An interventional study of Intravenous Lipid Emulsion 20% and Control (placebo) group in Spinal Anaesthesia, Spinal Anesthesia Evaluation and Ambulatory Surgery, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Zagazig University · Not applicable, Interventional, and Other
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.
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.
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Exclusion Criteria:
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%
patients will received equal volume of normal saline at the end of surgery
Drug: Control (placebo) group
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
patients will receive equal volume of normal saline at the end of surgery
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.
Time frame: 6 hours after surgery
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)
Time frame: 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.
Time frame: 6 hours after surgery
Time to Void (min)
the time from the ILE administration time (T0) till the patients first urinate.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks after surgery
Patient satisfaction
Patient satisfaction using a 3-point Likert scale (3=satisfied, 2= neutral, 1=dissatisfied).
Time frame: 2 weeks after surgery
Plan to share: Yes — all collected IPD
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Zagazig University