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A clinical study to measure the incidence and severity of pain during the operative period of pregnant patients undergoing caesarean section operation under spinal anaesthesia

THE INCIDENCE AND SEVERITY OF INTRAOPERATIVE PAIN DURING CAESAREAN SECTION UNDER SPINAL ANAESTHESIA -A PROSPECTIVE SINGLE CENTRE OBSERVATIONAL STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/03/050984
Enrollment
200
Registered
2023-03-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Health Condition 1: O82- Encounter for cesarean delivery without indication

Interventions

None listed

Sponsors

Dr Kironmoyee Barua
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with singleton, full-term, uncomplicated pregnancy undergoing cesarean section under spinal anaesthesia. 2. Lucas category 3 and 4. 3. Patients with ASA status II. 4. Patients in the age group of 18-35 years. 5. Patients who have given informed and written consent. 6. Patients with BMI 18.5 kg/m2 -24.9 kg/m2.

Exclusion criteria

Exclusion criteria: 1. Patient with complications including gestational diabetes, pregnancy related hypertensive diseases like pre-eclampsia, eclampsia, suspected abnormal placentation, multiple gestation, cardiovascular, cerebrovascular and renal diseases. 2. Patients undergoing emergency caesarean section for maternal or foetal distress 3. History of allergy to LAs or opioids 4. Patients with drug/ alcohol abuse 5. Patientâ??s refusal or unable to fill out the questionnaire. 6. Patients with failed or partial block, prior to the beginning of surgery. 7. Absolute or relative contraindication for spinal anaesthesia. 8. Patients with fetal anomalies.

Design outcomes

Primary

MeasureTime frame
To evaluate the incidence of intraoperative pain in patients of Lucas category 3 and 4 undergoing caesarean section under spinal anaesthesia.Timepoint: Parturients will be approached in the post-anaesthesia care unit and ask to fill out a questionnaire regarding intraoperative pain.

Secondary

MeasureTime frame
To determine the interventions undertaken by the anaesthesiologist for the management of intra-operative pain.Timepoint: The anaesthesiologists will be asked about the interventions undertaken by them for the management of intraoperative pain.;To determine the severity of intraoperative pain in patients of Lucas category 3 and 4 undergoing caesarean section under spinal anaesthesia.Timepoint: Parturients will be approached in the post-anaesthesia care unit and ask to fill out a questionnaire regarding intraoperative pain. . Intraoperative pain will be assessed on a visual numeric scale.;To determine whether physicians correctly assess intraoperative pain.Timepoint: The anaesthesiologist and the obstetrician will be given a questionnaire to fill out regarding intraoperative parturient pain.

Countries

India

Contacts

Public ContactDr Kironmoyee Barua

Gauhati Medical College and Hospital

aldiona.shanpru1958@gmail.com9101813237

Outcome results

None listed

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