Post Operative Pain
Conditions
Brief summary
This study aims to evaluate the effects of erector spinae plane block on intraoperative fentanyl consumption in patients undergoing abdominal hysterectomy under general anesthesia. To our knowledge, no study in the literature demonstrates this effect.
Detailed description
This study will be performed in Fayoum University hospital after approval of the institutional ethics committee and written informed consent. This study will be conducted as a prospective, randomized, double-blind, parallel-group clinical trial. Inclusion criteria: * American Society of Anesthesiologists (ASA) physical status I, II patients who will be scheduled for elective abdominal hysterectomy. * Age range above 18. Exclusion criteria: * Patient refusal. * Significant renal, hepatic and cardiovascular diseases. * History of allergy to one of the study drugs. * Any contraindication to regional anesthesia such as local infection or bleeding disorders. * Chronic opioid use, history of chronic pain and cognitive disorders. The patients will be randomized into two groups: ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of bupivacaine 0.25% on each side and Control group who will undergo the same procedure but with an injection of 20 ml of saline on a 1:1 ratio using a computer-generated random table. The patient's assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the ESP block and will not be involved in further data collection or patient care. The patients and both the surgical and anesthesia teams, who are responsible for patient care and data collection are blinded from the group assignments.
Interventions
PROCEDUREESP block
ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of bupivacaine 0.25% on each side
Sponsors
Fayoum University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This study will be conducted as a prospective, randomized, double-blind, parallel-group clinical trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
\- Inclusion criteria: * American Society of Anesthesiologists (ASA) physical status I, II patients who will be scheduled for elective abdominal hysterectomy. * Age range 18-70 years
Exclusion criteria
* Patient refusal. * Significant renal, hepatic, and cardiovascular diseases. * History of allergy to one of the study drugs. * Any contraindication to regional anesthesia such as local infection or bleeding disorders. * Chronic opioid use, history of chronic pain and cognitive disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total intraoperative fentanyl consumption (μg) | operative time in hours | the total doses of intraoperative fentanyl consumption in (μg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative sevoflurane consumption (ml) | operative time in hours | intraoperative sevoflurane consumption (ml) |
| post-operative fentanyl consumption in (μg) | the first 24 hours postoperative | post-operative fentanyl consumption in the first 24 hours (μg) |
| VAS score | the first 24 hours postoperative | visual analog score |
| mean operative times (min) | operative times in (min) | operative times duration in (min) |
Countries
Egypt
Outcome results
None listed