Health Condition 1: O30-O48- Maternal care related to the fetus and amniotic cavity and possible delivery problems
Conditions
Interventions
Intervention1: Intrathecal Morphine: This intervention group receives subarachnoid injection of Bupivacaine heavy (10-11mg, discretion of anaesthesiologist) with 20?g fentanyl, with 100 ?g preservativ
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Parturients more than 18 years undergoing elective caesarean delivery under spinal anesthesia. ASA physical status II-III. Able to provide informed consent & complete questionnaire in Hindi
Exclusion criteria
Exclusion criteria: Patient refusal Contraindication to spinal anesthesia, ITM or TAP block General anesthesia planned/required Chronic opioid use Significant hepatic/renal impairment Coagulopathy BMI more than 40 kg/m? Patient at extremes of height. Active infection at injection sites Medical illness which requires admission high dependency unit Medical barrier which would prevent patient from completing the ObsQoR form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the quality of recovery at 24 hours post cesarean delivery, measured by the total ObsQoR-11Hindi score, between patients randomized to receive ITM versus those randomized to receive TAP block, within a non-inferiority framework. Timepoint: To compare the quality of recovery at 24 hours post cesarean delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity with movement (NRS 0-10) (e.g., during transfer/coughing) at 3, 6, 12 and 24 hours post-delivery. Time to first request for rescue opioid analgesia (in minutes). Total cumulative iv tramadol consumption during first 24 hours post delivery. Incidence and severity of PONV (e.g., using PONV Impact Scale) after delivery, followed by 3, 6, 12, 24 hours post delivery. Incidence and severity of Pruritus (using 4 point scale) recorded prospectively over 24 hours. Incidence of respiratory depression. Time (hours) from end of surgery to first independent ambulation (e.g., walking to bathroom) Time (hours) from end of surgery to first passage of flatus. Timepoint: 3,6,12 and 24hrs | — |
Countries
India
Contacts
Public ContactDr Anshul Singh
AIIMS New Delhi
Outcome results
None listed