Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial
NCT ID: NCT04017013
Last Updated: 2022-09-26
Study Results
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Basic Information
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COMPLETED
PHASE4
210 participants
INTERVENTIONAL
2020-03-01
2022-09-05
Brief Summary
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The goal of analgesia in the postoperative setting is precisely to provide comfort to patients, minimize adverse effects and complications arising from the procedure.
The epidural analgesic technique (has been proposed as an analgesic management standard, since multiple studies have shown that it reduces opioid consumption, improves recovery and is a useful strategy for pain control. However, it is an invasive technique, with risk of complications such as hematomas and epidural abscesses, and it may be difficult to perform.
Currently it has been shown in multiple studies that the intravenous infusion of a local anesthetic, such as lidocaine, in this type of surgical scenarios can reduce the intensity of pain, opioid consumption, hospital stay and ileus with few adverse effects. In addition, these studies propose that, being a less invasive technique, it could be easier to implement and even be safer than the epidural technique.
The main hypothesis of this study is precisely that the infusion of lidocaine may be non-inferior to epidural analgesia in the analgesic management of patients undergoing major abdominal surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Masking of the data collection and analysis staff: The investigative staff who performs the data collection and who evaluates the outcomes after the anesthetic act, will not have information about the intervention received by the patient. Those who participate in the data analysis phase will also be blind to the intervention.
For practical and ethical point of view, it is not possible to mask the doctors who perform the intervention and neither the patients. A "SHAM" or simulated intervention is not possible given that this would require an unnecessary invasive procedure that would not be used, which would make it ethically questionable.
Study Groups
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Epidural Analgesia
The placement of the thoracic epidural catheter will be located depending on surgical incision as follows:
* Surgery of the upper abdomen: T7-T8.
* Surgery of lower abdomen: T8-T9. The epidural catheter placement technique will be determined by the treating anesthesiologist. However, once the epidural space is located and the respective catheter is inserted, the correct location of the catheter should be tested with lidocaine at 2% CE 5 cc and a sensitivity test with temperature should be performed on the target dermatomes. A negative test for an adequate location of the catheter indicates that the procedure should be repeated until the epidural space is correctly located. Once this is achieved, the catheter will be left 4 cm away from the skin. The catheter will be fixed according to the institutional protocol.
Epidural Analgesia
The epidural infusion will be as follows:
* Isobaric Bupivacaine 0.5% 40 cc
* Morphine 4 mg (1 ampoule up to 10 cc and 4 cc of the mixture will be applied)
* Saline solution 0.9% 156 cc.
* Total Volume: 200 cc.
This mixture will be prepared by a nurse outside the research group outside the operating room once indicated.
The infusion will be scheduled at 7 cc / hour per continuous infusion set and will be connected to the epidural catheter after its placement.
Lidocaine Infussion
Intravenous lidocaine
Lidocaine Infusion
2% Lidocaine IV without epinephrine: 1 mg/kg/ hour for up to 24 hours, started immediately after anesthetic induction.
Interventions
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Epidural Analgesia
The epidural infusion will be as follows:
* Isobaric Bupivacaine 0.5% 40 cc
* Morphine 4 mg (1 ampoule up to 10 cc and 4 cc of the mixture will be applied)
* Saline solution 0.9% 156 cc.
* Total Volume: 200 cc.
This mixture will be prepared by a nurse outside the research group outside the operating room once indicated.
The infusion will be scheduled at 7 cc / hour per continuous infusion set and will be connected to the epidural catheter after its placement.
Lidocaine Infusion
2% Lidocaine IV without epinephrine: 1 mg/kg/ hour for up to 24 hours, started immediately after anesthetic induction.
Eligibility Criteria
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Inclusion Criteria
* Elective major open intra-abdominal surgery:
* Cholecystectomy.
* Total or subtotal gastrectomy.
* Colectomy or Hemicolectomy.
* Pancreatoduodenectomy.
* Hepatectomy 1 or 2 segments.
* Exploration and / or reconstruction of the bile duct.
* Abdominal demolition.
* Sigmoidectomy.
* Patient classified as ASA (American Association of Anesthesiology) 1, 2 or 3.
Exclusion Criteria
* Patient with contraindication for epidural analgesic techniques:
1. Anticoagulated patient
2. Active infection in the puncture site.
3. Malformation in spinal cord.
4. Sepsis without antibiotic treatment.
5. Patient with contraindication for the use of intravenous lidocaine: Arrhythmias of any type not treated.
6. Patient with known allergy to opioids and / or local anesthetics.
7. Patient with chronic pain in previous management with strong opioids, gabapentinoids or epidural technique.
8. Patient with liver failure or terminal renal failure.
9. Patient who is scheduled for intubated admission to an intensive care unit after the procedure.
10. Patient who refuses to participate in the study or who refuses to receive epidural analgesia.
11. Patient who was technically impossible to place an epidural catheter in surgery.
18 Years
ALL
Yes
Sponsors
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IPS Universitaria-Universidad de Antioquia
UNKNOWN
Universidad de Antioquia
OTHER
Responsible Party
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Principal Investigators
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Fabian Casas, Dr
Role: PRINCIPAL_INVESTIGATOR
Univeridad de Antioquia's Professor
Locations
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Antioquias Univervesity Health Institution
Medellín, Antioquia, Colombia
Countries
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References
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Shipton EA. The transition from acute to chronic post surgical pain. Anaesth Intensive Care. 2011 Sep;39(5):824-36. doi: 10.1177/0310057X1103900506.
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.
Couceiro TC, Valenca MM, Lima LC, de Menezes TC, Raposo MC. Prevalence and influence of gender, age, and type of surgery on postoperative pain. Rev Bras Anestesiol. 2009 May-Jun;59(3):314-20. doi: 10.1590/s0034-70942009000300006. English, Portuguese.
Singh PK, Saikia P, Lahakar M. Prevalence of acute post-operative pain in patients in adult age-group undergoing inpatient abdominal surgery and correlation of intensity of pain and satisfaction with analgesic management: A cross-sectional single institute-based study. Indian J Anaesth. 2016 Oct;60(10):737-743. doi: 10.4103/0019-5049.191686.
Bouman EA, Theunissen M, Bons SA, van Mook WN, Gramke HF, van Kleef M, Marcus MA. Reduced incidence of chronic postsurgical pain after epidural analgesia for abdominal surgery. Pain Pract. 2014 Feb;14(2):E76-84. doi: 10.1111/papr.12091. Epub 2013 Jun 12.
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Nworah U. From documentation to the problem: controlling postoperative pain. Nurs Forum. 2012 Apr-Jun;47(2):91-9. doi: 10.1111/j.1744-6198.2012.00262.x.
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Ventham NT, Kennedy ED, Brady RR, Paterson HM, Speake D, Foo I, Fearon KC. Efficacy of Intravenous Lidocaine for Postoperative Analgesia Following Laparoscopic Surgery: A Meta-Analysis. World J Surg. 2015 Sep;39(9):2220-34. doi: 10.1007/s00268-015-3105-6.
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Ventham NT, Hughes M, O'Neill S, Johns N, Brady RR, Wigmore SJ. Systematic review and meta-analysis of continuous local anaesthetic wound infiltration versus epidural analgesia for postoperative pain following abdominal surgery. Br J Surg. 2013 Sep;100(10):1280-9. doi: 10.1002/bjs.9204.
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Other Identifiers
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SIIU 2001-15550
Identifier Type: -
Identifier Source: org_study_id
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