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

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT03205813
Collaborator
(none)
660
1
30.7
21.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    660 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Study of Pain After Spinal Morphine for Cesarean Section and Analysis of Factors Involved in Moderate to Severe Pain
    Actual Study Start Date :
    Jul 11, 2017
    Actual Primary Completion Date :
    Jan 30, 2020
    Actual Study Completion Date :
    Jan 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of moderate to severe pain [The first 24 hours postoperatively]

      Incidence of moderate to severe pain, pain score >,= 4

    Secondary Outcome Measures

    1. Factors associated with moderate to severe pain [The first 24 hours postoperatively]

      Factors associated with moderate to severe pain, pain score >,= 4

    2. Incidence of moderate to severe pain in the 2nd postoperative day [Form 24 hours to 48 hours postoperatively]

      Incidence of moderate to severe pain (pain score >,= 4) in the 2nd postoperative day

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anesthesiology department, Siriraj hospital, Mahidol University Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Patchareya Nivatpumin, M.D., Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mahidol University
    ClinicalTrials.gov Identifier:
    NCT03205813
    Other Study ID Numbers:
    • 164/2560(EC2)
    First Posted:
    Jul 2, 2017
    Last Update Posted:
    Apr 8, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mahidol University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 8, 2020