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NCT Number: NCT01717222

Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and intravenous administration of lignocaine has been used. But it is not clear from the existing literature which form of administration is more effective for pain relief. Hence this study has been undertaken with the following hypothesis : Intravenous lignocaine is superior to intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response in laparoscopic cholecystectomy.

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Key information

Conditions

Pain, Postoperative Analgesic Requirement Fractures, Bone Fractures, Stress Inadequate or Impaired Respiratory Function Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Return of Bowel Activity Signs and Symptoms Stress Response Wounds and Injuries

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Surgery, JIPMER

Puducherry, 605006, India

About this study

Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and intravenous administration of lignocaine has been used. But it is not clear from the existing literature which form of administration is more effective for pain relief. Hence this study has been undertaken with the following hypothesis : Intravenous lignocaine is superior to intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response in laparoscopic cholecystectomy.

In this study the effect of intraperitoneal and intravenous lignocaine will be assessed based on the postoperative pain scores, total analgesic requirement, stress response in the form of total leukocyte count, c-reactive protein levels,return of bowel activity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients planned for elective laparoscopic cholecystectomy in the age group of 20 -60 years belonging to American society of anesthesiologists (ASA)score I-II

Exclusion criteria

  • Chronic pain diseases other than gall stone disease.
  • Use of opioids, steroids, Non steroidal anti inflammatory drugs or alcohol.
  • Allergy and contraindication to Lignocaine.
  • Conversion to open cholecystectomy.
  • Patients who do not comprehend Visual analogue scale (VAS) / patient controlled analgesia (PCA).

Treatment and study plan

Intraperitoneal Lignocaine

Drug

Patients will receive 100 ml of 0.2% lignocaine

Other names: IP Lignocaine

Intravenous lignocaine

Drug

Intravenous group patients will receive 1.5mg/kg of lignocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion until one hour after surgery

Other names: IV lignocaine

Primary outcomes

  1. Post operative pain relief

    Time frame: 1 hour postoperatively

    Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 1 hour postoperatively.

Secondary outcomes

  1. Postoperative Analgesic Requirement

    Time frame: First 24 hours in the postoperative period

    Patients will get analgesia through patient controlled analgesia pump (PCA). This pump delivers Morphine for pain relief. This will be delivered at 1 mg/ml bolus dose with a lock out period of 15 minutes without any background infusion of the drug. The total requirement over a period of 24 hours will be noted. Also the time taken for the patient to take the first analgesic dose will be recorded. The total demands and the number of good demands in the PCA pump will also be recorded.

  2. Postoperative pain relief

    Time frame: 8 hours postoperatively

    Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 8 hours postoperatively

  3. Postoperative pain relief

    Time frame: 24 hours postoperatively

    Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 24 hours postoperatively

  4. Postoperative pain relief

    Time frame: 48 hours postoperatively

    Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 48 hours postoperatively

Other outcomes

  1. Stress response in the form of Total Leucocyte Count (TLC) and C- reactive protein (CRP)

    Time frame: Preoperatively and 48 hours Postoperatively

    Blood will be analyzed for TLC and CRP preoperatively and 48 hours postoperatively to assess the stress response

  2. Respiratory Function

    Time frame: Preoperatively and 48 hours Postoperatively

    Respiratory function will be assessed by measuring the peak expiratory flow rate (PEFR)at the above mentioned time frames.

  3. Return of bowel activity

    Time frame: upto to 48 hours

    This will be assessed by asking the time at which the patient perceives the first bowel movement and also the time for passage of flatus post surgery.

Sponsors and collaborators

Lead sponsor

Jawaharlal Institute of Postgraduate Medical Education & Research

Other Gov

Registry information

Official study title

Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy - A Randomized Clinical Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 30, 2012
Registry last updated
Oct 30, 2012

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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