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Completed

NCT Number: NCT06650891

Quercetin Effect on Post-ceserean Pain

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

El Matarya Teaching Hospital,

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quercetin

Drug

oral quercetin prior to surgery

Placebo

Other

capsule identical looking to quercetin

Primary outcomes

  1. Pain intensity (2 hours)

    Time frame: 2 hours

    Pain intensity using 10 cm Visual analog scale (VAS) scale

  2. Pain intensity (6 hours)

    Time frame: 6 hours

    Pain intensity using 10 cm Visual analog scale (VAS) scale

  3. Pain intensity (12 hours)

    Time frame: 12 hours

    Pain intensity using 10 cm Visual analog scale (VAS) scale

  4. Pain intensity (24 hours)

    Time frame: 24 hours

    Pain intensity using 10 cm Visual analog scale (VAS) scale

Secondary outcomes

  1. Nausea & vomiting (2 hours)

    Time frame: 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. Nausea & vomiting (6 hours)

    Time frame: 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)

  3. Nausea & vomiting (12 hours)

    Time frame: 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)

  4. Nausea & vomiting (24 hours)

    Time frame: 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)

  5. Rescue analgesia

    Time frame: 24 hours

    The patient's first request for postoperative analgesia

  6. Opioid intake

    Time frame: 24 hours

    The patient's opioid intake in the 24-h after surgery

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 21, 2024
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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