NCT06650891

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

October 30, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2025

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

October 18, 2024

Last Update Submit

February 4, 2025

Conditions

Post Operative PainCesarean Section Complications

Keywords

post-operative painCesarean sectionquercetinopioid use

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Nausea & vomiting (2 hours)

    2 hours

  • Nausea & vomiting (6 hours)

    6 hours

  • Nausea & vomiting (12 hours)

    12 hours

  • Nausea & vomiting (24 hours)

    24 hours

  • Rescue analgesia

    24 hours

  • +1 more secondary outcomes

Study Arms (2)

Quercetin

EXPERIMENTAL

receive 500mg of oral quercetin 1 hour preoperatively.

Drug: Quercetin

Placebo

PLACEBO COMPARATOR

receive placebo 1 hour preoperatively

Other: Placebo

Interventions

QuercetinDRUG

oral quercetin prior to surgery

Quercetin
PlaceboOTHER

capsule identical looking to quercetin

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Matarya Teaching Hospital,

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 40687903DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Quercetin

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

FlavonolsFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in. Pharmacy Practice & Clinical Pharmacy

Study Record Dates

First Submitted

October 18, 2024

First Posted

October 21, 2024

Study Start

October 30, 2024

Primary Completion

January 27, 2025

Study Completion

January 27, 2025

Last Updated

February 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)