Lipid Emulsion for Reversal of Spinal Anesthesia in Ambulatory Surgery
NCT ID: NCT06988982
Last Updated: 2025-05-25
Study Results
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Basic Information
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RECRUITING
NA
42 participants
INTERVENTIONAL
2025-06-01
2026-01-01
Brief Summary
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Alpha-blockers, lavage fluids for epidural space, insulin, and intravenous lipid emulsions, are still being discussed to shorten and reverse adverse effect of different LAs used for spinal anaesthesia, hence we will evaluate the effectiveness of intravenous lipid emulsion for reversing the neural blockade of spinal anaesthesia in patients undergoing ambulatory surgery.
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Detailed Description
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Intravenous lipid emulsions (ILEs) were originally developed as a part of parenteral nutrition for critically ill patients, dating back to the 1960s. Over the last ten years, there has been rising interest in ILEs in clinical toxicology beyond its established role in the treatment of acute intoxication with local anaesthetics (LAST). The use of ILEs for the treatment of lipophilic drug toxicity is increasing nowadays with several studies reported alleviation of intractable cardiovascular collapse induced by toxic doses of these non-local anaesthetic drugs including calcium channel blockers (verapamil), tricyclic antidepressants (amitriptyline) and beta-blockers. In addition, Complications following intrathecal administration of bupivacaine have been reported to be successfully managed with intravenous administration of lipid emulsion.
While the precise mechanism by which ILEs exerts its effect remains unknown, the leading theory is that the ILEs intravascular action entails creating a concentration gradient which favours LA redistribution to the extracellular space. Lipid vesicles then encapsulate LA creating lipid sinks and the formation of this "trap" removes the toxins from the various tissues and organs, reducing their bioavailability and the sequestration mechanism where LA is rapidly redistributed by "lipid shuttles" to sites of metabolism (liver), storage (adipose tissue) or elimination (kidney). Alternative theories include reduced binding of local anaesthetics to sodium transport channels, direct promotion of sodium channel function recovery, and replenishing ATP stores from increased uptake of fatty acids by mitochondria.
Considering the few published reports supporting the effectiveness of ILEs in reversing the primary nervous system effects of regional anaesthesia such as total or high spinal anaesthesia, prolonged neural blockade, and reverse phrenic nerve palsy secondary to a brachial plexus block with the well-known favourable safety profile of ILEs. We hypothesized that ILEs could be an attractive effective option to reverse the sensory and motor actions of intrathecal bupivacaine thus accelerating the neurological recovery after spinal anaesthesia which could avert the delayed hospital discharge and facilitate the use of SA for ambulatory surgeries.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Group ILE (Intravenous lipid emulsion group)
patients will receive 1.5 ml/kg bolus of intravenous lipid emulsion 20 % followed by 0.25 ml/kg/hour infusion over 30 minutes at the end of surgery
Intravenous Lipid Emulsion 20%
patients will receive 1.5 ml/kg bolus of intravenous lipid emulsion 20 % followed by 0.25 ml/kg/hr infusion over 30 minutes at the end of surgery
Group C (control group)
patients will received equal volume of normal saline at the end of surgery
Control (placebo) group
patients will receive equal volume of normal saline at the end of surgery
Interventions
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Intravenous Lipid Emulsion 20%
patients will receive 1.5 ml/kg bolus of intravenous lipid emulsion 20 % followed by 0.25 ml/kg/hr infusion over 30 minutes at the end of surgery
Control (placebo) group
patients will receive equal volume of normal saline at the end of surgery
Eligibility Criteria
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Inclusion Criteria
* Cooperative patient
* Age 21-70 years old.
* BMI ≤ 35 kg/m2
* ASA I - II.
* Elective ambulatory surgery under spinal anesthesia (general surgery, urology, gynecology, orthopedic surgery).
Exclusion Criteria
* Skin lesion at needle insertion site,
* Those with bleeding disorders, sepsis, liver disease and psychiatric disorders
* History of cognitive dysfunction or mental illness
21 Years
70 Years
ALL
No
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Sherif M. S. Mowafy
Associate professor of anesthesia, intensive care, and pain management
Principal Investigators
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Sherif M. S. Mowafy, MD
Role: PRINCIPAL_INVESTIGATOR
Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University,
Shereen E. Abd Ellatif, MD
Role: STUDY_DIRECTOR
Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University
Locations
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Zagazig University Hospitals
Zagazig, Al Sharqia, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Tampakis K, Vogiatzakis N, Kontogiannis C, Spartalis M, Ntalianis A, Spartalis E, Siafaka I, Iacovidou N, Chalkias A, Xanthos T. Intravenous lipid emulsion as an antidote in clinical toxicology: a systematic review. Eur Rev Med Pharmacol Sci. 2020 Jun;24(12):7138-7148. doi: 10.26355/eurrev_202006_21708.
