Clinical trial NCT06650891: Quercetin Effect on Post-ceserean Pain
Official title: The Adjunctive Effect of Quercetin on Postoperative Pain Management Following Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Operative Pain
Cesarean Section Complications
Keywords: post-operative pain
Cesarean section
quercetin
opioid use
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity (2 hours)
timeFrame: 2 hours
measure: Pain intensity (6 hours)
timeFrame: 6 hours
measure: Pain intensity (12 hours)
timeFrame: 12 hours
measure: Pain intensity (24 hours)
timeFrame: 24 hours
Secondary outcomes:
measure: Nausea & vomiting (2 hours)
timeFrame: 2 hours
measure: Nausea & vomiting (6 hours)
timeFrame: 6 hours
measure: Nausea & vomiting (12 hours)
timeFrame: 12 hours
measure: Nausea & vomiting (24 hours)
timeFrame: 24 hours
measure: Rescue analgesia
timeFrame: 24 hours
measure: Opioid intake
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: El Matarya Teaching Hospital,
Study officials:
References: