Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 vs 0.2 mg in Cesarean Section

June 27, 2025 updated by: Thepakorn Sathitkarnmanee, Khon Kaen University

Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 and 0.2 Milligrams in Cesarean Section: A Randomized Clinical Trial

This study compares the incidence of pruritus (itching) requiring treatment between two doses of intrathecal morphine (0.1 mg vs 0.2 mg) when used for spinal anesthesia during cesarean section. The study aims to determine if the lower dose (0.1 mg) can reduce pruritus incidence while maintaining adequate pain relief.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Spinal anesthesia is a standard technique for cesarean section. Intrathecal morphine (ITM) provides prolonged and effective analgesia but may cause adverse events including pruritus, nausea, vomiting, and respiratory depression. Current practice at Srinagarind Hospital uses ITM 0.2 mg for spinal anesthesia in cesarean section. This study investigates whether reducing the ITM dose to 0.1 mg can decrease pruritus incidence while preserving analgesic effectiveness.

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Faculty Of Medicine, Khon Kaen University
        • Contact:
        • Principal Investigator:
          • Sirirat Tribuddharat, MD, PhD
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Thepakorn Sathitkarnmanee
        • Contact:
        • Principal Investigator:
          • Thepakorn Sathitkarnmanee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: • Pregnant women aged 18-45 years

  • Full-term pregnancy
  • Scheduled for non-emergency cesarean section
  • ASA physical status I-III
  • Non-complicated pregnancy

Exclusion Criteria:

  • Contraindication to spinal anesthesia or study drugs
  • Refusal to participate in the study
  • BMI ≥ 40 kg/m²
  • History of systemic skin disease or current itchy skin condition
  • Use of antihistamines or anti-pruritic medications within 3 days prior to surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ITM 0.1 mg
Participants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.1 mg intrathecally
Drug: Morphine Sulfate
intrathecal administered morphine
Active Comparator: ITM 0.2 mg
Participants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.2 mg intrathecally
Drug: Morphine Sulfate
intrathecal administered morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of pruritus requiring treatment [Time Frame: 24 hours post-operatively]
Time Frame: 24 hours
  • Percentage of participants requiring treatment for pruritus within 24 hours after spinal anesthesia
  • Measured using numerical rating scale (0-10), with treatment indicated for score ≥4
  • Percentage of participants requiring treatment for pruritus within 24 hours after spinal anesthesia
  • Measured using numerical rating scale (0-10), with treatment indicated for score ≥4
  • Percentage of participants requiring treatment for pruritus within 24 hours after spinal anesthesia
  • Measured using numerical rating scale (0-10), with treatment indicated for score ≥4
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Study Chair: Thepakorn Sathitkarnmanee, Faculty Of Medicine, Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

June 27, 2025

First Submitted That Met QC Criteria

June 27, 2025

First Posted (Estimated)

July 8, 2025

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE631484

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pruritus Caused by Drug

Clinical Trials on Morphine Sulfate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe