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NCT Number: NCT06600048

Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery

The aim of this study is to evaluate the effect of spinal anesthesia by hyperbaric prilocaine in day-case perianal surgery.

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Key information

Conditions

Spinal Anesthesia Day-Case Hyperbaric Perianal Surgery Prilocaine

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

Day-case spinal anesthesia with short-acting local anesthetics such as lidocaine and chloroprocaine can provide short times to discharge. However, the association of lidocaine with transient neurologic symptoms (TNS) and chloroprocaine with neurologic injury has limited the use of these agents in spinal anesthesia.

Hyperbaric bupivacaine has been used for spinal anesthesia for decades owing to the low incidence of TNS.

Prilocaine is also an amide local anesthetic that has an intermediate duration of action. It is available in the hyperbaric form that can be used for spinal anesthesia in day-case surgeries.

Hyperbaric prilocaine provides faster spinal block onset and earlier patient recovery in ambulatory surgery compared to plain prilocaine.

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 perianal surgery under spinal anesthesia.

Exclusion criteria

  • Allergy to the studied drugs.
  • Patients with contraindications to spinal anesthesia.
  • Patients with advanced cardiac, renal, or hepatic diseases.
  • Previous voiding difficulty.
  • Patients taking anticholinergic medications.
  • Time of surgery exceeds 75 min.

Treatment and study plan

Hyperbaric prilocaine

Drug

Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine.

Hyperbaric bupivacaine

Drug

Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine.

Primary outcomes

  1. 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 were able to void spontaneously or receive a urinary catheter, and the sensory block resolved to the S3 dermatome.

Secondary outcomes

  1. Time to block regression

    Time frame: 6 hours postoperatively

    The time to block regression will be from intrathecal injection until sensation is regained at the S1 dermatome.

  2. Time of onset of motor block

    Time frame: Intraoperatively

    The time of onset of the motor block will be assessed from intrathecal injection of local anesthetic until a grade 3 Bromage score is achieved

  3. Time to spontaneous voiding

    Time frame: 24 hours postoperatively

    Time to spontaneous voiding will be recorded.

  4. Time to the 1st rescue analgesia

    Time frame: 24 hours postoperatively

    Time to the first request for the rescue analgesia will be recorded from end of surgery to first dose of pethidine administrated

  5. Total ketorolac consumption

    Time frame: 24 hours postoperatively

    Total ketorolac consumption will be recorded. If the numerical rating scale (NRS) becomes ≥3, 30 mg ketorolac IM will be given when needed (maximum every six hours).

  6. Heart rate

    Time frame: Every 10 min till the end of surgery (up to 1 hour)

    Heart rate will be recorded throughout the operation: every 5 minutes for the first 15 minutes and every 10 minutes until the end of the surgery.

  7. Mean arterial pressure

    Time frame: Every 10 min till the end of surgery (up to 1 hour)

    Mean arterial pressure will be recorded throughout the operation: every 5 minutes for the first 15 minutes and every 10 minutes until the end of the surgery.

  8. Incidence of adverse events

    Time frame: 24 hours postoperatively

    Incidence of adverse events such as postoperative nausea and vomiting (PONV), voiding difficulty, or any other complication.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Mar 27, 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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