Comparing early v/s late Injection levobupivacaine application on pain relief in laparoscopic cholecystectomy

Effect of Early V/s Late Port Site Levobupivacaine infiltration along with Intraperitoneal Instillation on Postoperative Pain in Patients Undergoing Elective Laparoscopic Cholecystectomy under General Anaesthesia: A Randomised Study - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/096805

Enrollment

Registered

2025-11-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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: Inj levobupivacaine 0.25% in 20ml local infiltrationbefore incision: Patients will be administered port site infiltration of levobupivacaine, group E and Group L

group E will receive Levobupivacaine early,i.e, preincisional and Group L will receive levobupivacaine before skin closure. Total 20ml of 0.25% of drug will be used on 4 port sites

umblical port{6ml}, epigastric port{6ml}, subcostal port mid clavicular line{4ml}, subcostal port anterior axillary line{6ml}. Control Intervention1: INJ LEVOBUPICVACAINE[ 0.25% 20ML]: EARLY V/S LATE

Eligibility

Inclusion criteria

Inclusion criteria: :18 to 65 years with American Society of Anesthesiologists (ASA I and II), male or female, scheduled for elective abdominal laparoscopic cholecystectomy surgery under general anaesthesia.

Exclusion criteria

Exclusion criteria: Nonconsenting patient, patients who weigh less than 40 kg or more than 100 kg, Malignant surgeries, Pregnant and Breastfeeding patients, Patients with hepatic, renal and cardiac diseases, those with extensive intraperitoneal adhesions, a history of chronic pain medications, history of chronic alcoholism, allergy to study drugs, known hypomagnesemia or hypermagnesemia, pregnancy and lactating females, change of surgical plan such as intraoperative lavage of more than 500 mL, prolonged surgery more than 4 hours, cases converted to open laparotomies or surgical reexploration in less than 24 hours, 1 month prior papillotomy done by ERCP.

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the time to first rescue analgesia in minutes in both the groups.Timepoint: Immediately in the PACU 15min 30min 1 hr 2 hr 4hr 6hr 8hr 12hr 24hr	—

Secondary

Measure	Time frame
1. To assess and compare the Numeric Rating score at rest i.e. in supine position and during coughing at predefined intervals between the two groups. 2. To evaluate and compare total rescue analgesic consumption (Inj. Diclofenac Sodium) within the first 24 hours postoperatively. 3. To compare the incidence of side effects like bradycardia, hypotension, post-operative nausea and vomiting, shoulder tip pain between the two groups. 4. To compare the length of hospital stay between the two groups.Timepoint: Immediately in the PACU 15min 30min 1 hr 2 hr 4hr 6hr 8hr 12hr 24hr	—

Measure

Time frame

1. To assess and compare the Numeric Rating score at rest i.e. in supine position and during coughing at predefined intervals between the two groups. 2. To evaluate and compare total rescue analgesic consumption (Inj. Diclofenac Sodium) within the first 24 hours postoperatively. 3. To compare the incidence of side effects like bradycardia, hypotension, post-operative nausea and vomiting, shoulder tip pain between the two groups. 4. To compare the length of hospital stay between the two groups.Timepoint: Immediately in the PACU 15min 30min 1 hr 2 hr 4hr 6hr 8hr 12hr 24hr

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Countries

India

Contacts

Public ContactDr Pranita Mandal

All India Institute Of Medical Sciences,Bhopal

pranita.anesth@aiimsbhopal.edu.in8800768428

Outcome results

None listed

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