Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-12

Study Completion Date

2022-12-31

Brief Summary

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To evaluate that perioperative regular usage of propacetamol to reduce post cesarean section uterine contraction pain and opioid consumption

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Detailed Description

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The most common method of pain control after cesarean section is intravenous patient-control analgesia (IVPCA) with morphine. Multimodal analgesia could improve the quality of perioperative pain control and reduceside effects of opioids. Previous researches marked that perioperative pain after cesarean section includes somatic wound pain and visceral uterine contraction pain.

According to Academy of Breastfeeding Medicine, propacetamol is a safe pain-killer for an expectant mother and almost free from breast milk after intravenous injection. This study is a prospective double-blind randomized-controlled trial to evaluate that propacetamol could reduce visceral uterine contraction pain after cesarean section. Post cesarean section women will divide into three groups:

1. pain control with IVPCA for 2 days
2. pain control with IVPCA and propacetamol 1g every 6 hours for 2 days
3. pain control with IVPCA and propacetamol 2g every 6 hours for 2 days

Conditions

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Uterine Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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propacetamol 1g

pain control with IVPCA and propacetamol 1g every 6 hours for 2 days

Group Type ACTIVE_COMPARATOR

Propacetamol 1g

Intervention Type DRUG

pain control with IVPCA and propacetamol 1g every 6 hours for 2 days

IVPCA

Intervention Type DRUG

pain control with IVPCA

propacetamol 2g

pain control with IVPCA and propacetamol 2g every 6 hours for 2 days

Group Type ACTIVE_COMPARATOR

Propacetamol 2g

Intervention Type DRUG

pain control with IVPCA and propacetamol 2g every 6 hours for 2 days

IVPCA

Intervention Type DRUG

pain control with IVPCA

IVPCA

pain control with IVPCA

Group Type PLACEBO_COMPARATOR

IVPCA

Intervention Type DRUG

pain control with IVPCA

Interventions

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Propacetamol 1g

pain control with IVPCA and propacetamol 1g every 6 hours for 2 days

Intervention Type DRUG

Propacetamol 2g

pain control with IVPCA and propacetamol 2g every 6 hours for 2 days

Intervention Type DRUG

IVPCA

pain control with IVPCA

Intervention Type DRUG

Other Intervention Names

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Propacetamol 1g + IVPCA Propacetamol 2g + IVPCA IVPCA alone

Eligibility Criteria

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Inclusion Criteria

* Pregnancy more than 36 weeks which is expected to receive Caesarean section
* Post Caesarean section woman, age greater than or equal to 20 years old
* ASA physical status class 1 or 2

Exclusion Criteria

* ASA physical status class 3 or above
* Less than 20 years old
* Past caesarean section for longitudinal wounds
* Undergone major abdominal surgery
* Chronic pain
* Allergic to morphine or Propacetamol
* Liver dysfunction
* Treatment with anticoagulant
* Emergency operation

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes