Lipid Emulsion for Reversal of Spinal Anesthesia in Ambulatory Surgery

NCT06988982 | Recruiting

• 1 other identifier: 1270/13-5-2025
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anaesthesia; Spinal Anesthesia Evaluation; Ambulatory Surgery

Keywords

lipid emulsion; spinal anesthesia; ambulatory surgery

Outcome Measures

Primary Outcomes (1)

• Time for complete sensory and motor regression (min)

  Time for complete sensory regression (min) (primary outcome) to be calculated from the time of ILEs administration (T0) until full sensation at S1 dermatomal level achieved Time for complete motor regression (min) (primary outcome) to be calculated from time of ILEs administration (T0) until Bromage score will be zero.

  6 hours after surgery

Secondary Outcomes (11)

• Time for two segment sensory regression (min)

  6 hours after surgery

• Time to walk (min) without or with minimal assistance

  6 hours after surgery

• Time to Void (min)

  6 hours after surgery

• Time to be home-ready (min)

  6 hours after surgery

• Time to actual hospital discharge (min)

  24 hours after surgery

Study Arms (2)

Group ILE (Intravenous lipid emulsion group)

EXPERIMENTAL

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

Drug: Intravenous Lipid Emulsion 20%

Group C (control group)

PLACEBO COMPARATOR

patients will received equal volume of normal saline at the end of surgery

Drug: Control (placebo) group

Interventions

Intravenous Lipid Emulsion 20% DRUG

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 ILE (Intravenous lipid emulsion group)

Control (placebo) group DRUG

patients will receive equal volume of normal saline at the end of surgery

Group C (control group)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Al Sharqia, 44519, Egypt

RECRUITING

Related Publications (17)

• 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.

  PMID: 23165318 BACKGROUND

• 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.

  PMID: 5322004 BACKGROUND

• 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.

  PMID: 686873 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 32633409 BACKGROUND

• 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.

  PMID: 21489160 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29492448 BACKGROUND

• 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.

  PMID: 26049929 BACKGROUND

• 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.

  PMID: 26854285 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22943123 BACKGROUND

• 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.

  PMID: 29910676 BACKGROUND

• 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.

  PMID: 33456853 BACKGROUND

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Sherif M. S. Mowafy, MD

  Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University,

  PRINCIPAL INVESTIGATOR

• Shereen E. Abd Ellatif, MD

  Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University

  STUDY DIRECTOR

Central Study Contacts

Sherif M. S. Mowafy, MD

CONTACT

+201003523374; sherifmowafy2012@gmail.com

Shereen E. Abd Ellatif, MD

CONTACT

+201007948840; shosh.again@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anesthesia, intensive care, and pain management

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: May 25, 2025
• Study Start: June 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data will be available 6 months after publication
• Access Criteria: by contacting the study director

Locations

EG (1)