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To compare the effects of Nalbuphine and fentanyl as spinal additives

TO COMPARE THE EFFICACY OF INTRATHECAL NALBUPHINE VERSUS FENTANYL AS ADJUVANT TO 0.5% HYPERBARIC BUPIVACAINE IN PARTURIENTS UNDERGOING ELECTIVE LSCS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046720
Enrollment
30
Registered
2022-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Health Condition 1: O748- Other complications of anesthesiaduring labor and delivery

Interventions

Intervention1: NALBUPHINE: NALBUPHINE IS GIVEN AS ADJUVANT TO 0.5% HYPERBARIC BUPIVACAINE IN PARTURIENTS UNDERGOING ELECTIVE LSCS FOR A PERIOD OF 6 MONTHS Control Intervention1: NALBUPHINE: NALBUPHIN

Sponsors

DR THEJASVI B R
Lead Sponsor
DR DAYANANDA V P
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.PARTURIENTS WILLING TO GIVE WRITTEN INFORMED CONSENT 2.SUBARACHNOID BLOCK BELONGING TO ASA I AND II 3.WOMEN WITH SINGLETON PREGNANCY CONFIRMED ON ANTENATAL ULTRASOUND 4.PREGNANT WOMEN WITH HEIGHT RANGING BETWEEN 150-180CM AND HEIGHT 50-90KG

Exclusion criteria

Exclusion criteria: 1.PATIENTS UNDERGOING EMERGENCY LSCS 2.PATIENTS WITH MEDICAL AND OBSTRETRIC COMPLICATIONS LIKE ANAEMIA, HEART DISEASE, PRE-ECLAMPSIA AND ECLAMPSIA, GESTATIONAL DIABETES ,SHOCK,SEPTICEMIA,BLEEDING DIATHESIS,LOCAL INFECTION 3.ANY HYPERSENSITIVITY REACTION TO STUDY DRUGS 4.SUBJECTS HAVING ABSOLUTE COMPLICATIONS FOR SPINAL ANAESTHESIA 5.CONGENITAL ANOMALIES DIAGNOSED ON ANTENATAL ULTRASOUND 6.FAILURE OF SPINAL BLOCKADE

Design outcomes

Primary

MeasureTime frame
1.ONSET OF SENSORY BLOCKAD 2.ONSET OF MOTOR BLOCKADE 3.TOTAL DURATION OF ANALGESIATimepoint: 5mins 6mins 4hrs

Secondary

MeasureTime frame
MAXIMUM LEVEL OF SENSORY BLOCK AND TIME TAKEN MAXIMUM MOTOR BLOCKADE AND TIME TAKEN FOR THE SAME ANALGESIC REQUIREMENT FOR FIRST 24HRS POSTOPERATIVELYTimepoint: 5min 6min 3hrs 24hrs

Countries

India

Contacts

Public ContactDR DAYANANDA V P

BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE

vpd921@yahoo.com

Outcome results

None listed

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