Spinal AnaesthesiaNCT06988982
Lipid Emulsion for Reversal of Spinal Anesthesia in Ambulatory Surgery
A study testing Intravenous Lipid Emulsion 20% in people with Spinal Anaesthesia and Spinal Anesthesia Evaluation, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Spinal Anaesthesia, Spinal Anesthesia Evaluation, Ambulatory Surgery
- What is being tested?
- Intravenous Lipid Emulsion 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lipid Emulsion for Reversal of Spinal Anesthesia in Ambulatory Surgery: A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Intravenous Lipid Emulsion 20%, Control (placebo) group
- Keywords
- lipid emulsion, spinal anesthesia, ambulatory surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Control (placebo) groupDrug
patients will receive equal volume of normal saline at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Intravenous Lipid Emulsion 20% |
| Group C (control group) | Placebo comparator | patients will received equal volume of normal saline at the end of surgery Receives: Drug: Control (placebo) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours after surgery
Secondary outcomes (11)
Time for two segment sensory regression (min)
the time for regression by two dermatomes compared with the dermatomal level assessed at finishing ILEs infusion (T0)
Measured: 6 hours after surgery
Time to walk (min) without or with minimal assistance
the time from the ILE administration time (T0) till the patients first stand and walk.
Measured: 6 hours after surgery
Time to Void (min)
the time from the ILE administration time (T0) till the patients first urinate.
Measured: 6 hours after surgery
Time to be home-ready (min)
the time from the ILE administration time (T0) till the patients are ready for home discharge as defined by the modified post anaesthesia discharge scoring system.
Measured: 6 hours after surgery
Time to actual hospital discharge (min)
the period from the end of the surgery till the patients actually leaves the hospital.
Measured: 24 hours after surgery
Heart rate (HR), and arterial blood pressure (MAP)
Heart rate (HR), and arterial blood pressure (MAP), will be recorded immediately before and after the ILEs administration, at PACU admission and then every 15 min till the PACU discharge.
Measured: 6 hours after surgery
Numerical rating scale (NRS)
Numerical rating scale (NRS) will be postoperatively assessed and recorded at PACU admission, PACU discharge to phase II recovery, in phase II recovery room, before actual hospital discharge and at 24 h.
Measured: 24 hours after surgery
Time to first rescue analgesia (min)
the time between ILE administration (T0) to the time patients make their first request for pain relief and NRS ≥ 3.
Measured: 24 hours after surgery
Total dose of rescue analgesia (diclofenac sodium)
Total dose of rescue analgesia (diclofenac sodium), that will be consumed in the first 24 hours postoperatively.
Measured: 24 hours after surgery
Postoperative Complications.
Postoperative complications will be evaluated including nausea and vomiting, the use of antiemetics, inability to void within 4h after surgery, post-dural puncture headache, transient neurological symptoms (TNS) and lipid emulsions related adverse effects such as hypotension, bradycardia, fever, dyspnea, allergic reaction, increased risk of infection, and fat overload syndrome.
The day after surgery and for one week, all patients will be contacted by telephone and asked about pain and analgesic use, low back pain, headache and transient neurological symptoms. One and two weeks after surgery, patients will be evaluated by the surgical team and the existence of any complications will be recorded.
Measured: 2 weeks after surgery
Patient satisfaction
Patient satisfaction using a 3-point Likert scale (3=satisfied, 2= neutral, 1=dissatisfied).
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jun 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Spinal AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sherif M. S. Mowafy, Zagazig University
- Investigators
- Sherif M. S. Mowafy, MD, Principal investigator, Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University,Shereen E. Abd Ellatif, MD, Study director, Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988982
- Sponsor's protocol ID
- 1270/13-5-2025
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
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.
PubMed 23165318Bromage 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.
PubMed 5322004Downie 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.
PubMed 68687314. 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.
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.
PubMed 32633409Cave 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.
PubMed 2148916011. 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.
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.
PubMed 29492448Muller 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.
PubMed 26049929Picard 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.
PubMed 26854285Afolayan 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.
PubMed 22943123
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Emulsion for Reversal of Spinal Anesthesia in Ambulatory Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06988982
- Acronym / sponsor ID
- 1270/13-5-2025
- Keywords
- lipid emulsion, spinal anesthesia, ambulatory surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ILE (Intravenous lipid emulsion group) | Experimental | Drug: Intravenous Lipid Emulsion 20%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 |
| Group C (control group) | Placebo comparator | Drug: Control (placebo) grouppatients will received equal volume of normal saline at the end of surgery |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient acceptance.
- Cooperative patient
- Age 21-70 years old.
- BMI ≤ 35 kg/m2
- ASA I - II.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Group ILE (Intravenous lipid emulsion group) |
| Control (placebo) grouppatients will receive equal volume of normal saline at the end of surgery | Drug | Group C (control group) |
Primary outcome
Time for complete sensory and motor regression (min)
Time frame: 6 hours after surgery
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.
11 secondary outcomes
Time for two segment sensory regression (min)
Time frame: 6 hours after surgery
Time to walk (min) without or with minimal assistance
Time frame: 6 hours after surgery
Time to Void (min)
Time frame: 6 hours after surgery
Time to be home-ready (min)
Time frame: 6 hours after surgery
Time to actual hospital discharge (min)
Time frame: 24 hours after surgery
Heart rate (HR), and arterial blood pressure (MAP)
Time frame: 6 hours after surgery
Numerical rating scale (NRS)
Time frame: 24 hours after surgery
Time to first rescue analgesia (min)
Time frame: 24 hours after surgery
Total dose of rescue analgesia (diclofenac sodium)
Time frame: 24 hours after surgery
Postoperative Complications.
Time frame: 2 weeks after surgery
Patient satisfaction
Time frame: 2 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 23165318Palumbo 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.
- Background: PubMed 5322004Bromage 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.
- Background: PubMed 686873Downie 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.
- Background14. 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: PubMed 32633409Tampakis 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.
- Background: PubMed 21489160Cave 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.
- Background11. 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.
- Background10. 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.
- Background9. 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.
- Background8. 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: PubMed 29492448Hoshino 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.
- Background: PubMed 26049929Muller 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.
- Individual participant dataSharing planned: Yes. all collected IPD
Related trials for Spinal Anaesthesia
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherif M. S. Mowafy, MD principal investigator
Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University,
Shereen E. Abd Ellatif, MD study director
Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Lipid Emulsion 20% in people with Spinal Anaesthesia and Spinal Anesthesia Evaluation, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for complete sensory and motor regression (min) (time frame: 6 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06988982, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.