Comparing the post operative analgesic effectiveness of bupivacaine-dexmedetomidine versus bupivacaine-fentanyl combination in thoracic epidural for midline laparotomies.

Post Operative Analgesic Efficacy of Dexmedetomidine V/S fentanyl as an Adjuvant to Bupivacaine in Thoracic Epidural for Midline Laparotomies - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/081474

Enrollment

Registered

2025-02-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: K631- Perforation of intestine (nontraumatic) Health Condition 2: K566- Other and unspecified intestinal obstruction Health Condition 3: K46- Unspecified abdominal hernia

Interventions

Intervention1: Thoracic epidural for post operative analgesic efficacy in midline laparotomies: Under all aseptic conditions, an epidural catheter was inserted via 16 G or 18 G Toheys needle using LOR

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients in age group 18-70 years. 2. Posted for elective laparotomy. 3. BMI 18-30 Kg/m2. 4. ASA grade I, II, III.

Exclusion criteria

Exclusion criteria: 1. Patient refusal. 2. Known allergy to drug used in the study. 3. Patient with ASA grade IV and above. 4. Pre-existing intrinsic or idiopathic coagulopathy. 5. Hepatic, renal or cardiorespiratory failure. 6. Patients with an increase in intracranial pressure. 7. Skin or soft tissue infection at the proposed site of needle insertion. 8. Severe hypovolemia. 9. Pre-existing neurological disease. 10. Emergency laparotomy surgeries. 11. Surgeries lasting for more than 3 hrs.

Design outcomes

Primary

Measure	Time frame
To compare dexmedetomidine and fentanyl as an adjuvant for bupivacaine in thoracic epidural in terms of duration of post operative analgesia in first 24 hours.Timepoint: Evaluate on the basis of NRS score at different intervals in first 24 hours 30 mins, 1 hour, 2 hours, 3 hours, 6 hours, 9 hours, 12 hours, 18 hours and 24 hours.	—

Secondary

Measure	Time frame
1. Peri-operative hemodynamic stability 2. Post-operative sedation score 3. Side effects and complications related to drugs and procedure.Timepoint: 1. Intra-operative heart rate, SBP, DBP, MAP, spO2 before intubation, thoracic epidural analgesic given(T0), 5 min, 10 min, 15 min, 30 min, 1 hour, 1 hour 30 min, 2 hours, 2 hour 30 min, 3 hours, immediate post intubation. 2. Post operative heart rate, SBP, DBP, MAP, spO2 in the first 24 hours 30 mins, 1 hour, 2 hours, 3 hours, 6 hours, 9 hours, 12 hours, 18 hours and 24 hours. 3. Post operative sedation score in first 24 hours 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours.	—

Measure

Time frame

1. Peri-operative hemodynamic stability 2. Post-operative sedation score 3. Side effects and complications related to drugs and procedure.Timepoint: 1. Intra-operative heart rate, SBP, DBP, MAP, spO2 before intubation, thoracic epidural analgesic given(T0), 5 min, 10 min, 15 min, 30 min, 1 hour, 1 hour 30 min, 2 hours, 2 hour 30 min, 3 hours, immediate post intubation. 2. Post operative heart rate, SBP, DBP, MAP, spO2 in the first 24 hours 30 mins, 1 hour, 2 hours, 3 hours, 6 hours, 9 hours, 12 hours, 18 hours and 24 hours. 3. Post operative sedation score in first 24 hours 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours.

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Countries

India

Contacts

Public ContactDr Kiwi Mantan

Sardar Patel Medical College

kiwivyas@gmail.com9929092702

Outcome results

None listed

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