Skip to content

Quercetin Effect on Post-ceserean Pain

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06650891
Enrollment
80
Registered
2024-10-21
Start date
2024-10-30
Completion date
2025-01-27
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications, Post Operative Pain

Keywords

post-operative pain, Cesarean section, quercetin, opioid use

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.

Interventions

DRUGQuercetin

oral quercetin prior to surgery

OTHERPlacebo

capsule identical looking to quercetin

Sponsors

Future University in Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity (2 hours)2 hoursPain intensity using 10 cm Visual analog scale (VAS) scale
Pain intensity (6 hours)6 hoursPain intensity using 10 cm Visual analog scale (VAS) scale
Pain intensity (12 hours)12 hoursPain intensity using 10 cm Visual analog scale (VAS) scale
Pain intensity (24 hours)24 hoursPain intensity using 10 cm Visual analog scale (VAS) scale

Secondary

MeasureTime frameDescription
Rescue analgesia24 hoursThe patient's first request for postoperative analgesia
Nausea & vomiting (2 hours)2 hoursseverity 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)
Opioid intake24 hoursThe patient's opioid intake in the 24-h after surgery
Nausea & vomiting (6 hours)6 hoursseverity 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)
Nausea & vomiting (12 hours)12 hoursseverity 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)
Nausea & vomiting (24 hours)24 hoursseverity 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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026