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Clinical Trials/NCT03205813
NCT03205813
Completed
Not Applicable

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

Mahidol University1 site in 1 country660 target enrollmentJuly 11, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Mahidol University
Enrollment
660
Locations
1
Primary Endpoint
Incidence of moderate to severe pain
Status
Completed
Last Updated
3 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
July 11, 2017
End Date
January 30, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Incidence of moderate to severe pain

Time Frame: The first 24 hours postoperatively

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

Secondary Outcomes

  • Incidence of moderate to severe pain in the 2nd postoperative day(Form 24 hours to 48 hours postoperatively)
  • Factors associated with moderate to severe pain(The first 24 hours postoperatively)

Study Sites (1)

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