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

NCT07054775 | Recruiting Phase 4

• 1 other identifier: HE631484
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pruritus Caused by Drug

Outcome Measures

Primary Outcomes (1)

• Incidence of pruritus requiring treatment [Time Frame: 24 hours post-operatively]

  * 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

Study Arms (2)

ITM 0.1 mg

ACTIVE COMPARATOR

Participants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.1 mg intrathecally

Drug: Morphine Sulfate

ITM 0.2 mg

ACTIVE COMPARATOR

Participants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.2 mg intrathecally

Drug: Morphine Sulfate

Interventions

Morphine Sulfate DRUG

intrathecal administered morphine

ITM 0.1 mg; ITM 0.2 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant female undergoing cesarean section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (2)

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

RECRUITING

Thepakorn Sathitkarnmanee

Khon Kaen, 40002, Thailand

RECRUITING

Related Publications (6)

• Kumar K, Singh SI. Neuraxial opioid-induced pruritus: An update. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):303-7. doi: 10.4103/0970-9185.117045.

  PMID: 24106351 RESULT

• Waxler B, Dadabhoy ZP, Stojiljkovic L, Rabito SF. Primer of postoperative pruritus for anesthesiologists. Anesthesiology. 2005 Jul;103(1):168-78. doi: 10.1097/00000542-200507000-00025.

  PMID: 15983470 RESULT

• Sultan P, Halpern SH, Pushpanathan E, Patel S, Carvalho B. The Effect of Intrathecal Morphine Dose on Outcomes After Elective Cesarean Delivery: A Meta-Analysis. Anesth Analg. 2016 Jul;123(1):154-64. doi: 10.1213/ANE.0000000000001255.

  PMID: 27089000 RESULT

• Gehling M, Tryba M. Risks and side-effects of intrathecal morphine combined with spinal anaesthesia: a meta-analysis. Anaesthesia. 2009 Jun;64(6):643-51. doi: 10.1111/j.1365-2044.2008.05817.x.

  PMID: 19462494 RESULT

• Palmer CM, Emerson S, Volgoropolous D, Alves D. Dose-response relationship of intrathecal morphine for postcesarean analgesia. Anesthesiology. 1999 Feb;90(2):437-44. doi: 10.1097/00000542-199902000-00018.

  PMID: 9952150 RESULT

• Wang W, Zhou L, Sun L. Ondansetron for neuraxial morphine-induced pruritus: A meta-analysis of randomized controlled trials. J Clin Pharm Ther. 2017 Aug;42(4):383-393. doi: 10.1111/jcpt.12539. Epub 2017 May 2.

  PMID: 28464238 RESULT

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Thepakorn Sathitkarnmanee

  Faculty of Medicine, Khon Kaen University

  STUDY CHAIR

Central Study Contacts

Thepakorn Sathitkarnbmanee

CONTACT

66-81-9547622; thepakorns@gmail.com

Sirirat Tribuddharat

CONTACT

66-81-6205920; sirirat.tribuddharat@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: They are unaware of type of drug administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Arm 1: intrathecal morphine (ITM) 0.1 mg Arm 2" intrathecal morphine (ITM) 0.2 mg

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: June 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: November 30, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)