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STUDYING LOW BACK PAIN IN MOTHERS WHO WILL HAVE DELIVERY BY OPERATION AND PAIN REDUCTION IS DONE BY GIVING INJECTION IN THE BACK BY TWO DIFFERENT TECHNIQUES

A PROSPECTIVE RANDOMISED PARALLEL GROUP STUDY COMPAIRING INCIDENCE OF NEWLY DEVELOPED POSTOPERATIVE LOW BACK PAIN BETWEEN MEDIAN AND PARAMEDIAN APPROACH FOR SPINAL ANAESTHESIA IN OBSTETRICS - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/060090
Enrollment
170
Registered
2023-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: 1- Obstetrics

Interventions

Intervention1: Midline/Median approach spinal anaesthesia: Group M will receive 0.5% Hyperbaric Bupivacaine 2.5 ml (5mg/ml) with Fentanyl 30 µg as an adjuvant through Median technique spinal anesthesi

Sponsors

Office of the Principal Midnapore Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant Patients with ASA grade II. 2. Age group between 18-45 years of age. 3. Patients with height between 150 to 180 cm and body weight between 50 to 80 kg, BMI between 18 to 24.9 kg/m2 4. Cases undergoing caesarean section delivery under spinal anesthesia. 5. Duration of caesarean section surgeries within 90 minutes

Exclusion criteria

Exclusion criteria: 1. Refusal of the patient to give consent. 2. Local infection at the site of injection. 3. Bloody prick. 4. Having previous H/O-Backache. 5. Patient needed conversion to general anaesthesia after giving subarachnoid block. 6. History of allergy or hypersensitivity to spinal drugs. 7. Patients with any neuropathy or neurological disorder. 8. Not more than 02(Two) attempts of spinal anesthesia. 9. Psychiatric disorder. 10. Any patient with cardio respiratory disorder. 11. Any patient with hepato-renal disorder. 12. Any patient with endocrine disorder.

Design outcomes

Primary

MeasureTime frame
To compare incidences of newly developed low back pain amongst the obstetric patients who had undergone spinal anesthesia for their caesarean section deliveries with median versus paramedian approach and with the same 25 Gauze Quincke tip edges.Timepoint: 2 hours, 4 hours, 10 hours, 14 hours, 18 hours, 22 hours, 24 hours and 48 hours after surgery and at 7 days before discharge and on day 30 via telephonic conversation

Secondary

MeasureTime frame
The degree of pain in Visual Analogue Scale (VAS).Timepoint: 2 hours, 4 hours, 10 hours, 14 hours, 18 hours, 22 hours, 24 hours and 48 hours after surgery and at 7 days before discharge and on day 30 via telephonic conversation;The post dural puncture headache associated with spinal anesthesia.Timepoint: 2 hours, 4 hours, 10 hours, 14 hours, 18 hours, 22 hours, 24 hours and 48 hours after surgery and at 7 days before discharge and on day 30 via telephonic conversation;The time span to start of newly developed low back pain from spinal anaesthesia needle insertion technique and also its recovery.Timepoint: 2 hours, 4 hours, 10 hours, 14 hours, 18 hours, 22 hours, 24 hours and 48 hours after surgery and at 7 days before discharge and on day 30 via telephonic conversation;To monitor and compare the hemodynamic effects in terms of post operative systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure, heart rate including the effects of spinal anaesthesia surge on the cardiovascular system.Timepoint: 2 hours, 4 hours, 10 hours, 14 hours, 18 hours, 22 hours, 24 hours and 48 hours after surgery;To monitor and compare the post-operative complications like post operative surgical site infection, any other adverse reactions, incidence of any residual paralysis or complete lower limb paralysis after giving spinal anaesthesia.Timepoint: 2 hours, 4 hours, 10 hours, 14 hours, 18 hours, 22 hours, 24 hours and 48 hours after surgery and at 7 days before discharge and on day 30 via telephonic conversation

Countries

India

Contacts

Public ContactAsim Kumar Maiti

Midnapore Medical College and Hospital

sumanc24@gmail.com9830234881

Outcome results

None listed

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