Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia; Hyperbaric; Perianal Surgery; Prilocaine; Day-Case
• Intervention / Treatment: Drug: Hyperbaric prilocaine; Drug: Hyperbaric bupivacaine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperbaric prilocaine group; Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine.	Drug: Hyperbaric prilocaine; Patients will receive 1.5 ml (30 mg) 0.5% hyperbaric prilocaine.
Active Comparator: Hyperbaric bupivacaine group; Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine.	Drug: Hyperbaric bupivacaine; Patients will receive 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time till home readiness	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.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to block regression	The time to block regression will be from intrathecal injection until sensation is regained at the S1 dermatome.	6 hours postoperatively
Time of onset of motor block	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	Intraoperatively
Time to spontaneous voiding	Time to spontaneous voiding will be recorded.	24 hours postoperatively
Time to the 1st rescue analgesia	Time to the first request for the rescue analgesia will be recorded from end of surgery to first dose of pethidine administrated	24 hours postoperatively
Total ketorolac consumption	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).	24 hours postoperatively
Heart rate	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.	Every 10 min till the end of surgery (up to 1 hour)
Mean arterial pressure	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.	Every 10 min till the end of surgery (up to 1 hour)
Incidence of adverse events	Incidence of adverse events such as postoperative nausea and vomiting (PONV), voiding difficulty, or any other complication.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine; Prilocaine
• Other Study ID Numbers: 36264PR839/9/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No