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A study for effectiveness of local anaesthetic drugs in abdominal hysterectomy surgery

A comparative study of 0.5% bupivacaine with fentanyl versus 0.75% ropivacaine with fentanyl in epidural anesthesia for abdominal hysterectomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/014149
Enrollment
70
Registered
2018-05-25
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: null- Awaited for abdominal hysterectomy operation

Interventions

Intervention1: Bupivacaine with Fentanyl (Local anaesthetic and opioid): A single dose 0.5% Bupivacaine with 100microgram Fentanyl drugs by route of administration epidural injection Total duration fo

Sponsors

Institute of Postgraduate Medical Education Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult female patients, aged between 30 to 65 yrs 2. BMI 18.5 to 29.9 kg/meter2 3. ASA physical status I & II. 4. Patients scheduled for elective abdominal hysterectomy under lumbar epidural anaesthesia.

Exclusion criteria

Exclusion criteria: a) Patient refusal. b) Any contraindication to epidural anaesthesia â?? i. Infection at the site of injection ii. Coagulopathy iii. Neurological disorders and psychiatric disorder iv. Haemodynamically compromised patients v. Sepsis vi. Gross anatomical abnormality of vertebral column. vii. Known allergy to either bupivacaine or ropivacaine or fentanyl. viii. Patients on chronic antiplatelet drugs and anticoagulants.

Design outcomes

Primary

MeasureTime frame
To conclude that in the present study using 0.5% bupivacaine with fentanyl and 0.75% ropivacaine with fentanyl epidurally, ropivacaine produced an earlier onset but similar duration of sensory block. The onset, quality and duration of motor block were comparable in both the groups.Timepoint: During hysterectomy operation for two hours

Secondary

MeasureTime frame
In hemodynamics, heart rate was comparable in both groups but blood pressures (SBP, MAP, DBP) was decrease significantly in bupivacaine group after 20min of administration of the epidural study drug.Timepoint: Post operative assessment for 24hours

Countries

India

Contacts

Public ContactDR OINDRILA SINHA

IPGMER, Kolkata

sankarisantra@yahoo.com

Outcome results

None listed

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