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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01717222
• Other study ID #: SEC/2011/4/109
• Status: Completed
• Phase: Phase 4
• First received: October 24, 2012
• Last updated: October 29, 2012
• Start date: December 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Jawaharlal Institute of Postgraduate Medical Education & Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesic Requirement
• Inadequate or Impaired Respiratory Function
• Pain, Postoperative
• Respiratory Insufficiency
• Return of Bowel Activity
• Stress Response

Intervention

Drug:
• Intraperitoneal Lignocaine
Patients will receive 100 ml of 0.2% lignocaine
• Intravenous Lignocaine
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

Locations

Country	Name	City	State
India	Department of Surgery, JIPMER	Pondicherry

Sponsors (1)

Lead Sponsor	Collaborator
Jawaharlal Institute of Postgraduate Medical Education & Research

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stress response in the form of Total Leucocyte Count (TLC) and C- reactive protein (CRP)	Blood will be analyzed for TLC and CRP preoperatively and 48 hours postoperatively to assess the stress response	Preoperatively and 48 hours Postoperatively	No
Other	Respiratory Function	Respiratory function will be assessed by measuring the peak expiratory flow rate (PEFR)at the above mentioned time frames.	Preoperatively and 48 hours Postoperatively	No
Other	Return of bowel activity	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.	upto to 48 hours	No
Primary	Post operative pain relief	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.	1 hour postoperatively	No
Secondary	Postoperative Analgesic Requirement	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.	First 24 hours in the postoperative period	No
Secondary	Postoperative pain relief	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	8 hours postoperatively	No
Secondary	Postoperative pain relief	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	24 hours postoperatively	No
Secondary	Postoperative pain relief	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	48 hours postoperatively	No

External Links

•   Pubmed site