Erector Spinae Plane Block Versus Rectus Sheath Block for Postoperative Analgesia After Supraumbilical Surgery

Post Operative Pain Clinical Trial

Official title:

Is Erector Spinae Plane Block More Effective Than Rectus Sheath Block for Postoperative Analgesia After Supraumbilical Surgery in Adult Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179928
• Other study ID #: DTH: 21004
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2023
• Source: Damanhour Teaching Hospital
• Contact: Ahmed M Shaat, MD
• Phone: 00201223482709
• Email: ahmedshaat99[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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; carried out 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologist (ASA) physical status = II

• Age from 21 to 60 years

• Body Mass Index (BMI) < 35 kg/m²

Exclusion Criteria:

• 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

• Altered mental status

• Pregnant women

• Allergy to study drugs

• Chronic pain

• Coagulation abnormalities or on anticoagulants

• Severe hepatic or kidney disease

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Erector Spinae Plane Block (ESPB)
Postoperative Bilateral Ultrasound-guided ESPB
• Rectus Sheath Block (RSB)
Postoperative Bilateral Ultrasound-guided RSB

Locations

Country	Name	City	State
Egypt	Damanhour Teaching Hospital	Damanhur	El-Beheira

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours after block performance
Secondary	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	24 hours after block performance
Secondary	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	24 hours after block performance
Secondary	Number of participants and Rate of Postoperative Complications	Number of participants and Rate of: Nausea, Vomiting, Hematoma formation, Bowel perforation, and Pneumothorax	24 hours after block performance