Clinical trial NCT05819723: Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries
Official title: Analgesia Produced by Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium in Old Age
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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!

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.

Eligibility criteria: 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.

Primary outcomes:
measure: post operative delirium
timeFrame: first days postoperative
Secondary outcomes:
measure: complications from erector spinae block
timeFrame: on the first and the second days postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: