Quercetin Effect on Post-ceserean Pain

The Adjunctive Effect of Quercetin on Postoperative Pain Management Following Cesarean Section

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Post Operative Pain
• Intervention / Treatment: Drug: Quercetin; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • El Matarya Teaching Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quercetin; receive 500mg of oral quercetin 1 hour preoperatively.	Drug: Quercetin; oral quercetin prior to surgery
Placebo Comparator: Placebo; receive placebo 1 hour preoperatively	Other: Placebo; capsule identical looking to quercetin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity (2 hours)	Pain intensity using 10 cm Visual analog scale (VAS) scale	2 hours
Pain intensity (6 hours)	Pain intensity using 10 cm Visual analog scale (VAS) scale	6 hours
Pain intensity (12 hours)	Pain intensity using 10 cm Visual analog scale (VAS) scale	12 hours
Pain intensity (24 hours)	Pain intensity using 10 cm Visual analog scale (VAS) scale	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea & vomiting (2 hours)	severity of nausea/vomiting (n/v) using a numerical scale from 0 to 2 (0 = no nausea, 1 = mild n/v, and 2 = severe n/v)	2 hours
Nausea & vomiting (6 hours)	severity of nausea/vomiting (n/v) using a numerical scale from 0 to 2 (0 = no nausea, 1 = mild n/v, and 2 = severe n/v)	6 hours
Nausea & vomiting (12 hours)	severity of nausea/vomiting (n/v) using a numerical scale from 0 to 2 (0 = no nausea, 1 = mild n/v, and 2 = severe n/v)	12 hours
Nausea & vomiting (24 hours)	severity of nausea/vomiting (n/v) using a numerical scale from 0 to 2 (0 = no nausea, 1 = mild n/v, and 2 = severe n/v)	24 hours
Rescue analgesia	The patient's first request for postoperative analgesia	24 hours
Opioid intake	The patient's opioid intake in the 24-h after surgery	24 hours

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Actual): January 27, 2025
• Study Completion (Actual): January 27, 2025

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Cesarean section; quercetin; opioid use; post-operative pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antioxidants; Protective Agents; Quercetin
• Other Study ID Numbers: RFC-PH-3/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No