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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017013
• Other study ID #: SIIU 2001-15550
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: September 5, 2022

Study information

• Verified date: May 2022
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Major abdominal surgery continues is one of the most performed surgical procedures in the world, both electively and urgently. One of the main problems of this type of intervention is postoperative pain. it is shown that it increases health costs related to longer recovery times, longer hospital stay and related complications such as the increased risk of presenting chronic POP pain, which it has been estimated up to 20%, much higher if the surgery involves surgery in the gastrointestinal system.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: September 5, 2022
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 years.

• 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:

• Pregnant woman

• 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.

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative

Intervention

Procedure:
• 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.

Drug:
• Lidocaine Infusion
2% Lidocaine IV without epinephrine: 1 mg/kg/ hour for up to 24 hours, started immediately after anesthetic induction.

Locations

Country	Name	City	State
Colombia	Antioquias Univervesity Health Institution	Medellin	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Antioquia	IPS Universitaria-Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

References & Publications (25)

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Couceiro TC, Valença 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. English, Portuguese. — View Citation

Jørgensen H, Wetterslev J, Møiniche S, Dahl JB. Epidural local anaesthetics versus opioid-based analgesic regimens on postoperative gastrointestinal paralysis, PONV and pain after abdominal surgery. Cochrane Database Syst Rev. 2000;(4):CD001893. Review. U — View Citation

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Khan JS, Yousuf M, Victor JC, Sharma A, Siddiqui N. An estimation for an appropriate end time for an intraoperative intravenous lidocaine infusion in bowel surgery: a comparative meta-analysis. J Clin Anesth. 2016 Feb;28:95-104. doi: 10.1016/j.jclinane.20 — View Citation

Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. d — View Citation

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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. — View Citation

Wongyingsinn M, Baldini G, Charlebois P, Liberman S, Stein B, Carli F. Intravenous lidocaine versus thoracic epidural analgesia: a randomized controlled trial in patients undergoing laparoscopic colorectal surgery using an enhanced recovery program. Reg A — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posoperative Pain	Numerical Rating Scale (NRS) for pain. The NRS for pain is a unidimensional measure of pain intensity in adults.The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable").	24 hours after surgery
Secondary	Posoperative Pain	Numerical Rating Scale (NRS) for pain. The NRS for pain is a unidimensional measure of pain intensity in adults.The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable").	2, 6, 12, 48 and 72 hours after surgery
Secondary	Posoperative opioid use	mg of morphine	24 hours after surgery
Secondary	Hospital Stay	days	From date of randomization until the date day of discharge or date of death from any cause, whichever came first, assessed up to 100 months
Secondary	Perioperative Satisfaction	Evaluation du Vecu de l'Anesthesie Generale (EVAN G scale). The EVAN questionnaire is composed of 6 dimensions (attention, privacy, information, pain, discomfort and waiting times), which in turn consist of 26 items. Each item is evaluated with in an ordinal scale. The minimum value is 1, meaning the worst value for the item and the maximum value is 5, meaning the better value for the item.	24 hours
Secondary	Toxicity by local anesthetics proportion	Proportion of patients presenting signs of toxicity by local anesthetics.; Metal taste; Tinnitus; Hypotension (SBP less than 80 mmHg); Tachycardia (FC greater than 130); Bradycardia (FC less than 40); Alterations of the mental state. It is positive for this outcome with 3 signs or if patient presents seizures or coma without a non-surgical or medical cause associated with the patient's clinical status.	24 hours after surgery
Secondary	Posoperative nausea and vomiting	Proportion of patients with at least one episode of nausea or vomiting in the postoperative period.	24 hours after surgey