Effectiveness of Curcuminoids in Controlling Postoperative Pain Following Total Laparoscopic Hysterectomy

Erzincan Military Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Postoperative Care; Pain Management

Treatments: Drug: liposomal curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT06886035

M07

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

126 participants in 2 patient groups

Control Group

No Intervention group

Description:

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

Study Group

Experimental group

Description:

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.

Treatment:

Drug: liposomal curcumin