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Completed

NCT Number: NCT05231941

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

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.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University Hospital

Karachi, Sindh, 74450, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine IV

Drug

Bolus and infusion of lidocaine will be administered

Ropivacaine

Drug

Bilateral TAP block will be given to these patients

Primary outcomes

  1. Pain score

    Time frame: On arrival in PACU (0 hours)

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

  2. Pain score

    Time frame: At 2 hours

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

  3. Pain score

    Time frame: At 4 hours

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

  4. Pain score

    Time frame: At 6 hours

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

  5. Pain score

    Time frame: At 12 hours

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

  6. Pain Score

    Time frame: At 24 hours

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

Secondary outcomes

  1. Post operative nausea and vomiting

    Time frame: On arrival, At 2 hours, 4 hours, 6 hours, 12 hours and 24 hours

    Nausea and vomiting score would be assess using Bellville scoring system (0: No nausea or vomiting, 1: nausea, 2: nausea and belching, 3: vomiting)

  2. Patient Satisfaction

    Time frame: At 24 hours or discharge

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

Sponsors and collaborators

Lead sponsor

Aga Khan University Hospital, Pakistan

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2022
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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