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Nalbuphine and Fentanyl a comparative study in infraumbilical surgeries

Comparison Between Nalbuphine And Fentanyl As Adjuvants To Intrathecal Bupivacaine In Patients Undergoing Infraumbilical Surgeries: A Prospective Randomized Control Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/016945
Enrollment
70
Registered
2019-01-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: N938- Other specified abnormal uterine and vaginal bleeding

Interventions

Intervention1: intervention drugs: intrathecal Nalbuphine 1mg: Group (A) (Nalbuphine) - Intrathecal Bupivacaine (0.5% hyperbaric) 3ml and intrathecal Nalbuphine (1mg),single dose,total drug voulume 3.

Sponsors

MOSC medical CollegeKolenchery
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 20-60 years of either gender. 2.American Society of Anaesthesiologists (ASA) grade 1 and 2 patients. 3.Patients undergoing elective infraumbilical surgeries like abdominal hysterectomy, open inguinal hernia repair under spinal anesthesia

Exclusion criteria

Exclusion criteria: 1.known hypersensitivity to any of the study drugs. 2.Contraindications to central neuraxial block 3.Pregnancy

Design outcomes

Primary

MeasureTime frame
1) To compare the duration of analgesia between Nalbuphine and Fentanyl as adjuvants to intrathecal hyperbaric 0.5% Bupivacaine in patients undergoing infraumbilical surgeriesTimepoint: Verbal numerical pain rating scale score(Verbal NPRS score) Before spinal At incision Post incision min 30 min 60 min 90 min 120 min 150 min 180 PACU(Hourly):4th,5th,6th,7th 8th hr 12th hr 16th hr—

Secondary

MeasureTime frame
1)To compare the onset of sensory and motor blockade between Nalbuphine and Fentanyl as adjuvants to intrathecal hyperbaric 0.5% Bupivacaine 2)To compare the duration of sensory and motor blockade between Nalbuphine and Fentanyl as adjuvants to intrathecal hyperbaric 0.5% Bupivacaine in patients undergoing infraumbilical surgeries 3)To compare hemodynamic changes and adverse events between Nalbuphine and Fentanyl as adjuvants to intrathecal hyperbaric 0.5% Bupivacaine Timepoint: Sensory block onset time:at the time of spinal, then every 2minutes post spinal motor block onset time:every minute after spinal block, using modified bromage scale. duration of sensory block: time difference between onset and complete recovery of sensory block duration of motor block: time difference between onset and complete recovery of motor block HR,NIBP,RR,SpO2,temperature Spinal time(0),post spinal(minutes) 5, 10 ,15, 20, 25, 30, 45, 60, 75, 90, 105, 120, 150, 180,—

Countries

India

Contacts

Public ContactSona Bharathan PV

MOSC medical College,Kolenchery

sunutg97@yahoo.co.in9656277614

Outcome results

None listed

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