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

NCT ID: NCT07054775

Last Updated: 2025-07-08

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

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pruritus Caused by Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arm 1: intrathecal morphine (ITM) 0.1 mg Arm 2" intrathecal morphine (ITM) 0.2 mg
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
They are unaware of type of drug administered.

Study Groups

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ITM 0.1 mg

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

Group Type ACTIVE_COMPARATOR

Morphine Sulfate

Intervention Type DRUG

intrathecal administered morphine

ITM 0.2 mg

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

Group Type ACTIVE_COMPARATOR

Morphine Sulfate

Intervention Type DRUG

intrathecal administered morphine

Interventions

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Morphine Sulfate

intrathecal administered morphine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Thepakorn Sathitkarnmanee

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thepakorn Sathitkarnmanee

Role: STUDY_CHAIR

Faculty of Medicine, Khon Kaen University

Locations

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Faculty of Medicine, Khon Kaen University

Khon Kaen, , Thailand

Site Status RECRUITING

Thepakorn Sathitkarnmanee

Khon Kaen, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Thepakorn Sathitkarnbmanee

Role: CONTACT

66-81-9547622

Sirirat Tribuddharat

Role: CONTACT

66-81-6205920

Facility Contacts

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Thepakorn Sathitkarnmanee, MD

Role: primary

+66819547622

Thepakorn Sathitkarnmanee, MD

Role: primary

66-81-9547622

References

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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.

Reference Type RESULT
PMID: 24106351 (View on PubMed)

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.

Reference Type RESULT
PMID: 15983470 (View on PubMed)

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.

Reference Type RESULT
PMID: 27089000 (View on PubMed)

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.

Reference Type RESULT
PMID: 19462494 (View on PubMed)

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.

Reference Type RESULT
PMID: 9952150 (View on PubMed)

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.

Reference Type RESULT
PMID: 28464238 (View on PubMed)

Other Identifiers

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HE631484

Identifier Type: -

Identifier Source: org_study_id

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