Cesarean Section Pain, Postoperative Pain
Conditions
Keywords
Cesarean Pain, Multimodal Analgesia, Spinal Anesthesia, Dexmedetomidine, Ketamine, Postoperative pain
Brief summary
This study aims to compare three different doses of dexmedetomidine, when combined with a fixed dose of ketamine, for pain control in women undergoing cesarean section. The goal is to find the most effective combination with the fewest side effects.
Detailed description
Caesarean section is associated with moderate-to-severe postoperative discomfort in a significant proportion of women, which can delay recovery and return to regular activities, disrupt mother-child bonding, affect maternal psychological well-being, and impede nursing. Furthermore, inadequate surgical pain treatment may result in hyperalgesia and chronic pain. Due to widespread misconceptions that analgesic medications or procedures may have detrimental effects on the mother or newborn, and because the severity of post-caesarean section pain is typically underestimated, pain following caesarean section is frequently under-treated. Various analgesic therapy techniques include oral or parenteral opioids, nonsteroidal anti-inflammatory medications, and neuraxial blocks with or without adjuvants, with unclear efficacy and/or substantial adverse effects. While opioids are the gold standard for postoperative pain management, they are associated with respiratory depression, nausea, vomiting, and other adverse effects that increase patient suffering. In recent years, there has been a shift toward minimizing opioid use and developing guidelines for enhanced postpartum recovery. Studies have explored combining opioids with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), ketamine, clonidine, and dexmedetomidine for effective pain relief while avoiding opioid-related side effects. Dexmedetomidine, a highly selective α2-agonist, is beneficial in reducing tension and anxiety. It may be effective in the management of postoperative pain due to its analgesic properties. Dexmedetomidine acts at spinal and supraspinal sites, producing antinociceptive effects via stimulation of α2-receptors in the locus coeruleus. Ketamine has been shown to be an effective painkiller with few side effects when used in small doses. Its analgesic effects result from N-methyl-D-aspartate (NMDA) receptor antagonism, and it also interacts with opioid receptors in the brain and spinal cord. When combined with benzodiazepines, ketamine's adverse effects are further minimized. The combination of ketamine and dexmedetomidine offers several benefits, including hemodynamic stability, absence of respiratory depression, improved postoperative analgesia, and smoother recovery. Previous work has demonstrated a synergistic effect when these agents are used together, providing excellent symptom relief while minimizing side effects. This study seeks to address the current gap in literature regarding the comparative efficacy of different doses of dexmedetomidine combined with a fixed dose of ketamine for post-cesarean analgesia. It aims to evaluate three infusion doses of dexmedetomidine combined with ketamine using postoperative pain scores as the primary outcome measure. The findings may help optimize pain management protocols following cesarean section
Interventions
DRUGDexmedetomidine
Dexmedetomidine infusion at one of the following doses: Group A: 0.2 µg/kg/hr Group B: 0.3 µg/kg/hr Group C: 0.4 µg/kg/hr Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period
DRUGketamine
Ketamine infusion at a fixed dose of 0.25 mg/kg/hr administered in all three groups. Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period
Sponsors
Fatima Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Elective lower segment cesarean section * American Society of Anesthesiologists (ASA) Physical Status II * Provided informed consent
Exclusion criteria
* Known drug allergy * Presence of significant comorbidities * Emergency surgery * Documented psychiatric illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Postoperative Pain Score (Visual Analog Scale) | 0-24 hours post-surgery | Pain will be assessed using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain. Visual Analog Scale (VAS) scores will be recorded at 0, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Rescue Analgesia | Continuous monitoring up to 24 hours postoperative | Measured in hours from the end of surgery to the time when the first dose of rescue analgesia (Nalbuphine 0.1 mg/kg Intravenous) is administered. Time will be recorded prospectively by anesthesia staff using standardized postoperative monitoring sheets and confirmed from the medication administration records. |
| Total dose of rescue analgesia (Nalbuphine) required within 24 hours | 24 hours postoperative | Determined from direct observation and recorded in structured data collection forms by trained anesthesia personnel during the postoperative period. All doses of Nalbuphine administered will be documented in real-time and verified against the patient's medication administration records and nursing charts. |
Countries
Pakistan
Contacts
Primary ContactAhmed Naeem, MBBS
Outcome results
None listed