Postoperative CarePhase 4NCT06886035
Effectiveness of Curcuminoids in Controlling Postoperative Pain Following Total Laparoscopic Hysterectomy
A Phase 4 study testing liposomal curcumin in people with Postoperative Care and Pain Management, run by Erzincan Military Hospital at 1 site in Turkey (Türkiye).
Trial summary
Total hysterectomy is one of the most common surgical procedures in gynecology. Total laparoscopic hysterectomy (TLH) has several advantages over open surgery, such as better cosmetic outcomes, faster recovery, and an earlier return to normal activities and work, and has thus become the preferred approach Nonetheless… Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Care, Pain Management
- What is being tested?
- liposomal curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2025to 31 Jan 2026
- Phase
- Phase 4
- 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 20 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Laparoscopic total hysterectomy and salpingectomy, with the option of additional procedures such as oophorectomy, uterosacral ligament plications, trans obturator tape insertion, or sentinel lymphadenectomy candidates
- They should be able to understand and sign an informed consent
- They should be literate enough to understand the maintenance of a diary recording pain scores, QoL-15 scores, and any adverse event
Who cannot join
- Patients with any peripheral or central neuropathic pain
- Patients used to taking over-the-counter painkiller pills
- Patients with a history of alcohol intake/drug dependence
- Patients with a history of psychosis
- Patients with chronic inflammatory diseases who cannot be taken off nonsteroidal anti-inflammatory drugs (NSAIDs)/painkillers
- Patients on immunosuppressive/cytotoxic/steroid therapy.
Show all 11Show fewer
- American Society of Anesthesiologists physical status classification of ≥ IV
- known hypersensitivity to curcumin; current opioid use for any indication;
- concurrent procedures for deep infiltrating endometriosis, sacrocolpopexy,
- concomitant intestinal surgery
- refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Total hysterectomy is one of the most common surgical procedures in gynecology. Total laparoscopic hysterectomy (TLH) has several advantages over open surgery, such as better cosmetic outcomes, faster recovery, and an earlier return to normal activities and work, and has thus become the preferred approach Nonetheless, postoperative pain (PP) remains an issue of concern.
The reported incidence of PP after TLH ranges from 35 % to 63 %. The origin of PP after laparoscopy is multifactorial, arising from several perioperative factors, including pneumoperitoneum, stretching of the intraabdominal cavity, blood left in the abdomen, and dissection of the pelvic region. A prospective trial found more intense pain and greater analgesia requirement in the immediate postoperative period associated with laparoscopic surgery than with laparotomy. Methods to decrease the severity of PP are required before TLH can be confidently recommended.
Read more
Curcumin has several benefits, which are endorsed by the World Health Organization (WHO).
That is, it can be used to treat dyspepsia and peptic ulcer. Moreover, it has anti-inflammatory and analgesic properties. Most benefits are attributed to its anti-oxidant and anti-inflammatory effects. Curcuminoid is the active ingredient of turmeric. Curcuminoids are used in laparoscopic surgery because of their aforementioned benefits. Further, the use of traditional medicine, which is low-cost and effective in improving postoperative pain due to abdominal diştention, is assessed.
- Conditions
- Postoperative Care, Pain Management
- Being tested
- liposomal curcumin
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal curcuminDrug
The study group began a regimen of 100 mg oral liposomal curcumin (administered as 50 mg twice daily) one day prior to the procedure. Following surgery, oral liposomal curcumin (50 mg twice daily) was restarted 8 hours postoperatively and maintained for an additional two days. ( A total dose 300 mg)
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Our clinical ERAS (Enhanced Recovery After Surgery) protocols were implemented to control patients without any additional intervention (Placebo drug: Identical-appearing placebo capsules were administered at the same time points and dosing schedules.) Receives: Drug: liposomal curcumin |
| Study Group | Experimental | Our clinical ERAS (Enhanced Recovery After Surgery) protocols were implemented to study patients. The study group also began a regimen of 100 mg oral liposomal curcumin (administered as 50 mg twice daily) one day before the procedure. Following surgery, oral liposomal curcumin (50 mg twice daily) was restarted 8 hours postoperatively and maintained for an additional two days. Receives: Drug: liposomal curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the visual analogue scale (VAS)
The primary goal was to assess the variation in postoperative pain levels recorded on the VAS (scored from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable) 24 hours after surgery
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start21 Mar 2025
- Primary completion31 Dec 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative CareStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemal GUNGORDUK, Erzincan Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886035
- Sponsor's protocol ID
- M07
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ariyasriwatana C, Phoolcharoen N, Oranratanaphan S, Worasethsin P. Efficacy of Curcuminoids in Managing Postoperative Pain after Total Laparoscopic Hysterectomy: A Randomized Controlled, Open-Label Trial. Complement Med Res. 2022;29(3):223-227. doi: 10.1159/000521669. Epub 2022 Jan 5.
PubMed 34986477Nurullahoglu KE, Okudan N, Belviranli M, Oz M. The comparison of preemptive analgesic effects of curcumin and diclofenac. Bratisl Lek Listy. 2014;115(12):757-60. doi: 10.4149/bll_2014_146.
PubMed 25520223
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Curcuminoids in Controlling Postoperative Pain Following Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT06886035
- Acronym / sponsor ID
- M07
- Conditions
- Postoperative Care, Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Erzincan Military HospitalUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 20 Mar 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.
Total hysterectomy is one of the most common surgical procedures in gynecology. Total laparoscopic hysterectomy (TLH) has several advantages over open surgery, such as better cosmetic outcomes, faster recovery, and an earlier return to normal activities and work, and has thus become the preferred approach Nonetheless, postoperative pain (PP) remains an issue of concern.
The reported incidence of PP after TLH ranges from 35 % to 63 %. The origin of PP after laparoscopy is multifactorial, arising from several perioperative factors, including pneumoperitoneum, stretching of the intraabdominal cavity, blood left in the abdomen, and dissection of the pelvic region. A prospective trial found more intense pain and greater analgesia requirement in the immediate postoperative period associated with laparoscopic surgery than with laparotomy. Methods to decrease the severity of PP are required before TLH can be confidently recommended.
Curcumin has several benefits, which are endorsed by the World Health Organization (WHO).
That is, it can be used to treat dyspepsia and peptic ulcer. Moreover, it has anti-inflammatory and analgesic properties. Most benefits are attributed to its anti-oxidant and anti-inflammatory effects. Curcuminoid is the active ingredient of turmeric. Curcuminoids are used in laparoscopic surgery because of their aforementioned benefits. Further, the use of traditional medicine, which is low-cost and effective in improving postoperative pain due to abdominal diştention, is assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: liposomal curcuminOur clinical ERAS (Enhanced Recovery After Surgery) protocols were implemented to control patients without any additional intervention (Placebo drug: Identical-appearing placebo capsules were administered at the same time points and dosing schedules.) |
| Study Group | Experimental | Drug: liposomal curcuminOur clinical ERAS (Enhanced Recovery After Surgery) protocols were implemented to study patients. The study group also began a regimen of 100 mg oral liposomal curcumin (administered as 50 mg twice daily) one day before the procedure. Following surgery, oral liposomal curcumin (50 mg twice daily) was restarted 8 hours postoperatively and maintained for an additional two days. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- -Laparoscopic total hysterectomy and salpingectomy, with the option of additional procedures such as oophorectomy, uterosacral ligament plications, trans obturator tape insertion, or sentinel lymphadenectomy candidates
- They should be able to understand and sign an informed consent
- They should be literate enough to understand the maintenance of a diary recording pain scores, QoL-15 scores, and any adverse event
Key exclusion criteria (11 listed)
- Patients with any peripheral or central neuropathic pain
- Patients with chronic inflammatory diseases who cannot be taken off nonsteroidal anti-inflammatory drugs (NSAIDs)/painkillers
- American Society of Anesthesiologists physical status classification of ≥ IV
- known hypersensitivity to curcumin; current opioid use for any indication;
- concurrent procedures for deep infiltrating endometriosis, sacrocolpopexy,
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 |
|---|---|---|
| liposomal curcuminThe study group began a regimen of 100 mg oral liposomal curcumin (administered as 50 mg twice daily) one day prior to the procedure. Following surgery, oral liposomal curcumin (50 mg twice daily) was restarted 8 hours postoperatively and maintained for an additional two days. ( A total dose 300 mg) | Drug | Control Group, Study Group |
Primary outcome
the visual analogue scale (VAS)
Time frame: 24 hours after surgery
The primary goal was to assess the variation in postoperative pain levels recorded on the VAS (scored from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable) 24 hours after surgery
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 2 Apr 2026.
- Results publication: PubMed 34986477Ariyasriwatana C, Phoolcharoen N, Oranratanaphan S, Worasethsin P. Efficacy of Curcuminoids in Managing Postoperative Pain after Total Laparoscopic Hysterectomy: A Randomized Controlled, Open-Label Trial. Complement Med Res. 2022;29(3):223-227. doi: 10.1159/000521669. Epub 2022 Jan 5.
- Results publication: PubMed 25520223Nurullahoglu KE, Okudan N, Belviranli M, Oz M. The comparison of preemptive analgesic effects of curcumin and diclofenac. Bratisl Lek Listy. 2014;115(12):757-60. doi: 10.4149/bll_2014_146.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Care
Not yet recruitingPhase 4
Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery
Heart Failure, Cardiac Surgery
Active, not recruiting
VentilO Prospective Study
Mechanical Ventilation Complication, Respiratory Acidosis
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
RecruitingObservational study
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
Preoperative Care, Surgery--Complications
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing liposomal curcumin in people with Postoperative Care and Pain Management, run by Erzincan Military Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 11 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 2 Apr 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 Turkey (Türkiye). 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.
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?
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?
the visual analogue scale (VAS) (time frame: 24 hours after surgery). 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 NCT06886035, which also lists 2 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 2 Apr 2026.