Prospective Study of Pain After Spinal Morphine for Cesar... | NCT03205813

Studies
Prospective Study of Pain After Spinal Morphine for Cesarean Section and Factors Involved in Moderate to Severe Pain

NCT03205813

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Jan 27, 2023Actual

Enrollment

660Actual

Phase

Not provided

Conditions

Pain, Postoperative

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 11, 2017Actual

Primary Completion Date

Jan 30, 2020Actual

Completion Date

Jan 30, 2020Actual

First Submitted Date

Jun 29, 2017

First Submission Date that Met QC Criteria

Jun 29, 2017

First Posted Date

Jul 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2023

Last Update Posted Date

Jan 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

660Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of moderate to severe pain	Incidence of moderate to severe pain, pain score >,= 4	The first 24 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Factors associated with moderate to severe pain	Factors associated with moderate to severe pain, pain score >,= 4	The first 24 hours postoperatively
Incidence of moderate to severe pain in the 2nd postoperative day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Elective cesarean section
Patient accept spinal anesthesia
ASA classification I-II
Understand numerical rating scale for pain score

Exclusion Criteria:

Not understand Thai
Contraindicated in spinal anesthesia with intrathecal morphine
Complicated pregnancy that general anesthesia may required for cesarean delivery

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing elective cesarean delivery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patchareya Nivatpumin, M.D.	Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anesthesiology department, Siriraj hospital, Mahidol University		Bangkok		10700	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34930012	Result	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.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain