Quercetin Effect on Post-ceserean Pain

NCT ID: NCT06650891

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-30
• Study Completion Date: 2025-01-27

Brief Summary

The cesarean section is a common gynecological surgery, requiring effective pain management to prevent complications and immobility. Inadequate pain control can lead to longer hospital stays, higher readmission rates, and dissatisfaction with healthcare. Traditional analgesics, such as opioids, have proven effective in alleviating pain, but they can cause side effects. Therefore, researchers are exploring compounds that can reduce opioid analgesic needs and improve pain control. Quercetin has anti-nociceptive effects in rodent models of chronic pain, including inflammatory, neuropathic, and cancer pain. There are limited clinical studies on the effect of quercetin on acute or chronic pain. The current study is designed to assess the efficacy of preoperative quercetin administration in acute post-operative pain following cesarean section.

Detailed Description

The cesarean section is a common gynecological surgery, accounting for 40-50% of deliveries in public hospitals. Effective pain management following a cesarean delivery is crucial, as inadequate control can hinder a mother's capacity to care for her newborn. Uncontrolled postoperative pain can lead to patient immobility, increasing the risk of thromboembolic complications. Failure to adequately manage pain can result in economic and medical issues, including longer hospital stays, higher readmission rates, increased patient recovery costs, and patient dissatisfaction with the quality of healthcare provided.

Opioid medications, particularly when administered via injection, have proven effective in alleviating acute pain, but they are associated with dose-related side effects. Therefore, it is prudent to investigate compounds that can potentiate the analgesic effects of opioids, enabling improved pain control while minimizing opioid consumption. Quercetin, a flavonoid and polyphenol found in various plants and fruits, has been studied for its anti-inflammatory, free radical scavenging, antidiabetic, anticancer, cardiovascular, hepatoprotective, neuroprotective, antiplatelet, antibacterial, and anti-obesity effects. Recent evidence indicates quercetin possesses anti-nociceptive effects in rodent models of chronic pain, including inflammatory pain, neuropathic pain, and cancer pain.

Quercetin has great potential for clinical use in pain treatment, as its safety is well established. However, there are limited clinical studies on the effect of quercetin on acute or chronic pain. The current study aims to assess the efficacy of preoperative quercetin administration in acute post-operative pain following cesarean section.

Conditions

Post Operative Pain; Cesarean Section Complications

Study Design

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

Study Groups

Quercetin

receive 500mg of oral quercetin 1 hour preoperatively.

Group Type: EXPERIMENTAL

Quercetin

Intervention Type: DRUG

oral quercetin prior to surgery

Placebo

receive placebo 1 hour preoperatively

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

capsule identical looking to quercetin

Interventions

Quercetin

oral quercetin prior to surgery

Intervention Type: DRUG

Placebo

capsule identical looking to quercetin

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Referred to elective (non-emergency) cesarean section
• Undergoing spinal anesthesia) with American Society of Anesthesiologists (ASA) classification I and II
• Term gestational age

Exclusion Criteria

• History of seizures
• Pre-eclampsia or eclampsia
• Hypertension
• Use of narcotic painkillers for 24 h before the intervention
• Medications inducing neuropathy including Amiodarone, Metronidazole, Phenytoin & Colchicine.
• Prolongation of cesarean section (more than 1.5 h)
• Increase in the size of the incision
• Occurrence of any unusual complication during surgery,
• Failure of spinal anesthesia and its conversion to general anesthesia
• Contraindications to spinal anesthesia
• Use of interacting medication: fluoroquinolones, loratadine, fexofenadine, alvimopan, armodafinil

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Future University in Egypt

OTHER

Sponsor Role: lead

Responsible Party

Nouran Omar El Said

Lecturer in. Pharmacy Practice & Clinical Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

El Matarya Teaching Hospital,

Cairo, , Egypt

Countries

Egypt

References

Mohamed Elmokadem E, Khaled Abou El Fadl D, Bassiouny AM, Mahmoud MMAE, Samy M, El Said NO. The Adjunctive Effect of Quercetin on Postoperative Pain Management Following Cesarean Section: A Randomized Controlled Study. Drug Des Devel Ther. 2025 Jul 14;19:6009-6024. doi: 10.2147/DDDT.S526188. eCollection 2025.

Reference Type: DERIVED

PMID: 40687903 (View on PubMed)

Other Identifiers

RFC-PH-3/2024

Identifier Type: -

Identifier Source: org_study_id