Post Operative PainPhase 3NCT06650891
Quercetin Effect on Post-ceserean Pain
A Phase 3 study testing Quercetin in people with Post Operative Pain and Cesarean Section Complications, run by Future University in Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Post Operative Pain, Cesarean Section Complications
- What is being tested?
- Quercetin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2024to 27 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred to elective (non-emergency) cesarean section
- Undergoing spinal anesthesia) with American Society of Anesthesiologists (ASA) classification I and II
- Term gestational age
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Quercetin, Placebo
- Keywords
- post-operative pain, Cesarean section, quercetin, opioid use
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuercetinDrug
oral quercetin prior to surgery
PlaceboOther
capsule identical looking to quercetin
| Study group | Role | What they receive |
|---|---|---|
| Quercetin | Experimental | receive 500mg of oral quercetin 1 hour preoperatively. Receives: Drug: Quercetin |
| Placebo | Placebo comparator | receive placebo 1 hour preoperatively Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (2 hours)
Pain intensity using 10 cm Visual analog scale (VAS) scale
Measured: 2 hours
Pain intensity (6 hours)
Pain intensity using 10 cm Visual analog scale (VAS) scale
Measured: 6 hours
Pain intensity (12 hours)
Pain intensity using 10 cm Visual analog scale (VAS) scale
Measured: 12 hours
Pain intensity (24 hours)
Pain intensity using 10 cm Visual analog scale (VAS) scale
Measured: 24 hours
Secondary outcomes (6)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 24 hours
Rescue analgesia
The patient's first request for postoperative analgesia
Measured: 24 hours
Opioid intake
The patient's opioid intake in the 24-h after surgery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start30 Oct 2024
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Omar El Said, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650891
- Sponsor's protocol ID
- RFC-PH-3/2024
- Status last verified
- Feb 2025
- First submitted
- 18 Oct 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40687903
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjunctive Effect of Quercetin on Postoperative Pain Management Following Cesarean Section
- ClinicalTrials.gov ID
- NCT06650891
- Acronym / sponsor ID
- RFC-PH-3/2024
- Keywords
- post-operative pain, Cesarean section, quercetin, opioid use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quercetin | Experimental | Drug: Quercetinreceive 500mg of oral quercetin 1 hour preoperatively. |
| Placebo | Placebo comparator | Other: Placeboreceive placebo 1 hour preoperatively |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Referred to elective (non-emergency) cesarean section
- Undergoing spinal anesthesia) with American Society of Anesthesiologists (ASA) classification I and II
- Term gestational age
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quercetinoral quercetin prior to surgery | Drug | Quercetin |
| Placebocapsule identical looking to quercetin | Other | Placebo |
Primary outcome
Pain intensity (2 hours)
Time frame: 2 hours
Pain intensity using 10 cm Visual analog scale (VAS) scale
Pain intensity (6 hours)
Time frame: 6 hours
Pain intensity using 10 cm Visual analog scale (VAS) scale
Pain intensity (12 hours)
Time frame: 12 hours
Pain intensity using 10 cm Visual analog scale (VAS) scale
Pain intensity (24 hours)
Time frame: 24 hours
Pain intensity using 10 cm Visual analog scale (VAS) scale
6 secondary outcomes
Nausea & vomiting (2 hours)
Time frame: 2 hours
Nausea & vomiting (6 hours)
Time frame: 6 hours
Nausea & vomiting (12 hours)
Time frame: 12 hours
Nausea & vomiting (24 hours)
Time frame: 24 hours
Rescue analgesia
Time frame: 24 hours
Opioid intake
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Derived from this study: PubMed 40687903Mohamed 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.
- Individual participant dataSharing planned: No
Related trials for Post Operative Pain
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
RecruitingPhase 2/3
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Pain, Postoperative
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Active, not recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quercetin in people with Post Operative Pain and Cesarean Section Complications, run by Future University in Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (2 hours) (time frame: 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06650891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.