Pain, Postoperative, Analgesic Requirement, Stress Response, Return of Bowel Activity, Inadequate or Impaired Respiratory Function
Conditions
Keywords
Lignocaine, Laparoscopic cholecystectomy, Pain relief
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.
Interventions
DRUGIntraperitoneal Lignocaine
Patients will receive 100 ml of 0.2% 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
Sponsors
Jawaharlal Institute of Postgraduate Medical Education & Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative pain relief | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Analgesic Requirement | 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. |
| Postoperative pain relief | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stress response in the form of Total Leucocyte Count (TLC) and C- reactive protein (CRP) | Preoperatively and 48 hours Postoperatively | Blood will be analyzed for TLC and CRP preoperatively and 48 hours postoperatively to assess the stress response |
| Respiratory Function | Preoperatively and 48 hours Postoperatively | Respiratory function will be assessed by measuring the peak expiratory flow rate (PEFR)at the above mentioned time frames. |
| Return of bowel activity | 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. |
Countries
India
Outcome results
None listed