Clinical trial NCT06886035: Effectiveness of Curcuminoids in Controlling Postoperative Pain Following Total Laparoscopic Hysterectomy
Official title: Effectiveness of Curcuminoids in Controlling Postoperative Pain Following Total Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Postoperative Care
Pain Management
Lead sponsor: Erzincan Military Hospital
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 126
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: the visual analogue scale (VAS)
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.