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

NCT ID: NCT05609565

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2024-09-30

Brief Summary

• 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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group 1

Group Type: ACTIVE_COMPARATOR

spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine

Intervention Type: DRUG

spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine

Group 2

Group Type: ACTIVE_COMPARATOR

spinal anesthesia with bupivacaine

Intervention Type: DRUG

spinal anesthesia with bupivacaine

Interventions

spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine

spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine

Intervention Type: DRUG

spinal anesthesia with bupivacaine

spinal anesthesia with bupivacaine

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Mamdouh Esmat

Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain-Shams University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MS 706/ 2022

Identifier Type: -

Identifier Source: org_study_id