Trials Sponsors Conditions Drugs Pricing

Conditions

Lower Limb Fracture

Outcome Measures

Primary Outcomes (1)

Total intraoperative and postoperative opioid consumption
The total fentanyl doses consumed in the entire operative procedure and morphine consumed for 24 hours postoperative will be calculated.
Total fentanyl used intraoperative and total morphine consumed up to 24 hours postoperative

Secondary Outcomes (2)

(NRS) score assessment pre-block, 30 min post-block , and postoperatively in the recovery room, and then it will be repeated 3 h, 6h, 12h, and 24, hours
preoperative and postoperatively pain (NRS) score assessment for 24 hours
Block success assessment using perfusion index (PI) before and after performing the block
Recording Perfusion index readings at baseline and 10, 20, 30 min. post block

Study Arms (2)

Control group

PLACEBO COMPARATOR

patients who will be recruited in the control group will receive general anesthesia only

Procedure: one point combined Lumbar and sacral plexus block

Interventional group

ACTIVE COMPARATOR

Patients who will be recruited in the Interventional will receive one point combined lumbar and sacral plexus block. then they will receive general anesthesia

Procedure: one point combined Lumbar and sacral plexus block

Interventions

one point combined Lumbar and sacral plexus blockProcedure

performing an ultrasound-guided one-point combined Lumbar and sacral plexus block using a one-point puncture. Block success will be assessed using the perfusion index (PI) before and after performing the block

Also known as: No block intervention in control group

Control groupInterventional group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

ASA I-II.
patients scheduled for unilateral femur or tibial surgery necessitate knee joint intervention

Sponsors & Collaborators

Zagazig University
Governmentlead

Study Sites (1)

Faculty of Medicine - Zagazig University

Zagazig, 44519, Egypt

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

Naglaa Abdelhaleem, MD
Faculty of medicine, Zagazig University Hospitals
PRINCIPAL INVESTIGATOR

Enrollment

56 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details: Randomization assignments will be kept in sealed envelopes until all preprocedural measurements will be completed
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine

Study Record Dates

First Submitted

August 25, 2023

First Posted

August 31, 2023

Combined Lumbar and Sacral Branches Block Through the Ilio-Psoas Muscle Spaces for Analgesia of Lower Limb Surgeries

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Control group

Interventional group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Control group

Interventional group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations