Pruritus Caused by DrugPhase 4NCT07054775
Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 vs 0.2 mg in Cesarean Section
A Phase 4 study testing Morphine Sulfate in people with Pruritus Caused by Drug, run by Khon Kaen University at 2 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pruritus Caused by Drug
- What is being tested?
- Morphine Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Jun 2025to 30 Nov 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full-term pregnancy
- Scheduled for non-emergency cesarean section
- ASA physical status I-III
- Non-complicated pregnancy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand2 sites, 2 recruiting
- Recruiting
Faculty of Medicine, Khon Kaen University
Khon Kaen, 40002
Thepakorn Sathitkarnmanee, MD, +66819547622, thepakorns@gmail.com
Sirirat Tribuddharat, MD, PhD
- Recruiting
Thepakorn Sathitkarnmanee
Khon Kaen, 40002
Thepakorn Sathitkarnmanee, MD, 66-81-9547622, thepakorns@gmail.com
Thepakorn Sathitkarnmanee, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Pruritus Caused by Drug
- Being tested
- Morphine Sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine SulfateDrug
intrathecal administered morphine
| Study group | Role | What they receive |
|---|---|---|
| ITM 0.1 mg | Active comparator | Participants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.1 mg intrathecally Receives: Drug: Morphine Sulfate |
| ITM 0.2 mg | Active comparator | Participants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.2 mg intrathecally Receives: Drug: Morphine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Jun 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pruritus Caused by DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: intrathecal morphine (ITM) 0.1 mg Arm 2" intrathecal morphine (ITM) 0.2 mg
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thepakorn Sathitkarnmanee, Khon Kaen University
- Investigators
- Thepakorn Sathitkarnmanee, Study chair, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054775
- Sponsor's protocol ID
- HE631484
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24106351Waxler 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.
PubMed 15983470Sultan 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.
PubMed 27089000Gehling 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.
PubMed 19462494Palmer 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.
PubMed 9952150Wang 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.
PubMed 28464238
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 and 0.2 Milligrams in Cesarean Section: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07054775
- Acronym / sponsor ID
- HE631484
- Conditions
- Pruritus Caused by Drug
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Arm 1: intrathecal morphine (ITM) 0.1 mg Arm 2" intrathecal morphine (ITM) 0.2 mg
| Arm | Type | Receives |
|---|---|---|
| ITM 0.1 mg | Active comparator | Drug: Morphine SulfateParticipants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.1 mg intrathecally |
| ITM 0.2 mg | Active comparator | Drug: Morphine SulfateParticipants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.2 mg intrathecally |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Full-term pregnancy
- Scheduled for non-emergency cesarean section
- ASA physical status I-III
- Non-complicated pregnancy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine Sulfateintrathecal administered morphine | Drug | ITM 0.1 mg, ITM 0.2 mg |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Results publication: PubMed 24106351Kumar 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.
- Results publication: PubMed 15983470Waxler 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.
- Results publication: PubMed 27089000Sultan 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.
- Results publication: PubMed 19462494Gehling 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.
- Results publication: PubMed 9952150Palmer 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.
- Results publication: PubMed 28464238Wang 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.
- Individual participant dataSharing planned: No
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Pruritus Caused by Drug
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thepakorn Sathitkarnmanee study chair
Khon Kaen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine Sulfate in people with Pruritus Caused by Drug, run by Khon Kaen University at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thepakorn Sathitkarnbmanee (66-81-9547622, thepakorns@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pruritus requiring treatment [Time Frame: 24 hours post-operatively] (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07054775, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.