To compare drug having pain relieving action given via regional method versus given intravenously after block in patients undergoing lower abdominal surgeries

A Comparitive Study Of Dexmeditomidate Versus Fentanyl As An Additive To Bupivacaine In Ultrasound Guided Transverse Abdominis Plane Block For Patients Undergoing Lower Abdominal Surgeries

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082915

Enrollment

Registered

2025-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: DEXMEDITOMIDINE: transabdominal plane block with 20ml of 0.25% bupivacaine hydrochloride + 1ug/kg dexmedetomidine Control Intervention1: FENTANYL: transabdominal plane block with 20ml o

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA grade I or II fit patients. 2. Ages between 18 and 65 years 3. Patients undergoing lower abdominal surgeries . 4. Haemodynamically stable patients with all routine investigations within normal limits without any other co-morbidities. 5. Patients who are not on any cardiac related drugs. 6. Availability of written informed consent from concerned patient.

Exclusion criteria

Exclusion criteria: 1. Patients not willing to participate in this study. 2. Patients with ASA physical status III and above physical status. 3. Patients less than 18 years and above 65 years of age. 4. Patients with uncontrolled systemic disorders like neurological, cardiac, metabolic, renal, pulmonary disorders, hepatic disease with coagulation abnormalities etc. 5. Patients having local infection at the site where needle for block was to be inserted 6. Patients with bleeding or coagulation disorders. 7. Patients with known allergies to the study drugs.

Design outcomes

Primary

Measure	Time frame
To compare the analgesic efficacy of dexmeditomidine versus fentanyl as an additive to bupivacaine in ultrasound-guided transverse abdominis plane block in patients undergoing lower abdominal surgeries.Timepoint: After administration of the block, comparison between the two groups of onset and duration of sensory and motor blockade, duration ofanalgesia and time to rescue to analgesia will be assessed at baseline, after injection of study drug, at 5 mins, 10 mins, 15 mins, 30 mins and 10 mins after surgery.	—

Measure

Time frame

To compare the analgesic efficacy of dexmeditomidine versus fentanyl as an additive to bupivacaine in ultrasound-guided transverse abdominis plane block in patients undergoing lower abdominal surgeries.Timepoint: After administration of the block, comparison between the two groups of onset and duration of sensory and motor blockade, duration ofanalgesia and time to rescue to analgesia will be assessed at baseline, after injection of study drug, at 5 mins, 10 mins, 15 mins, 30 mins and 10 mins after surgery.

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Secondary

Measure	Time frame
To compare the analgesic efficacy of dexmeditomidine versus fentanyl as an additive to bupivacaine in ultrasound-guided transverse abdominis plane block in patients undergoing lower abdominal surgeries.Timepoint: Duration of analgesia will be assessed post surgery once the effects of the block decrease & time to rescue to analgesia will be assessed 2 hours after surgery & hourly until intervention is required	—

Measure

Time frame

To compare the analgesic efficacy of dexmeditomidine versus fentanyl as an additive to bupivacaine in ultrasound-guided transverse abdominis plane block in patients undergoing lower abdominal surgeries.Timepoint: Duration of analgesia will be assessed post surgery once the effects of the block decrease & time to rescue to analgesia will be assessed 2 hours after surgery & hourly until intervention is required

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Countries

India

Contacts

Public ContactDr Subha Vazhakalayil Jose

DR.D.Y. Patil Medical College,Hospital And Research Centre,Pimpri Pune Pune

dr.subhajose@gmail.com9558224077

Outcome results

None listed

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