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NCT Number: NCT03205813

Prospective Study of Pain After Spinal Morphine for Cesarean Section and 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Anesthesiology department, Siriraj hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of moderate to severe pain

    Time frame: The first 24 hours postoperatively

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

Secondary outcomes

  1. Factors associated with moderate to severe pain

    Time frame: 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

    Time frame: Form 24 hours to 48 hours postoperatively

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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2017
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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