NCT05609565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

November 3, 2022

Last Update Submit

November 23, 2024

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • The duration of motor block (minutes)

    The duration of motor block (minutes)

    24 hours postoperatively

Study Arms (2)

Group 1

ACTIVE COMPARATOR
Drug: spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine

Group 2

ACTIVE COMPARATOR
Drug: spinal anesthesia with bupivacaine

Interventions

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

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

Group 1
spinal anesthesia with bupivacaineDRUG

spinal anesthesia with bupivacaine

Group 2

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, SpinalBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 8, 2022

Study Start

November 15, 2022

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)