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

NCT04017013 | Completed Phase 4 DMC

• 1 other identifier: SIIU 2001-15550
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative; Opioid Use

Keywords

Pain; Abdominal Surgery; Epidural analgesia; lidocaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Posoperative Pain

  2, 6, 12, 48 and 72 hours after surgery

• Posoperative opioid use

  24 hours after surgery

• Hospital Stay

  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

• Perioperative Satisfaction

  24 hours

• Toxicity by local anesthetics proportion

  24 hours after surgery

Study Arms (2)

Epidural Analgesia

ACTIVE COMPARATOR

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.

Procedure: Epidural Analgesia

Lidocaine Infussion

EXPERIMENTAL

Intravenous lidocaine

Drug: Lidocaine Infusion

Interventions

Epidural Analgesia PROCEDURE

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.

Epidural Analgesia

Lidocaine Infusion DRUG

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

Lidocaine Infussion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant woman
• Patient with contraindication for epidural analgesic techniques:
• Anticoagulated patient
• Active infection in the puncture site.
• Malformation in spinal cord.
• Sepsis without antibiotic treatment.
• Patient with contraindication for the use of intravenous lidocaine: Arrhythmias of any type not treated.
• Patient with known allergy to opioids and / or local anesthetics.
• Patient with chronic pain in previous management with strong opioids, gabapentinoids or epidural technique.
• Patient with liver failure or terminal renal failure.
• Patient who is scheduled for intubated admission to an intensive care unit after the procedure.
• Patient who refuses to participate in the study or who refuses to receive epidural analgesia.
• Patient who was technically impossible to place an epidural catheter in surgery.

Sponsors & Collaborators

• Universidad de Antioquia: lead
• IPS Universitaria-Universidad de Antioquia: collaborator

Study Sites (1)

Antioquias Univervesity Health Institution

Medellín, Antioquia, Colombia

Location

Related Publications (26)

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• 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.

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• 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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• Li M, Li L, Xu Y, Wang X. Intravenous analgesics for pain management in post- operative patients : a comparative study of their efficacy and adverse effects. 2016;15(August):1799-806.

  RESULT

• Singh AP, Singh D, Singh Y, Jain G. Postoperative analgesic efficacy of epidural tramadol as adjutant to ropivacaine in adult upper abdominal surgeries. Anesth Essays Res. 2015 Sep-Dec;9(3):369-73. doi: 10.4103/0259-1162.161805.

  PMID: 26712976 RESULT

• 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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• 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.

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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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  PMID: 25580086 RESULT

• 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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  RESULT

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  PMID: 14612482 RESULT

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  PMID: 11034732 RESULT

• Popping DM, Zahn PK, Van Aken HK, Dasch B, Boche R, Pogatzki-Zahn EM. Effectiveness and safety of postoperative pain management: a survey of 18 925 consecutive patients between 1998 and 2006 (2nd revision): a database analysis of prospectively raised data. Br J Anaesth. 2008 Dec;101(6):832-40. doi: 10.1093/bja/aen300. Epub 2008 Oct 22.

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• Terkawi AS, Tsang S, Kazemi A, Morton S, Luo R, Sanders DT, Regali LA, Columbano H, Kurtzeborn NY, Durieux ME. A Clinical Comparison of Intravenous and Epidural Local Anesthetic for Major Abdominal Surgery. Reg Anesth Pain Med. 2016 Jan-Feb;41(1):28-36. doi: 10.1097/AAP.0000000000000332.

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• Casas-Arroyave FD, Osorno-Upegui SC, Zamudio-Burbano MA. Therapeutic efficacy of intravenous lidocaine infusion compared with thoracic epidural analgesia in major abdominal surgery: a noninferiority randomised clinical trial. Br J Anaesth. 2023 Nov;131(5):947-954. doi: 10.1016/j.bja.2023.07.032. Epub 2023 Sep 26.

  PMID: 37758623 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Fabian Casas, Dr

  Univeridad de Antioquia's Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The masking process will be done as follows: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients who accept participation in the study and meet all inclusion criteria will be randomly assigned at the time of anesthetic induction. The assignment to the group of epidural analgesia vs IV lidocaine will be 1: 1 randomly using permuted blocks generated by a computer operated by an external assistant to the investigation. The size of the blocks will be variable between 4, 6, and 8, and will be kept confidential to guarantee the concealment of the groups.

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: July 12, 2019
• Study Start: March 1, 2020
• Primary Completion: September 5, 2022
• Study Completion: September 5, 2022
• Last Updated: September 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)