Intrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone for Ambulatory Knee Arthroscopy

April 14, 2024 updated by: Ibrahim Mamdouh Esmat, Ain Shams University

Hybrid Anesthesia for Ambulatory Knee Arthroscopy Using Intrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone: a Randomized Controlled Trial

- Although bupivacaine is safe and has a low rate of transient neurologic symptoms, the prolonged sensory and motor block is a drawback for day-case spinal anesthesia.Intrathecal hyperbaric prilocaine causes a much shorter motor block, with a similar onset time and lower inter-individual variability in motor block duration. Furthermore, the peripheral nerve block is used as an adjunct to the spinal anesthesia to prolong the surgical anesthetic conditions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) score I-II.
  • Body mass index < 35 kg/m2

Exclusion Criteria:

  • Patient's refusal.
  • Known coagulopathy.
  • Known peripheral neuropathy or neurological deficits.
  • Known allergy to study drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Drug: spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine
spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine
Active Comparator: Group 2
Drug: spinal anesthesia with bupivacaine
spinal anesthesia with bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The duration of motor block (minutes)
Time Frame: 24 hours postoperatively
The duration of motor block (minutes)
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2022

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

July 15, 2024

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS 706/ 2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

3
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