Day Case Surgery, Intralipid Infusion, Spinal Anesthesia
Conditions
Brief summary
This study aims to evaluate the effect of intralipid infusion on reversing the spinal anesthesia effect in day case surgery.
Detailed description
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.
Interventions
OTHERLipid emulsion
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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Onset time of the motor block | 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
| Measure | Time frame | Description |
|---|---|---|
| Time till home readiness | 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. |
| Time to the 1st rescue analgesia | 24 hours postoperatively | Time to the first request for the rescue analgesia (time from end of surgery to first dose of tramadol administrated). |
| Total tramadol consumption | 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. |
| Duration of motor block | 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). |
| Incidence of adverse events | 24 hours postoperatively | Incidence of adverse events such as bradycardia, urinary retention, leg paralysis, or any other complication will be recorded. |
| Time from the end of surgery till movement | 24 hours postoperatively | Time from the end of surgery till movement will be recorded. |
| Degree of pain | 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). |
Countries
Egypt
Outcome results
None listed