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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous lignocaine | Active Comparator | Intravenous lignocaine will be given as a bolus of 1.5mg/kg at the time of intubation followed by an infusion at a rate of 1.5mg/kg/hr throughout surgery and till one hour post surgery. |
|
| normal saline | Placebo Comparator | Normal saline will be given as a bolus at the time of intubation and saline infusion given to patients in the control group during the surgery and till one hour post surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous lignocaine | Drug | Intravenous lignocaine infusion is given in intraoperative period and till one hour post surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain scores using visual analogue scale | Postoperative pain scores are assessed in the patients using a visual analogue scale in the first 24 hours post surgery | till 24 hours post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patient controlled analgesia demands | The total number of times the patient presses the demand button of PCA pump are noted. | Till 24 hours post surgery |
| Total amount of morphine consumed |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative levels of inflammatory mediators | 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. | in preoperative period, immediate post op and 24 hours post surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| parnandi sridhar, MBBS | Junior resident,JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY, INDIA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jawaharlal Institute of Postgraduate Medical Education and Research | Puducherry | Puducherry | 605006 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3898920 | Background | Cassuto J, Wallin G, Hogstrom S, Faxen A, Rimback G. Inhibition of postoperative pain by continuous low-dose intravenous infusion of lidocaine. Anesth Analg. 1985 Oct;64(10):971-4. | |
| 9459225 | Background | Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
The total morphine consumption till 24 hours post surgery is noted.
| till 24 hours post surgery |
| time of passage of flatus and stools postoperatively |
Postoperative bowel function recovery will be assessed by noting the time of first passage of flatus and stools postoperatively |
| till postoperative day 7 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| Aniline Compounds |
| D000588 | Amines |