A study where vomiting after cesarean operation is compared among 3 groups who receive spinal anesthesia by 3 different drugs

A Prospective, Randomized, Parallel Group Study of Comparison of Post Operative Nausea and Vomiting and other clinical effects of Bupivacaine with Levobupivacaine and Ropivacaine in patients posted for Emergency LUCS under Spinal Anaesthesia - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064486

Enrollment

600

Registered

2024-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Spinal Anaesthesia with inj. Ropivacaine heavy: All patients in this group will receive spinal anaesthesia with 2.4ml Inj. ropivacaine (0.75%) heavy at L3-L4 space with co-loading of ri

Eligibility

Inclusion criteria

Inclusion criteria: ASA Grade 2 patients Patients providing valid inform consent Patients undergoing Emergency LUCS under spinal anaesthesia

Exclusion criteria

Exclusion criteria: Patients who do not give valid consent Patients with complicated pregnancy Patients with coagulopathies Patient with features of shock Patients with local site infection Patients with history of motion sickness Patient with psychiatric problems or communication problems Patients with failed spinal anaesthesia Patients with blood pricked spinal anaesthesia Duration of surgery more than 90 minutes

Design outcomes

Primary

Measure	Time frame
Incidence of post operative nausea and vomiting among the study groupsTimepoint: 0, 2, 6, 12 , 24 hours after completion of surgery	—

Secondary

Measure	Time frame
Hemodynamic changes amongst the study groups that is Systolic blood pressure, diastolic blood pressure, mean blood pressure, heart rate in the intraoperative periodTimepoint: 0,2,4,6,8,10,12,14,16,18,20,30,40,50,60,70,80,90 mins after spinal anaesthesia or till completion of surgery;Onset and degree of motor block, onset and degree of sensory blockTimepoint: 0,1,2,3,4,5,6,7,8,9,10 mins after spinal anaesthesia;Patient satisftaction score in relation to pain reduction and post operative nausea vomiting reductionTimepoint: 24 hours after surgery;Requirement of rescue anti-emetic in the first 24 hoursTimepoint: 24 hour after completion of surgery;Surgeon satisfaction scoreTimepoint: after completion of surgery;Time taken for first mobilisation post operation and time taken for first passage of flatus post operationTimepoint: 0, 0.5, 1,1.5,2,2.5,3,3.5,4,4.5,5,5.5,6,6.5,7,7.5,8,8.5,9,9.5,10,10.5, 11,11.5,12,12.5,13,13.5,14,14.5,15,15.5,16,16.5,17,17.5,18,18.5,19,19.5,20,20.5,21,21.5,22,22.5,23,23.5,24 hours after completion of surgery	—

Measure

Time frame

Hemodynamic changes amongst the study groups that is Systolic blood pressure, diastolic blood pressure, mean blood pressure, heart rate in the intraoperative periodTimepoint: 0,2,4,6,8,10,12,14,16,18,20,30,40,50,60,70,80,90 mins after spinal anaesthesia or till completion of surgery;Onset and degree of motor block, onset and degree of sensory blockTimepoint: 0,1,2,3,4,5,6,7,8,9,10 mins after spinal anaesthesia;Patient satisftaction score in relation to pain reduction and post operative nausea vomiting reductionTimepoint: 24 hours after surgery;Requirement of rescue anti-emetic in the first 24 hoursTimepoint: 24 hour after completion of surgery;Surgeon satisfaction scoreTimepoint: after completion of surgery;Time taken for first mobilisation post operation and time taken for first passage of flatus post operationTimepoint: 0, 0.5, 1,1.5,2,2.5,3,3.5,4,4.5,5,5.5,6,6.5,7,7.5,8,8.5,9,9.5,10,10.5, 11,11.5,12,12.5,13,13.5,14,14.5,15,15.5,16,16.5,17,17.5,18,18.5,19,19.5,20,20.5,21,21.5,22,22.5,23,23.5,24 hours after completion of surgery

—

Countries

India

Contacts

Public ContactDr Debaleena Jana

Midnapore Medical College and Hospital

sumanc24@gmail.com9830234881

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026