Postoperative PainNCT07368790
Elective Total Abdominal Hysterectomy With Preoperative Analgesia Intravenous Paracetamol Versus Placebo
A study testing Paracetamol in people with Postoperative Pain, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial summary
The study aim to study to evaluate whether IV paracetamol reduces morphine use after TAH. Primary objective was to compare postoperative morphine consumption between the IV paracetamol and control groups. and Secondary objective was to compare postoperative pain scores using the Numeric Rating Scale OR NRS Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Paracetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 10 Oct 2024to 20 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 30-50 years.
- Scheduled to undergo total abdominal hysterectomy (TAH) at Queen Savang Vadhana Memorial Hospital at Sriracha
- No history of allergy to paracetamol (acetaminophen) or morphine.
- Normal renal function: serum creatinine ≤ 1.2 mg/dL.
- No severe or recurrent liver disease, and AST or ALT ≤ 3× the upper limit of normal.
- Able to communicate in Thai, complete the questionnaire, and provide written informed consent (no restriction on race or nationality).
Who cannot join
- Incomplete medical record.
- Use of any analgesic medications within 24 hours preoperatively.
- Receipt of any postoperative analgesic other than morphine during the first 24 hours after surgery.
- Withdrawal from the study.
- Adverse reaction after administration of the study drug.
- Concomitant surgery involving other organs (e.g., ovary or lymph nodes).
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Queen Savang Vadhana Memorial Hospital, Thai Red Cross Society, Jermjomphon street, Chonburi, 20110,
Chon Buri
About this study
Official title: A Comparison of Postoperative Morphine Consumption in Patients Undergoing Elective Total Abdominal Hysterectomy With Preoperative Analgesia Intravenous Paracetamol Versus Placebo
The study aim to study to evaluate whether IV paracetamol reduces morphine use after TAH. Primary objective was to compare postoperative morphine consumption between the IV paracetamol and control groups.
and Secondary objective was to compare postoperative pain scores using the Numeric Rating Scale OR NRS
Read the detailed description
We conducted a randomized, double-blind, placebo-controlled trial at our hospital (QSMH) , including women undergoing elective TAH The trial was conducted between October 2024 (two thousand twenty-four) and May 2025 (two thousand twenty-five) , with approval from the institutional review board.
Participants were randomized 1:1 (one to one) to receive IV paracetamol 1 g or IV normal saline, administered in the operating room before induction of anesthesia, Postoperatively, pain was assessed intermittently using the NRS (์numeric rating scale) at 1, 6, 12, and 24 hours, with morphine 0.1 mg/kg (zero point one milligrams per kilogram) Intravenous provided on demand.
The primary outcome was the number of morphine injections within 24 hours; the secondary outcome was NRS pain scores.
- Conditions
- Postoperative Pain
- Being tested
- Paracetamol, Placebo
- Keywords
- Paracetamol, Morphine, Total abdominal hysterectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Patients receive IV paracetamol 1 gm Postoperatively morphine 0.1 mg/kg was given intravenous provided on demand at at 1, 6, 12, and 24 hours.
PlaceboDrug
Pateint recieved IV normal saline Postoperatively, pain was assessed intermittently using the NRS (์numeric rating scale) at 1, 6, 12, and 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Experimental | Patients which recieved intravenous paracetamol preoperatively Receives: Drug: Paracetamol |
| Placebo | Placebo comparator | Patients which recieved placebo preoperatively Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare postoperative morphine consumption between the IV paracetamol and control groups.
Measured: at 1, 6, 12, and 24 hours postoperation
Secondary outcomes (1)
Compare postoperative pain scores using the Numeric Rating Scale OR NRS
Measured: at 1, 6, 12, and 24 hours postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start10 Oct 2024
- Primary completion20 May 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panumat Phungtippimanchai, Principal investigator, Queen Savang Vadhana Memorial Hospital, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368790
- Sponsor's protocol ID
- 011/2567
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data was save in form of microsoft excel spreadsheet and SPSS file
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Postoperative Morphine Consumption in Patients Undergoing Elective Total Abdominal Hysterectomy With Preoperative Analgesia Intravenous Paracetamol Versus Placebo
- ClinicalTrials.gov ID
- NCT07368790
- Acronym / sponsor ID
- 011/2567
- Conditions
- Postoperative Pain
- Keywords
- Paracetamol, Morphine, Total abdominal hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 27 Jan 2026 (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.
The study aim to study to evaluate whether IV paracetamol reduces morphine use after TAH. Primary objective was to compare postoperative morphine consumption between the IV paracetamol and control groups.
and Secondary objective was to compare postoperative pain scores using the Numeric Rating Scale OR NRS
Detailed description
We conducted a randomized, double-blind, placebo-controlled trial at our hospital (QSMH) , including women undergoing elective TAH The trial was conducted between October 2024 (two thousand twenty-four) and May 2025 (two thousand twenty-five) , with approval from the institutional review board.
Participants were randomized 1:1 (one to one) to receive IV paracetamol 1 g or IV normal saline, administered in the operating room before induction of anesthesia, Postoperatively, pain was assessed intermittently using the NRS (์numeric rating scale) at 1, 6, 12, and 24 hours, with morphine 0.1 mg/kg (zero point one milligrams per kilogram) Intravenous provided on demand.
The primary outcome was the number of morphine injections within 24 hours; the secondary outcome was NRS pain scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Experimental | Drug: ParacetamolPatients which recieved intravenous paracetamol preoperatively |
| Placebo | Placebo comparator | Drug: PlaceboPatients which recieved placebo preoperatively |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female patients aged 30-50 years.
- Scheduled to undergo total abdominal hysterectomy (TAH) at Queen Savang Vadhana Memorial Hospital at Sriracha
- No history of allergy to paracetamol (acetaminophen) or morphine.
- Normal renal function: serum creatinine ≤ 1.2 mg/dL.
- No severe or recurrent liver disease, and AST or ALT ≤ 3× the upper limit of normal.
Key exclusion criteria (6 listed)
- Incomplete medical record.
- Use of any analgesic medications within 24 hours preoperatively.
- Receipt of any postoperative analgesic other than morphine during the first 24 hours after surgery.
- Withdrawal from the study.
- Adverse reaction after administration of the study drug.
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 |
|---|---|---|
| ParacetamolPatients receive IV paracetamol 1 gm Postoperatively morphine 0.1 mg/kg was given intravenous provided on demand at at 1, 6, 12, and 24 hours. | Drug | Paracetamol |
| PlaceboPateint recieved IV normal saline Postoperatively, pain was assessed intermittently using the NRS (์numeric rating scale) at 1, 6, 12, and 24 hours | Drug | Placebo |
Primary outcome
Compare postoperative morphine consumption between the IV paracetamol and control groups.
Time frame: at 1, 6, 12, and 24 hours postoperation
1 secondary outcome
Compare postoperative pain scores using the Numeric Rating Scale OR NRS
Time frame: at 1, 6, 12, and 24 hours postoperation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Undecided. data was save in form of microsoft excel spreadsheet and SPSS file
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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. This study is not recruiting at the moment.
Panumat Phungtippimanchai principal investigator
Queen Savang Vadhana Memorial Hospital, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol in people with Postoperative Pain, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare postoperative morphine consumption between the IV paracetamol and control groups. (time frame: at 1, 6, 12, and 24 hours postoperation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2026.