Shoulder Arthroscopy, Postoperative Analgesia, Erector Spinae Plane Block, Intraarticular Injection
Conditions
Brief summary
To improve the outcome after surgery, effective pain control is needed. The aim of the current study was to compare the efficacy of ultrasound guided erector spinae plane block versus the intra articular injection of local anesthetic for post-operative analgesia in patients undergoing shoulder arthroscopy.
Detailed description
Sample size calculation: Calculation of sample size was done to detect a 15% difference in the VAS score between two groups detected that at least 27 patients were needed at an α error of 0.05 and 80 % power of the study. The number will be increased to 30 patients to avoid a 10% dropped out patients. Statistical analysis Statistical analysis will be done by Statistical Package for the Social Sciences (SPSS) v25 (IBM Inc., Chicago, USA). Normality of data will be checked with Shapiro-Wilks test and histogram. Quantitative variables will be presented as mean and standard deviation (SD) and will be compared by unpaired student T test. Categorical variables will be presented as frequency and percentage (%) and will be analysed by the Chi-square test. P value \< 0.05 will be considered statistically significant.
Interventions
PROCEDUREErector Spinae Plane Block
The patient will be placed in the lateral position. Following skin disinfection, counting down from the C7 spinous process and using ultrasound guidance, the level of T2 transverse process will be identified. A 2-5 MH2 curved array transducer (sono site Edge, Bothell, Will behington) will be positioned transversely to visualize the lateral tip of T2 transverse Process. A longitudinal parasagittal orientation will be obtained over the transverse process using a 22 - gauge 8 cm block needle (visioplex, Vygon , France) will be inserted in plane to US beam in a caudal to cranial direction to place the needle tip between the posterior fascia of the erector spinae muscle and the T2 transverse process. Position of the needle tip in the ESP deep to the erector spinae muscle will be confirmed using hydrodissection with 0.5 - 1 ml of normal saline and visualization of the linear fluid spread deep to the erector spinae muscle following which 20 ml of 0.25% bupivacaine will be injected.
PROCEDUREIntraarticular Injection
Intraarticular injection of local anesthetic through the surgical port
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) physical status I-II * Posted for elective shoulder arthroscopy
Exclusion criteria
* Coagulopathy * Allergy to local anesthetics * Chronic use of narcotics * Necessity for an intra articular drain after surgery * Patients refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The amount of total postoperative rescue analgesic consumption (mg) | First 24 hours postoperative | Rescue analgesia in the form of diclofenac sodium 75mg intramuscularly (IM) will be given if the visual analogue scale ≥ 40 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative visual analogue scale | First 24 hours postoperative | Visual analogue scale (VAS) for determination of intensity of the pain on scale from (0-100) where 0= no pain and 100=the worst pain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The time to first request of rescue analgesia (hours) | First 24 hours postoperative | Time till the first need of rescue analgesia in the form of diclofenac sodium 75mg postoperative |
Countries
Egypt
Outcome results
None listed