Post-operative pain relief in laparoscopic cholecystectomy, comparison between Opioid-free anaesthesia vs Opioid anaesthesia

Post-operative pain relief in laparoscopic cholecystectomy, comparison between Opioid-free anaesthesia using injection Dexmedetomidine infusion and injection Lidocaine bolus vs Opioid anaesthesia using injection Fentanyl: A Randomized Controlled Prospective, Double Blind Study. - nil

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056874

Enrollment

110

Registered

2023-08-24

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: Opioid free analgesia using inj dexmedetomidine infusion and inj lidocaine bolus: Opioid free analgesia using inj. dexmedetomidine infusion at 0.7mcg/kg loading dose over 10 min in 10

Eligibility

Inclusion criteria

Inclusion criteria: All patients coming for laparoscopic cholecystectomy surgery of American Society of Anesthesiologists Grade I-II patients

Exclusion criteria

Exclusion criteria: 1.BMI: 35 and above 2.Second degree Heart block and above 3.Bradycardia and hypotension 4.Diabetes 5.Psychiatric disease 6.History of chronic pain 7.Alcohol or drug abuse 8.Allergy to any of a drug in the study groups 9.Pregnant, breast-feeding or menstruating women 10.Any analgesic or antiemetic use in last 24 hours before anaesthesia induction

Design outcomes

Primary

Measure	Time frame
To compare pain relief in post operative period using visual analogue scale for 24 hour during rest at 0, 2, 4, 6, 12, 24 hours & at movement (coughing & lateral decubitus position )at 6, 12, 24 hoursTimepoint: 24 hours post operative period	—

Secondary

Measure	Time frame
1. Comparison of intra-operative hemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure & mean arterial pressure) between 2 groups at just before induction & at 5, 15, 30, 60 min after induction for all patients. 2. Compare total rescue analgesic requirements between 2 groups in first 24 hours.( rescue non-opioid analgesic Inj. Diclofenac 75mg will be given If VAS more than 4, those patients with persistent severe pain [VAS more than 8-10],opioid analgesia in form of Inj. Tramadol 50 mg.) 3. Postoperative nausea & vomiting will be noted and graded according to standard PONV scoring system. Timepoint: intraoperative hemodynamic before induction & at 5, 15, 30, 60 min after induction for all patients.	—

Measure

Time frame

1. Comparison of intra-operative hemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure & mean arterial pressure) between 2 groups at just before induction & at 5, 15, 30, 60 min after induction for all patients. 2. Compare total rescue analgesic requirements between 2 groups in first 24 hours.( rescue non-opioid analgesic Inj. Diclofenac 75mg will be given If VAS more than 4, those patients with persistent severe pain [VAS more than 8-10],opioid analgesia in form of Inj. Tramadol 50 mg.) 3. Postoperative nausea & vomiting will be noted and graded according to standard PONV scoring system. Timepoint: intraoperative hemodynamic before induction & at 5, 15, 30, 60 min after induction for all patients.

—

Countries

India

Contacts

Public ContactMamta chadha

Northern railway central hospital

mamtachadha@rediffmail.com9717630526

Outcome results

None listed

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