Postoperative Nausea, Postoperative Pain, Postoperative Vomiting, Ventral Hernia
Conditions
Keywords
erector spinae plane block, external oblique intercostal plane block, bupivacain
Brief summary
The aim of this study is to compare the postoperative analgesic efficacy of bilateral erector spinae plane block and bilateral external oblique-intercostal plane block in patients undergoing open ventral hernia repair.
Detailed description
The effectiveness of trunk blocks applied at equivalent doses will be evaluated in order to most effectively treat postoperative pain, minimize nausea and vomiting, and optimize the comfort of patients during the postoperative period after open ventral hernia repair operations. The methods used in this study are proven safe in ventral hernia repair surgery and other abdominal surgeries, and are routinely performed in our clinic. The procedures performed pose no additional risks to patients compared to routine procedures.
Interventions
PROCEDUREErector Spine Plane Block
Bilateral erector spinae plane block was performed under aseptic conditions at the T7 vertebral level using ultrasound guidance with a convex probe. An 80-mm peripheral nerve block needle was inserted 3-4 cm lateral to the midline with an in-plane approach to the fascial plane deep to the erector spinae muscle. After negative aspiration and hydrodissection with 1-3 ml of saline, 30 ml of 0.25% bupivacaine was injected on each side, with craniocaudal spread confirmed by ultrasound. Patients were then positioned for surgery.
PROCEDUREExternal Oblique - Intercostal Plane Block
Bilateral external oblique-intercostal plane block was performed under aseptic conditions by identifying the 6th and 7th ribs along the midclavicular line. Using ultrasound guidance with the probe placed parallel to the midclavicular line, the ribs, intercostal muscles, external oblique muscle, and pleura were visualized. A 50-mm block needle was advanced craniocaudally into the plane between the external oblique and intercostal muscles. After negative aspiration and hydrodissection with 1-3 ml saline, 30 ml of 0.25% bupivacaine was injected on each side, with craniocaudal spread confirmed by ultrasound. Patients were then positioned for surgery.
Sponsors
Ankara Ataturk Sanatorium Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Block provider doesn't know peroperative process and the patient's postoperative assesment. Anesthesia provider doesn't know the block type and the patient's postoperative assesment. Outcomes assessor doesn't know about the block type and intraoperative process.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for open ventral hernia repair under general anesthesia * Patients with ASA scores (American Society of Anesthesiologists) 1 and 2 * Patients with a body mass index between 18.5 and 34.9
Exclusion criteria
* Patients scheduled for open ventral hernia repair under spinal or epidural anesthesia * Patients who have previously undergone spine surgery. * Patients with known local anesthetic allergy * Pregnant women * Mentally uncooperative patients * Patients with a history of chronic analgesic use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tramadol Consumption | 24 hours | The primary endpoint of the study was whether tramadol consumption in the first 24 hours was significantly different between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remifentanil Consumption | 1 hour | The amount of remifentanil consumption required to maintain normal vital signs during the intraoperative period. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nausea and Vomiting | 24 hours | Nausea and vomiting according to Visual Analog Scale that can be observed at the 2nd and 24th postoperative hours.This scale consists of a 100-millimeter line, with 0 representing no symptoms and 100 representing the most severe symptoms ever experienced. Patients are asked to mark the intensity they feel on the line. A numerical value is then obtained by measuring the millimeter at which the mark appears. |
| Gas and Stool | 24 hours | Time to pass gas or stool for the first time in the postoperative period. |
| Pittsburgh Sleep Quality Index score | 24 hours | Evaluation of patients' sleep in the last month according to the Pittsburgh Sleep Quality Index score. The Pittsburgh Sleep Quality Index consists of seven components, each scored 0-3, yielding a global score of 0-21. Higher scores reflect poorer sleep quality, with a global score \>5 indicating clinically significant sleep disturbance. |
| Additional Analgesia | 24 hours | The time when patients request painkiller for the first time despite their existing analgesia plan. |
| Pain Scores | 24 hours | Difference between pain scores according to Visual Analog Scale at the 2nd and 24th postoperative hours. This scale consists of a 100-millimeter line, with 0 representing no symptoms and 100 representing the most severe symptoms ever experienced. Patients are asked to mark the intensity they feel on the line. A numerical value is then obtained by measuring the millimeter at which the mark appears. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAli KOC, MD
Backup ContactMunire BABAYIGIT, Assoc. Prof.
Outcome results
None listed