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Completed

NCT Number: NCT07025343

Does Intralipid Infusion Can Reverse the Spinal Anesthesia Effect in Day Case Surgery?

This study aims to evaluate the effect of intralipid infusion on reversing the spinal anesthesia effect in day case surgery.

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Key information

Conditions

Intralipid Infusion Day Case Surgery Spinal Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banha University

Banhā, Banha, 13511, Egypt

About this study

The increasing demand for day-case surgery has led to a growing interest in developing strategies to provide patients with a more convenient, cost-effective, and less invasive alternative to traditional inpatient procedures.

Spinal anesthesia, in particular, is a widely used technique in day-case surgery due to its ability to provide excellent analgesia with minimal side effects.

Intravenous lipid emulsion therapy is commonly used to treat local anesthetic systemic toxicity (LAST) and has demonstrated some efficacy in treating other drug toxicities, particularly cardiotoxicity from lipophilic drugs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 18 to 65 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-II.
  • Scheduled for day-case surgery under spinal anesthesia.
  • Time of surgery less than 90 min.

Exclusion criteria

  • Patients with contraindications for outpatient surgery or spinal anesthesia.
  • Local anaesthetic (LA) allergy.
  • Those receiving anticoagulant therapy.
  • Emergency cases.
  • Pregnant cases.

Treatment and study plan

Lipid emulsion

Other

Patients (>70kg will receive 100 ml, <70 will receive 1.5ml/kg) of 20% intravenous lipid emulsion at the end of surgery as a study group.

Primary outcomes

  1. Onset time of the motor block

    Time frame: Intraoperatively

    The onset time of the motor block using the modified Bromage scale will be assessed. The motor block will be measured when the maximum dermatomal spread is achieved using the modified Bromage scale (0: no motor block, 1: hip blocked, 2: hip and knee blocked, and 3: hip, knee, and ankle blocked).

Secondary outcomes

  1. Duration of motor block

    Time frame: Intraoperatively

    The motor block will be measured when the maximum dermatomal spread is achieved using the modified Bromage scale (0: no motor block, 1: hip blocked, 2: hip and knee blocked, and 3: hip, knee, and ankle blocked).

  2. Time till home readiness

    Time frame: 24 hours postoperatively

    The time to home readiness will be assessed as the time from the end of surgery until the patients reached a post-anesthesia discharge score (PADS) ≥9 and are able to void spontaneously.

  3. Time to the 1st rescue analgesia

    Time frame: 24 hours postoperatively

    Time to the first request for the rescue analgesia (time from end of surgery to first dose of tramadol administrated).

  4. Total tramadol consumption

    Time frame: 24 hours postoperatively

    Rescue analgesia of 100mg IV tramadol will be given if the numerical rating scale (NRS)> 3 to be repeated after 30 min if pain persists (with maximum dose 400mg) until the NRS < 4.

  5. Degree of pain

    Time frame: 24 hours postoperatively

    Each patient will be instructed about postoperative pain assessment with the numerical rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").

  6. Incidence of adverse events

    Time frame: 24 hours postoperatively

    Incidence of adverse events such as bradycardia, urinary retention, leg paralysis, or any other complication will be recorded.

  7. Time from the end of surgery till movement

    Time frame: 24 hours postoperatively

    Time from the end of surgery till movement will be recorded.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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