Clinical trial NCT06988982: Lipid Emulsion for Reversal of Spinal Anesthesia in Ambulatory Surgery
Official title: Lipid Emulsion for Reversal of Spinal Anesthesia in Ambulatory Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Anaesthesia
Spinal Anesthesia Evaluation
Ambulatory Surgery
Keywords: lipid emulsion
spinal anesthesia
ambulatory surgery
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-05-25
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Ambulatory surgery places high demands on anesthetic technique. rapid onset and offset of anesthesia, rapid recovery of protective reflexes, mobility and micturition, are required. Since the inception of ambulatory surgery, the favored anesthetic technique has been general anesthesia with short-acting drugs. Concerns about the time to perform spinal anesthesia and the risks of prolonged motor block and urinary retention have limited its use.

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.

Detailed description: An increasing number of ambulatory surgical patients is challenging the currently used anaesthesia methods, reliable surgical anaesthesia should be quick, with rapid recovery and minimal side effects. Spinal anaesthesia (SA) is an easy and reliable technique that has grown in popularity for inpatient surgery, but its use in ambulatory surgery has been limited due to several factors including the prolonged neurological block with long-acting local anaesthetics (LA), delayed ambulation, risk of urinary retention and pain after block regression therefore delaying patient discharge. On the other hand, general anaesthesia with short-acting drugs grants rapid recovery enabling the early discharge. While recovery after spinal anaesthesia has been recently improved by lowering the dose of the commonly used long-acting local anaesthetics such as bupivacaine, discharge times are still prolonged compared to general anaesthesia.

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.

Eligibility criteria: Inclusion Criteria:

* Patient acceptance.
* 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:

* History of allergy to the LA agents used in this study,
* Skin lesion at needle insertion site,
* Those with bleeding disorders, sepsis, liver disease and psychiatric disorders
* History of cognitive dysfunction or mental illness

Primary outcomes:
measure: Time for complete sensory and motor regression (min)
timeFrame: 6 hours after surgery
Secondary outcomes:
measure: Time for two segment sensory regression (min)
timeFrame: 6 hours after surgery
measure: Time to walk (min) without or with minimal assistance
timeFrame: 6 hours after surgery
measure: Time to Void (min)
timeFrame: 6 hours after surgery
measure: Time to be home-ready (min)
timeFrame: 6 hours after surgery
measure: Time to actual hospital discharge (min)
timeFrame: 24 hours after surgery
measure: Heart rate (HR), and arterial blood pressure (MAP)
timeFrame: 6 hours after surgery
measure: Numerical rating scale (NRS)
timeFrame: 24 hours after surgery
measure: Time to first rescue analgesia (min)
timeFrame: 24 hours after surgery
measure: Total dose of rescue analgesia (diclofenac sodium)
timeFrame: 24 hours after surgery
measure: Postoperative Complications.
timeFrame: 2 weeks after surgery
measure: Patient satisfaction
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
state: Al Sharqia
Study officials:
affiliation: Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University,
name: Sherif M. S. Mowafy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University
name: Shereen E. Abd Ellatif, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.