Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries

NCT05819723 | Completed

• 1 other identifier: FMASU MS 99/2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain is a significant risk factor for delirium. This clinical trial will search whether analgesia produced by erector spinae block in elderly patients undergoing hip fracture surgeries reduces delirium or not!

Conditions

Delirium in Old Age

Outcome Measures

Primary Outcomes (1)

• post operative delirium

  occurrence and severity of cognitive dysfunction

  first days postoperative

Secondary Outcomes (1)

• complications from erector spinae block

  on the first and the second days postoperative

Study Arms (2)

spinal anesthesia only

ACTIVE COMPARATOR

The spinal anaesthesia will be done under a complete aseptic technique induced using 3ml bupivacaine 0.5% with 25μg fentanyl

Other: CAM score

spinal anesthesia with erector spinae block

ACTIVE COMPARATOR

The spinal anaesthesia will be done under a complete aseptic technique induced using 3ml bupivacaine 0.5% with 25μg fentanyl, then erector spinae block will be given The transverse process of the 4th lumbar vertebra will be identified 4-6 cm laterally to the midline. An echogenic needle will be inserted using the out-of-plane technique until it touches the transverse process. Following negative aspira¬tion, 20 ml of 0.25% bupivacaine will be injected

Other: CAM score

Interventions

CAM score OTHER

The CAM scores assess the presence of delirium rapidly and accurately and also differentiates delirium from other cognitive impairment with a sensitivity of 94-100% and specificity of 90-95%. It is an algorithm that consists of four features: (i) Acute and fluctuating variation in mental status, (ii) Inattention, (iii) Incoherent or disorganized thinking, and (iv) Altered level of consciousness. CAM scores indicate delirium if the first two features are present and either the third or fourth feature is present.

spinal anesthesia only; spinal anesthesia with erector spinae block

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>60 years.
• American Society of Anesthesiologists physical status I, II.
• Patients undergoing hip fracture surgeries under spinal anaesthesia

You may not qualify if:

• Allergy to local anaesthetics.
• Infection in the injection area.
• Regular medication with tranquillizers and/or antidepressants.
• CAM scores II-VI.
• Delayed fracture surgeries more than 48 hours.
• Intraoperative blood loss of more than 1000 ml.
• Patient refusal.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 69711, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Anesthesia

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 19, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

EG (1)