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

Jawaharlal Institute of Postgraduate Medical Education & Research

Status and phase: Completed; Phase 4

Conditions: Return of Bowel Activity; Analgesic Requirement; Stress Response; Pain, Postoperative; Inadequate or Impaired Respiratory Function

Treatments: Drug: Intraperitoneal Lignocaine; Drug: Intravenous Lignocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01717222

SEC/2011/4/109

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Intraperitoneal (IP) group

Active Comparator group

Description:

Patients will receive 100 ml of 0.2% Lignocaine as intraperitoneal lignocaine irrigation in the gall bladder fossa along with a placebo of normal saline of volume equivalent to 1.5 mg/kg of intravenous lignocaine at induction and normal saline of volume equivalent to 2 mg/kg/hour of intravenous lignocaine as continuous infusion until one hour postoperatively to ensure blinding

Treatment:

Drug: Intraperitoneal Lignocaine

Intravenous (IV) group

Active Comparator group

Description:

Patients will receive 1.5mg/kg of intravenous lignocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lignocaine until one hour after surgery and 100 ml of saline intraperitoneally as placebo to ensure blinding.

Treatment:

Drug: Intravenous Lignocaine