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

Completed

• Conditions: Pain, Postoperative

• Registration Number: NCT03205813
• Lead Sponsor: Mahidol University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-29
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Study Start: 2017-07-11
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 660

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of moderate to severe pain	The first 24 hours postoperatively	Incidence of moderate to severe pain, pain score \>,= 4

Secondary Outcome Measures

Name	Time	Method
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
Factors associated with moderate to severe pain	The first 24 hours postoperatively	Factors associated with moderate to severe pain, pain score \>,= 4

Trial Locations

Locations (1)

Anesthesiology department, Siriraj hospital, Mahidol University; 🇹🇭 Bangkok, Thailand