Comparison of Intraoperative Intravenous Lidocaine Infusion and Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia Following Laproscopic Cholecystectomy

Post Operative Pain Clinical Trial

Official title:

Comparison of Intraoperative Intravenous Lidocaine Infusion and Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia Following Laproscopic Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05231941
• Other study ID #: 5515
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: January 17, 2023

Study information

• Verified date: February 2022
• Source: Aga Khan University Hospital, Pakistan
• Contact: Haris Sheikh, MBBS
• Phone: 923452432387
• Email: haris.sheikh[@]aku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is aimed to determine the post operative pain after laparoscopic cholecystectomy by dividing patients into three different group. Group A will receive lidocaine 2mg/kg bolus at induction followed by 1.5mg/kg/hr infusion. Group B will receive bilateral subcostal TAP block with 0.375% 20ml Ropivicaine on each side. Group C will not receive any additional pain regime apart from the routine intraoperative analgesics. Pain score will be assessed post operatively for 24 hours at regular intervals using visual analog score.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 17, 2023
• Est. primary completion date: January 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age group (18-65)

• Undergoing elective Laproscopic Cholecystectomy

• ASA status I or II

Exclusion Criteria:

• Participation in any other trial

• Known hypersensitivity to study medications

• Chronic Opioid used

• Seizure disorder

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Lidocaine IV
Bolus and infusion of lidocaine will be administered
• Ropivacaine
Bilateral TAP block will be given to these patients

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)	On arrival in PACU (0 hours)
Primary	Pain score	Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)	At 2 hours
Primary	Pain score	Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)	At 4 hours
Primary	Pain score	Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)	At 6 hours
Primary	Pain score	Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)	At 12 hours
Primary	Pain Score	Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)	At 24 hours
Secondary	Post operative nausea and vomiting	Nausea and vomiting score would be assess using Bellville scoring system (0: No nausea or vomiting, 1: nausea, 2: nausea and belching, 3: vomiting)	On arrival, At 2 hours, 4 hours, 6 hours, 12 hours and 24 hours
Secondary	Patient Satisfaction	Patient satisfaction will be assessed on Likert Scale (Completely Disagree, Disagree, Neutral, Agree, Completely Agree)	At 24 hours or discharge