Effectiveness of Curcuminoids in Controlling Postoperative Pain Following Total Laparoscopic Hysterectomy

NCT ID: NCT06886035

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-21
• Study Completion Date: 2026-01-15

Brief 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, 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.

Conditions

Postoperative Care; Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control Group

Our clinical ERAS (Enhanced Recovery After Surgery) protocols were implemented to control patients without any additional intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Study Group

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.

Group Type: EXPERIMENTAL

liposomal curcumin

Intervention Type: DRUG

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)

Interventions

liposomal curcumin

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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-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

Exclusion Criteria

• 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. *Patients with a known allergy to duloxetine

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Erzincan Military Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kemal GUNGORDUK

prof dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Kemal Güngördük, MD, PROF.

Role: CONTACT

drkemalgungorduk@gmail.com

+905054921766

References

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.

Reference Type: BACKGROUND

PMID: 34986477 (View on PubMed)

Nurullahoglu 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.

Reference Type: BACKGROUND

PMID: 25520223 (View on PubMed)

Other Identifiers

M07

Identifier Type: -

Identifier Source: org_study_id