Clinical trial NCT01717222: Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy
Official title: Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Analgesic Requirement
Stress Response
Return of Bowel Activity
Inadequate or Impaired Respiratory Function
Keywords: Lignocaine
Laparoscopic cholecystectomy
Pain relief
Lead sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research
Sponsor class: OTHER_GOV
First posted: 2012-10-30
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Post operative pain relief
timeFrame: 1 hour postoperatively
Secondary outcomes:
measure: Postoperative Analgesic Requirement
timeFrame: First 24 hours in the postoperative period
measure: Postoperative pain relief
timeFrame: 8 hours postoperatively
measure: Postoperative pain relief
timeFrame: 24 hours postoperatively
measure: Postoperative pain relief
timeFrame: 48 hours postoperatively
Other outcomes:
measure: Stress response in the form of Total Leucocyte Count (TLC) and C- reactive protein (CRP)
timeFrame: Preoperatively and 48 hours Postoperatively
measure: Respiratory Function
timeFrame: Preoperatively and 48 hours Postoperatively
measure: Return of bowel activity
timeFrame: upto to 48 hours
Locations:
city: Pondicherry
country: India
facility: Department of Surgery, JIPMER
Study officials:
affiliation: Jawaharlal Institute of Postgraduate Medical Education & Research
name: Dr. Sarath Chandra Sistla, M.S.,
role: STUDY_CHAIR
References:
citation: Jabbour-Khoury SI, Dabbous AS, Gerges FJ, Azar MS, Ayoub CM, Khoury GS. Intraperitoneal and intravenous routes for pain relief in laparoscopic cholecystectomy. JSLS. 2005 Jul-Sep;9(3):316-21.