Continuous Spinal Anesthesia Versus Epidural Anesthesia in Geriatric

NCT ID: NCT06340256

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-18
• Study Completion Date: 2023-08-15

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.

Detailed Description

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.

In continuous spinal anesthesia group 22 G catheter with priming volume0.1m 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.

Continuous epidural anesthesia Group A Perifix 401filter epidural set.It is composed of Tuohy epidural needle1.3×80 mm (18G);an epidural catheter with three lateral openings 0.85×0.45×1000 mm (20G); loss-of-resistance syringe, 10 ml; a Perifix flat filter 0.2μm; and Perifix screw connector. 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 spac e. 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. If the sensory blockade don't reach T10 within 20 min of the administration of the initial dose, additional doses of 5 ml of plain bupivacaine 0.5% will be injected epidurally every10 min until the level of T10 or amaximum of 25 ml of plain bupivacaine 0.5 % will be achieved. If the sensory blockade don't not reach T10, anesthetic failure will be considered, and the patients will be excluded from the study.

Conditions

Epidural Catheter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Group !

Continuous spinal anesthesia

Group Type: ACTIVE_COMPARATOR

Continuous spinal anesthesia

Intervention Type: 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 2

Continuous epidural anesthesia

Group Type: ACTIVE_COMPARATOR

Continuous epidural anesthesia

Intervention Type: 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.

Interventions

Continuous spinal anesthesia

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.

Intervention Type: OTHER

Continuous epidural anesthesia

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrady S Ibrahim, MD

Professor Of Anesthesia and ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hussein Thabet

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar Faculty of Medicine

Locations

Al-Azhar Faculty of Medicine

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: RESULT

PMID: 19466288 (View on PubMed)

Other Identifiers

IRB0000871253

Identifier Type: -

Identifier Source: org_study_id