Analgesia Produced by Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- post operative delirium
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
post operative delirium
Time Frame: first days postoperative
occurrence and severity of cognitive dysfunction
Secondary Outcomes
- complications from erector spinae block(on the first and the second days postoperative)
Investigators
Rania Maher Hussien, MD
Associate professor of Anesthesia
Ain Shams University