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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205813
• Other study ID #: 164/2560(EC2)
• Status: Completed
• Start date: July 11, 2017
• Est. completion date: January 30, 2020

Study information

• Verified date: January 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Locations

Country	Name	City	State
Thailand	Anesthesiology department, Siriraj hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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 stud — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of moderate to severe pain	Incidence of moderate to severe pain, pain score >,= 4	The first 24 hours postoperatively
Secondary	Factors associated with moderate to severe pain	Factors associated with moderate to severe pain, pain score >,= 4	The first 24 hours postoperatively
Secondary	Incidence of moderate to severe pain in the 2nd postoperative day	Incidence of moderate to severe pain (pain score >,= 4) in the 2nd postoperative day	Form 24 hours to 48 hours postoperatively