Clinical trial NCT03205813: Prospective Study of Pain After Spinal Morphine for Cesarean Section and Factors Involved in Moderate to Severe Pain
Official title: Prospective Study of Pain After Spinal Morphine for Cesarean Section and Analysis of Factors Involved in Moderate to Severe Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: Pain, Postoperative
Cesarean delivery
Intrathecal morphine
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 660
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective cesarean delivery

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.

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

Primary outcomes:
measure: Incidence of moderate to severe pain
timeFrame: The first 24 hours postoperatively
Secondary outcomes:
measure: Factors associated with moderate to severe pain
timeFrame: The first 24 hours postoperatively
measure: Incidence of moderate to severe pain in the 2nd postoperative day
timeFrame: Form 24 hours to 48 hours postoperatively
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Anesthesiology department, Siriraj hospital, Mahidol University
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand
name: Patchareya Nivatpumin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 study. Ann Palliat Med. 2022 Apr;11(4):1170-1178. doi: 10.21037/apm-21-2139. Epub 2021 Dec 17.