Continuous Spinal Anesthesia Versus Epidural Anesthesia in Geriatric

NCT06340256 | Completed

• 1 other identifier: IRB0000871253
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

60 patients aged older than 60 years, American Society of Anesthesiologists (ASA) class II or III and scheduled for major hip surgery will be randomized, in to two groups anesthetized using continuous spinal anesthesia or using continuous epidural anesthesia.

Conditions

Epidural Catheter

Outcome Measures

Primary Outcomes (1)

• Hemodynamic changes

  mean arterial blood pressure

  during the surgery

Secondary Outcomes (1)

• Patient satisfaction

  immediately after the surgery

Study Arms (2)

Group !

ACTIVE COMPARATOR

Continuous spinal anesthesia

Other: Continuous spinal anesthesia

Group 2

ACTIVE COMPARATOR

Continuous epidural anesthesia

Other: Continuous epidural anesthesia

Interventions

Continuous spinal anesthesia OTHER

The Catheter will be then fed over the needle into the intrathecal space and Inserted 3cm cephalad into the subarachnoid space.The spinal needle and the modified Tuohy needle will be then removed, and a Luer connector and A filter previously filled with the anesthetic solution will be attached to the Catheter (priming volume 0.6ml). Plain bupivacaine 0.5% in 20ml vials will Be used CSA group received 1 ml(5 mg) of plain bupivacaine (0.5%) Together with fentanyl l25μg injected via the catheter at a rate of 0.2ml/15s. The level of the resulting sensory blockade will be tested using pin prick.

Group !

Continuous epidural anesthesia OTHER

The needle is advanced until the epidural space is identified by the loss-of-resistance technique, and then a 20G catheter is inserted 3 cm cephalad into the epidural space. a test dose of 3ml of 2% lignocaine with adrenaline (1:200000) will be injected into the catheter. Three minutes later, 10 ml of plain bupivacaine (0.5%) together with fentanyl l50μg will be injected via the catheter.

Group 2

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged older than 60 years
• American Society of Anesthesiologists (ASA) class II or III
• scheduled for major hip surgery

You may not qualify if:

• Refusal
• Infection at the injection site
• Spinal deformity
• Neuropathy
• Allergy to local anesthetics
• Coagulopathy

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Al-Azhar Faculty of Medicine

Asyut, Egypt

Location

Related Publications (1)

• Imbelloni LE, Gouveia MA, Cordeiro JA. Continuous spinal anesthesia versus combined spinal epidural block for major orthopedic surgery: prospective randomized study. Sao Paulo Med J. 2009 Jan;127(1):7-11. doi: 10.1590/s1516-31802009000100003.

  PMID: 19466288 RESULT

Study Officials

• Hussein Thabet

  Al-Azhar Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Of Anesthesia and ICU

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: April 1, 2024
• Study Start: September 18, 2021
• Primary Completion: August 2, 2023
• Study Completion: August 15, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)