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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002361-35 | EudraCT Number |
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This is a randomized double blinded placebo-controlled study, conducted in Lund, Sweden. Patients will be randomized in two groups, with a ratio of 1:1. The experimental arm will receive intravenous Lidocaine perioperatively, and the Control arm will receive placebo, i.e. normal Saline. Postoperative both arms will get routine pain Control with PCA, Patient Controlled Analgesia with an intravenous Oxycodone-infusion. Outcome-measures will include patients pain intensity scoring, and opioid consumption.
Patientes will be randozied in blocks of eight.
The experimental arm will receive a bolus of 1,5mg/kg before induction of anesthesia, immediately followed by an infusion of 1,5mg/kg/h until 1 hour post surgery. The placebo arm will receive the same amount of normal Saline instead. Pain intensity scoring, measured by Numerical Rating Scale, NRS, will be conducted at 1, 2, 4 hour postoperatively, and each morning and night until discharge, or for a maximum 5 Days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine arm | Experimental | The experimental arm will receive a bolus of 1,5mg/kg Lidocaine before induction of anesthesia, immediately followed by an infusion of 1,5mg/kg/h until 1 hour post surgery. |
|
| Placebo arm | Placebo Comparator | The placebo arm will receive the same amount of normal Saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Intravenous perioperative Lidocain for pain Control and improvement of postoperative recovery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption at 24 hours | Sum of opioids consumed | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption at 48 hours | Sum of opioids consumed | 48 hours postoperatively |
| Opioid consumption at 72 hours | Sum of opioids consumed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bobby Tingstedt, Prof | Lund University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital of Lund | Lund | Skåne County | 22185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23044681 | Background | Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8. | |
| 18844267 | Background | Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375. |
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After publication, for 10 years.
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Randomized double blinded placebo-controlled study
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| Normal saline | Drug | Placebo |
|
| 72 hours postoperatively |
| Opioid consumption at 96 hours | Sum of opioids consumed | 96 hours postoperatively |
| Opioid consumption at 120 hours | Sum of opioids consumed | 120 hours postoperatively |
| Postoperative pain intensity | Numerical rating scale (NRS) in rest and activity, scale 0-10, 0=no pain, 10=worst imaginable pain | Day 0-5 postoperatively, twice every day |
| Number of participants with Postoperative comlications | Comparition of Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4,5 | 30 days postoperatively |
| Level of Postoperative comlications | Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4a,4b,5, 0 beeing none and 5 beeng death. | 30 days postoperatively |
| Time to return of Bowel function | Time to first flatus and defacation | Day 0-30 postoperatively |
| Number of participants with Postoperative nausea and vomiting | Postoperative nausea and vomiting, as noted in questionary "Quality of recovery-40" | Day 1-5 postopertively |
| Level of Postoperative nausea and vomiting | Postoperative nausea and vomiting, as noted in questionary "Quality of recovery-40" | Day 1-5 postopertively |
| Days in hospital | Length of hospital stay | 0-90 days postoperatively |
| Level of MEGX concentrations | Concentration of the metabolite "MEGX" in patients blood | Twice during surgery, and once 1 hour after surgery. |
| Level of Lidocaine concentration | Concentration of Lidocaine in patients blood | Twice during surgery, and once 1 hour after surgery. |
| Mortality | death after surgery | 30 days postoperatively |
| Rating of Quality of recovery-40 | Quality of recovery questionary. | Day 1-5 postoperatively |
| Number of participant with Adverse Events | All adverse events | 0-30 days |
| Level of adverse events | All adverse events, classified according to CTCEA | 0-30 days |
| Number of participants with Chronic Postsurgical pain | Chronic Postsurgical pain, according to Brief Pain inventory- questionary | 3 months after surgery |
| Level of Chronic Postsurgical pain | Chronic Postsurgical pain, according to Brief Pain inventory- questionary | 3 months after surgery |
| 21061107 | Background | Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0. |
| 20518581 | Background | McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000. |
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| 26184397 | Background | Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2. |
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| D008107 |
| Liver Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |