2)
Factors associated with moderate to severe pain
Factors associated with moderate to severe pain, pain score >,= 4
Measured: The first 24 hours postoperatively
Incidence of moderate to severe pain in the 2nd postoperative day
Incidence of moderate to severe pain (pain score >,= 4) in the 2nd postoperative day
Measured: Form 24 hours to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start11 Jul 2017
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patchareya Nivatpumin, M.D., Principal investigator, Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205813
- Sponsor's protocol ID
- 164/2560(EC2)
- Status last verified
- Jan 2023
- First submitted
- 29 Jun 2017
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nivatpumin P, Pangthipampai P, Dej-Arkom S, Aroonpruksakul S, Lertbunnaphong T, Ngam-Ek-Eu T. Gestational diabetes and intraoperative tubal sterilization are risk factors for high incidence of pain after cesarean delivery: a prospective observational study. Ann Palliat Med. 2022 Apr;11(4):1170-1178. doi: 10.21037/apm-21-2139. Epub 2021 Dec 17.
PubMed 34930012
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Pain After Spinal Morphine for Cesarean Section and Analysis of Factors Involved in Moderate to Severe Pain
- ClinicalTrials.gov ID
- NCT03205813
- Acronym / sponsor ID
- 164/2560(EC2)
- Conditions
- Pain, Postoperative
- Keywords
- Pain, Postoperative, Cesarean delivery, Intrathecal morphine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 2 Jul 2017 (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.
Spinal block with intrathecal morphine is a popular anesthetic technique in cesarean delivery. This technique brings about good maternal and neonatal outcomes as well as provides good postoperative pain control. Systematic review showed intrathecal morphine produced long period of pain control up to 27 hours. However, some patients still experienced moderate to severe pain which defined as postoperative pain score >,= 4. From our institute survey, there were more than 50 percents of patients undergoing cesarean delivery receiving spinal block with intrathecal morphine experienced moderate to severe pain in the first 24 hours.
The aim of the study is to determine the actual incidence and associated factors of patients whom experienced moderate to severe pain after spinal anesthesia with intrathecal morphine 200 mcg in cesarean delivery.
Detailed description
Spinal block with intrathecal morphine is a popular anesthetic technique in cesarean delivery. This technique brings about good maternal and neonatal outcomes as well as provides good postoperative pain control. Systematic review showed intrathecal morphine produced long period of pain control up to 27 hours. However, some patients still experienced moderate to severe pain which defined as postoperative pain score >,= 4. From our institute survey, there were more than 50 percents of patients undergoing cesarean delivery receiving spinal block with intrathecal morphine experienced moderate to severe pain in the first 24 hours. Failure in achieve adequate pain control results in poor maternal satisfaction, effect breast feeding and may lead to chronic wound pain.
The aim of the study is to determine the actual incidence of patients whom experienced moderate to severe pain after spinal anesthesia with intrathecal morphine 200 mcg in cesarean delivery. Also, factors that may involved moderate to severe postoperative pain will be analyzed and reported.
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
- Patients undergoing elective cesarean delivery
Key inclusion criteria (5 listed)
- Age > 18 years
- Elective cesarean section
- Patient accept spinal anesthesia
- ASA classification I-II
- Understand numerical rating scale for pain score
Key exclusion criteria (3 listed)
- Not understand Thai
- Contraindicated in spinal anesthesia with intrathecal morphine
- Complicated pregnancy that general anesthesia may required for cesarean delivery
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
Incidence of moderate to severe pain
Time frame: The first 24 hours postoperatively
Incidence of moderate to severe pain, pain score >,= 4
2 secondary outcomes
Factors associated with moderate to severe pain
Time frame: The first 24 hours postoperatively
Incidence of moderate to severe pain in the 2nd postoperative day
Time frame: Form 24 hours to 48 hours postoperatively
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 27 Jan 2023.
- Results publication: PubMed 34930012Nivatpumin P, Pangthipampai P, Dej-Arkom S, Aroonpruksakul S, Lertbunnaphong T, Ngam-Ek-Eu T. Gestational diabetes and intraoperative tubal sterilization are risk factors for high incidence of pain after cesarean delivery: a prospective observational study. Ann Palliat Med. 2022 Apr;11(4):1170-1178. doi: 10.21037/apm-21-2139. Epub 2021 Dec 17.
- Individual participant dataSharing planned: No
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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.
Patchareya Nivatpumin, M.D. principal investigator
Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand
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 Pain, Postoperative, run by Mahidol University at 1 site in Thailand.
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 5 inclusion and 3 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 27 Jan 2023. 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 Thailand. 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?
Incidence of moderate to severe pain (time frame: The first 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03205813, which also lists 1 linked publication.
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 27 Jan 2023.