Postoperative Pain, Postoperative Nausea and Vomiting, Postoperative Ileus
Conditions
Keywords
perioperative lignocaine infusion, elective open abdominal surgeries, postoperative pain
Brief summary
The primary objectives of this study are to analyse the effect of perioperative systemic infusion of lignocaine on postoperative pain, postoperative nausea and vomiting and perioperative levels of inflammatory mediators in patients undergoing elective open abdominal surgeries. The secondary parameters which will be observed during the study are the time to passage of flatus and stools postoperatively.
Detailed description
Patients will be randomized into two groups- A and B, to receive an intravenous infusion of lignocaine or saline,respectively, as a bolus of 1.5mg/kg at the time of intubation followed by an infusion at a rate of 1.5mg/kg/hr continued throughout the surgery and till one hour postop. Postoperative analgesia will be provided through Patient Controlled Analgesia (PCA) pump providing morphine. Postoperative pain scores will be noted at immediate postoperative and at 6, 18, 24 hours post surgery. The number of PCA demands and cumulative morphine consumption till 24 hours post surgery will be noted. The incidence of postoperative nausea and vomiting is recorded. The time to first passage of flatus and stools postoperatively will be noted. Levels of total leukocyte count, c-reactive protein (CRP) and interleukin-6(IL-6) will be noted in preoperative, immediate post operative and 24 hours post surgery.
Interventions
Intravenous lignocaine infusion is given in intraoperative period and till one hour post surgery.
Sponsors
Jawaharlal Institute of Postgraduate Medical Education & Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients above 18 years of age * undergoing elective open abdominal surgeries * belonging to the American Society of Anaesthesiologists (ASA)status I,II,III
Exclusion criteria
* patients sensitive to lignocaine, * patients suffering from cardiovascular diseases or with preoperative changes on electrocardiogram * patients on beta blocker drugs * patients on opioid drugs for prolonged period * patients with functional bowel disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain scores using visual analogue scale | till 24 hours post surgery | Postoperative pain scores are assessed in the patients using a visual analogue scale in the first 24 hours post surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient controlled analgesia demands | Till 24 hours post surgery | The total number of times the patient presses the demand button of PCA pump are noted. |
| Total amount of morphine consumed | till 24 hours post surgery | The total morphine consumption till 24 hours post surgery is noted. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Perioperative levels of inflammatory mediators | in preoperative period, immediate post op and 24 hours post surgery | Blood samples will be collected for the analysis of total leukocyte count, C-reactive protein and Interleukin-6 levels in the preoperative period, immediate postoperative and at 24 hours post surgery. |
| time of passage of flatus and stools postoperatively | till postoperative day 7 | Postoperative bowel function recovery will be assessed by noting the time of first passage of flatus and stools postoperatively |
Countries
India
Outcome results
None listed