Cave G, Harvey M, Graudins A. Intravenous lipid emulsion as antidote: a summary of published human experience. Emerg Med Australas. 2011 Apr;23(2):123-41. doi: 10.1111/j.1742-6723.2011.01398.x. Epub 2011 Apr 7.
11. Hadbi M, Benalakma D, Berbiche R, et al. Effect of lipid infusion on the reversal of atypically prolonged duration and high spinal anesthesia. About two cases. J Clin Res Anesthesiol. 2021; 4: 1-4.
10. Hadbi M, Benalakma D, Berbiche R, et al. Abnormal Prolonged Duration of Spinal Anesthesia in Patient with Multiple Sclerosis. J Anesth Clin Res. 2021; 12: 984.
Palumbo P, Tellan G, Perotti B, Pacile MA, Vietri F, Illuminati G. Modified PADSS (Post Anaesthetic Discharge Scoring System) for monitoring outpatients discharge. Ann Ital Chir. 2013 Nov-Dec;84(6):661-5.
Bromage PR. A comparison of the hydrochloride and carbon dioxide salts of lidocaine and prilocaine in epidural analgesia. Acta Anaesthesiol Scand Suppl. 1965;16:55-69. doi: 10.1111/j.1399-6576.1965.tb00523.x. No abstract available.
9. Joseph Eldor, Pham V, Tran TP, et al. Local Anesthesia Reversal LAR of Total Spinal Anesthesia TSA by Lipofundin Lipid Emulsion. Jor Health Sci Development. 2018; 1: 67-72.
8. Seglenieks R, Chowdhury A. Use of Lipid Emulsion to Reverse the Effects of Regional Anesthesia: A Novel Indication. Translational Perioperative and Pain Medicine. 2023; 10 (1):512-514. DOI 10.31480/2330-4871/171.
Hoshino R, Kamiya Y, Fujii Y, Tsubokawa T. Lipid emulsion injection-induced reversal of cardiac toxicity and acceleration of emergence from general anesthesia after scalp infiltration of a local anesthetic: a case report. JA Clin Rep. 2017;3(1):9. doi: 10.1186/s40981-017-0077-6. Epub 2017 Feb 10.
Muller SH, Diaz JH, Kaye AD. Clinical applications of intravenous lipid emulsion therapy. J Anesth. 2015 Dec;29(6):920-6. doi: 10.1007/s00540-015-2036-6. Epub 2015 Jun 7.
Picard J, Meek T. Lipid emulsion for intoxication by local anaesthetic: sunken sink? Anaesthesia. 2016 Aug;71(8):879-82. doi: 10.1111/anae.13395. Epub 2016 Feb 8. No abstract available.
Afolayan JM, Olajumoke TO, Olaogun J, Kadiri I. Reversal of spinal anaesthesia and prevention of post operative complications using intralipid emulsion. J Clin Images Med Case Rep. 2024; 5(2): 2880.
Waring WS. Intravenous lipid administration for drug-induced toxicity: a critical review of the existing data. Expert Rev Clin Pharmacol. 2012 Jul;5(4):437-44. doi: 10.1586/ecp.12.27.
Ok SH, Hong JM, Lee SH, Sohn JT. Lipid Emulsion for Treating Local Anesthetic Systemic Toxicity. Int J Med Sci. 2018 May 14;15(7):713-722. doi: 10.7150/ijms.22643. eCollection 2018.
Rattenberry W, Hertling A, Erskine R. Spinal anaesthesia for ambulatory surgery. BJA Educ. 2019 Oct;19(10):321-328. doi: 10.1016/j.bjae.2019.06.001. Epub 2019 Aug 13. No abstract available.
Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. Studies with pain rating scales. Ann Rheum Dis. 1978 Aug;37(4):378-81. doi: 10.1136/ard.37.4.378.
14. Kumar KS, Talawar P, Gupta B, et al. OP020 Efficacy of 20% intravenous lipid emulsion as a reversal agent of spinal anaesthesia: a double blinded randomized controlled trial. Regional Anesthesia & Pain Medicine 2023;48:A12.
Other Identifiers
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1270/13-5-2025
Identifier Type: -
Identifier Source: org_study_id
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