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

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

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!

Study Overview

• Status: Not yet recruiting
• Conditions: Delirium in Old Age
• Intervention / Treatment: Other: CAM score

Detailed Description

This randomized controlled trial will include 120 elderly patients American Society of Anesthesiologists physical status I-II, aged more than 60 years old and undergoing fracture hip surgeries.

all patients will be examined for preoperative cognitive impairment using the short form of the Confusion Assessment Method Survey (CAM) and the long form will be used postoperatively.

The CAM scores 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.

Patients with a delirium of CAM score>1 will be excluded from the study. also, patients will be asked to rate their baseline pain levels using the numeric rating scales (NRS) from "no pain" to "worst possible pain". patients will be randomly divided into two equal groups Group 1: spinal anaesthesia only. Group 2: spinal anaesthesia with erector spinae block. In both groups, basic monitoring in the form of non-invasive blood pressure (NIBP), pulse oxygen saturation (SPO2)and 5-lead electrocardiogram (ECG) will be attached in the operating room(OR)

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

At the end of the operation patients in group 2 will receive the block at the lateral position.

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 aspiration, 20 ml of 0.25% bupivacaine will be injected.

patients will be monitored in the PACU for at least one hour by NIBP, SPO2, and ECG and any abnormality will be recorded and managed accordingly.

The cognitive functions will be re-evaluated one hour after the recovery from the surgery in PACU using the CAM scores. and on the first and the second days postoperatively using CAM score for occurrence and severity of cognitive dysfunction if present. Then every symptom will be rated and listed in the CAM-S as absent (0, mild (1), or severe (2), where higher scores indicate more severe delirium and patients with POD will be followed up and managed properly by neurologists. Patients in the two groups will be compared regarding the incidence and severity of delirium on the first and second postoperative days.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rania M Hussien, associate professor; Phone Number: 026213948; Email: drrania_maamon@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria: • History of neurological or psychiatric disease.

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: spinal anesthesia only; The spinal anaesthesia will be done under a complete aseptic technique induced using 3ml bupivacaine 0.5% with 25μg fentanyl	Other: CAM score; 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.
Active Comparator: spinal anesthesia with erector spinae block; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative delirium	occurrence and severity of cognitive dysfunction	first days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications from erector spinae block	block failure, haematoma	on the first and the second days postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Leg Injuries; Femoral Fractures; Hip Injuries; Delirium; Hip Fractures
• Other Study ID Numbers: FMASU MS 99/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No