effeciency of 0.25%Levobupivacaine versus 0.25%Levobupivacaine with Dexmedetomidine(local anaesthetic)inside abdomen using pain scale after laparoscopic cholecystectomy operation

Analgesic effectiveness of periportal and intraperitoneal infiltration of 0.25%Levobupivacaine versus 0.25%Levobupivacaine with Dexmedetomidine using Visual analog scale in post laparoscopic cholecystectomy - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075463

Enrollment

110

Registered

2024-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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: Periportal and Intraperitoneal infiltration of 0.25% Levobupivacaine with Dexmedetomidine: GROUP B: Patient will receive intraperitoneal instillation of 20ml solution of of 0.25% levo

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients of ASA 1 and 2 of either sex 2)Patients aged 20yrs to 60yrs 3)Patient undergoing elective laparoscopic cholecystectomy surgery under GA with endotracheal tube

Exclusion criteria

Exclusion criteria: 1)Patient of ASA 3 AND 4 OF EITHER SEX 2)PATIENT AGED LESS THAN 20YRS AND ABOVE 60YRS 3)ABDOMEN DRAIN INSITU 4)PATIENT WITH KNOWN ALLERGY TO LOCAL ANAESTHETICS 5)PATIENT WITH COAULATION DISORDERS 6)PATIENT WITH SPINE DEFORMITIES OR SKIN INFECTION AT LOCAL SITES 7)Patients with severe cardiopulmonary, renal or liver disease, and morbidly obese BODY MASS INDEX MORE THAN 25kg per metre square.

Design outcomes

Primary

Measure	Time frame
(a)To assess the intensity of pain in the first 24 hours after periportal and intraperitoneal infiltration of 0.25% levobupivacaine alone versus 0.25% levobupivacaine with dexmedetomidine 1 µg/kg using visual analog scale at 1/2hr, 1st hr, 2nd hr, 4th hr, 6th hr, 12th and 24 hr. (b)To know total analgesic consumption and number of times the requirement of rescue analgesia in post-op care within 24 hours. (c)To compare time to the first request of analgesia in post-op care within 24 hours. Timepoint: (a)To assess the intensity of pain in the first 24 hours after periportal and intraperitoneal infiltration of 0.25% levobupivacaine alone versus 0.25% levobupivacaine with dexmedetomidine 1 µg/kg using visual analog scale at 1/2hr, 1st hr, 2nd hr, 4th hr, 6th hr, 12th and 24 hr. (b)To know total analgesic consumption and number of times the requirement of rescue analgesia in post-op care within 24 hours. (c)To compare time to the first request of analgesia in post-op care within 24 hours.	—

Measure

Time frame

(a)To assess the intensity of pain in the first 24 hours after periportal and intraperitoneal infiltration of 0.25% levobupivacaine alone versus 0.25% levobupivacaine with dexmedetomidine 1 µg/kg using visual analog scale at 1/2hr, 1st hr, 2nd hr, 4th hr, 6th hr, 12th and 24 hr. (b)To know total analgesic consumption and number of times the requirement of rescue analgesia in post-op care within 24 hours. (c)To compare time to the first request of analgesia in post-op care within 24 hours. Timepoint: (a)To assess the intensity of pain in the first 24 hours after periportal and intraperitoneal infiltration of 0.25% levobupivacaine alone versus 0.25% levobupivacaine with dexmedetomidine 1 µg/kg using visual analog scale at 1/2hr, 1st hr, 2nd hr, 4th hr, 6th hr, 12th and 24 hr. (b)To know total analgesic consumption and number of times the requirement of rescue analgesia in post-op care within 24 hours. (c)To compare time to the first request of analgesia in post-op care within 24 hours.

—

Secondary

Measure	Time frame
(a)To assess any shoulder tip pain if present due to pneumoperitoneum. (b)To assess post-op nausea vomiting, pruritis, bradycardia, hypotension. Timepoint: yes or no To assess the intensity of pain in the first 24 hours after periportal & intraperitoneal infiltration of 0.25% levobupivacaine alone versus 0.25% levobupivacaine with dexmedetomidine 1 µg/kg using visual analog scale at 1/2hr, 1st hr, 2nd hr, 4th hr, 6th hr, 12th & 24 hr.	—

Measure

Time frame

(a)To assess any shoulder tip pain if present due to pneumoperitoneum. (b)To assess post-op nausea vomiting, pruritis, bradycardia, hypotension. Timepoint: yes or no To assess the intensity of pain in the first 24 hours after periportal & intraperitoneal infiltration of 0.25% levobupivacaine alone versus 0.25% levobupivacaine with dexmedetomidine 1 µg/kg using visual analog scale at 1/2hr, 1st hr, 2nd hr, 4th hr, 6th hr, 12th & 24 hr.

—

Countries

India

Contacts

Public ContactMeghnaPrakash

IMS AND SUM HOSPITAL

jagadish.jena2@gmail.com919437748423

Outcome results

None listed

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