About this trial
Objectives: To compare the effectiveness of erector spinae plane block (ESPB) and rectus sheath block (RSB) in providing postoperative analgesia after supraumbilical surgery in adult patients and their impact on the patient's outcomes.
Background: Supraumbilical surgery for hernia repair is the second-most-popular after surgical inguinal hernia repair and is accompanied by moderate to severe postoperative pain, so patients always require large doses of opioids within the first postoperative day. Because opioids have several adverse effects such as drowsiness, pruritus, nausea, and vomiting, regional analgesic techniques are an essential component of postoperative opioid-sparing analgesia. Previous studies have shown that regional analgesic techniques after abdominal wall surgeries can be an essential element of a postoperative pain management strategy with minimal adverse effects and hemodynamic responses.
ESPB provides both somatic and visceral analgesia to the abdominal wall, through the blockade of the anterior rami of spinal nerves and the rami communicants involving sympathetic nerve fibers. RSB provides analgesia to the anterior abdominal wall from the xiphoid process to the symphysis pubis, through the blockade of the anterior rami of the 7th to 12th intercostal nerves. The dermatomal distribution of ESPB and RSB makes them ideal regional analgesic techniques after abdominal surgery, and to our knowledge, there were no previous trials that studied the difference between them.
Patients and Methods: This was a prospective, randomized (1:1), double-blind clinical trial on 60 patients scheduled for elective supraumbilical surgery under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group E; general anesthesia with postoperative bilateral ultrasound-guided ESPB, whereas in group R; general anesthesia with postoperative bilateral ultrasound-guided RSB.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologists (ASA) physical status ≤ II
Age from 21 to 60 years
Body Mass Index (BMI) < 35 kg/m²
Disqualifiers
American Society of Anesthesiologists (ASA) physical status > II
Age < 21 years or > 60 years
Body Mass Index (BMI) ≥ 35
Local infection at the puncture site
Trial design
Parallel
Treatments tested in this trial
Erector Spinae Plane Block (ESPB)
Procedure/SurgeryPostoperative Bilateral Ultrasound-guided ESPB
Rectus Sheath Block (RSB)
Procedure/SurgeryPostoperative Bilateral Ultrasound-guided RSB
Treatment groups
Trial outcomes
Primary outcomes
Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)
The time interval between the block performance and the first request of postoperative analgesia
Secondary outcomes
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (30 minutes, 1h, 6h, 12h, 18h, 24h) after block performance
Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)
The total dose of the rescue analgesic consumed in the first 24 hours after block performance
Number of participants and Rate of Postoperative Complications
Number of participants and Rate of: Nausea, Vomiting, Hematoma formation, Bowel perforation, and Pneumothorax
Sponsors and contacts
Click on the lead sponsor to view all of their trials.