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

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Lidocaine IV
Ropivacaine
Sponsored by
Aga Khan University Hospital, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aga Khan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Lidocaine Group

TAP group

Control group

Arm Description

After induction of anaesthesia, a bolus of 2mg/kg intravenous lidocaine will be given followed by Lidocaine infusion at the rate of 1.5 mg/kg/hour which will be stopped at the end of surgery.

After completion of procedure and before extubation, bilateral ultrasound guided subcoastal transversus abdominis plane (TAP) block will be performed by the primary anaesthetist. After taking aseptic measures, with patient in supine position a high frequency (6-13 MHz) linear ultrasound probe will be placed obliquely just inferior to the costal margin over the anterior abdominal wall. With the help of a 21G or 22G, 100 mm needle, 20 ml of 0.375% Ropivacaine will be injected between rectus sheath and fascia of transversus abdominis muscle, bilaterally.

No additional intervention will be given to this group

Outcomes

Primary Outcome Measures

Pain score
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Pain score
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Pain score
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Pain score
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Pain score
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Pain Score
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)

Secondary Outcome Measures

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)
Patient Satisfaction
Patient satisfaction will be assessed on Likert Scale (Completely Disagree, Disagree, Neutral, Agree, Completely Agree)

Full Information

First Posted
January 19, 2022
Last Updated
February 9, 2022
Sponsor
Aga Khan University Hospital, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT05231941
Brief Title
Comparison of Intraoperative Intravenous Lidocaine Infusion and Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia Following Laproscopic Cholecystectomy
Official Title
Comparison of Intraoperative Intravenous Lidocaine Infusion and Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia Following Laproscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
January 17, 2023 (Anticipated)
Study Completion Date
January 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University Hospital, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine Group
Arm Type
Experimental
Arm Description
After induction of anaesthesia, a bolus of 2mg/kg intravenous lidocaine will be given followed by Lidocaine infusion at the rate of 1.5 mg/kg/hour which will be stopped at the end of surgery.
Arm Title
TAP group
Arm Type
Experimental
Arm Description
After completion of procedure and before extubation, bilateral ultrasound guided subcoastal transversus abdominis plane (TAP) block will be performed by the primary anaesthetist. After taking aseptic measures, with patient in supine position a high frequency (6-13 MHz) linear ultrasound probe will be placed obliquely just inferior to the costal margin over the anterior abdominal wall. With the help of a 21G or 22G, 100 mm needle, 20 ml of 0.375% Ropivacaine will be injected between rectus sheath and fascia of transversus abdominis muscle, bilaterally.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No additional intervention will be given to this group
Intervention Type
Drug
Intervention Name(s)
Lidocaine IV
Intervention Description
Bolus and infusion of lidocaine will be administered
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Bilateral TAP block will be given to these patients
Primary Outcome Measure Information:
Title
Pain score
Description
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Time Frame
On arrival in PACU (0 hours)
Title
Pain score
Description
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Time Frame
At 2 hours
Title
Pain score
Description
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Time Frame
At 4 hours
Title
Pain score
Description
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Time Frame
At 6 hours
Title
Pain score
Description
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Time Frame
At 12 hours
Title
Pain Score
Description
Pain score will be assessed using visual analog scoring system (0: No pain and 10: Worst Imaginable Pain)
Time Frame
At 24 hours
Secondary Outcome Measure Information:
Title
Post operative nausea and vomiting
Description
Nausea and vomiting score would be assess using Bellville scoring system (0: No nausea or vomiting, 1: nausea, 2: nausea and belching, 3: vomiting)
Time Frame
On arrival, At 2 hours, 4 hours, 6 hours, 12 hours and 24 hours
Title
Patient Satisfaction
Description
Patient satisfaction will be assessed on Likert Scale (Completely Disagree, Disagree, Neutral, Agree, Completely Agree)
Time Frame
At 24 hours or discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haris Sheikh, MBBS
Phone
923452432387
Email
haris.sheikh@aku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hameed Ullah, FCPS
Phone
923332313134
Email
hameed.ullah@aku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haris Sheikh, MBBS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sind
ZIP/Postal Code
74450
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nausheen Abbas
Phone
922134862899
Email
nausheen.abbas@aku.edu

12. IPD Sharing Statement

Learn more about this trial

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

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