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

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector Spinae Plane Block (ESPB)
Rectus Sheath Block (RSB)
Sponsored by
Damanhour Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain focused on measuring Erector Spinae Plane Block, Rectus Sheath Block, Regional Analgesia

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Damanhour Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group E (n=30)

Group R (n=30)

Arm Description

Erector Spinae Plane Block

Rectus Sheath Block

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
December 17, 2021
Last Updated
September 25, 2023
Sponsor
Damanhour Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05179928
Brief Title
Erector Spinae Plane Block Versus Rectus Sheath Block for Postoperative Analgesia After Supraumbilical Surgery
Official Title
Is Erector Spinae Plane Block More Effective Than Rectus Sheath Block for Postoperative Analgesia After Supraumbilical Surgery in Adult Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damanhour Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Erector Spinae Plane Block, Rectus Sheath Block, Regional Analgesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group E (n=30)
Arm Type
Active Comparator
Arm Description
Erector Spinae Plane Block
Arm Title
Group R (n=30)
Arm Type
Active Comparator
Arm Description
Rectus Sheath Block
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block (ESPB)
Intervention Description
Postoperative Bilateral Ultrasound-guided ESPB
Intervention Type
Procedure
Intervention Name(s)
Rectus Sheath Block (RSB)
Intervention Description
Postoperative Bilateral Ultrasound-guided RSB
Primary Outcome Measure Information:
Title
Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)
Description
The time interval between the block performance and the first request of postoperative analgesia
Time Frame
24 hours after block performance
Secondary Outcome Measure Information:
Title
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
Description
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
Time Frame
24 hours after block performance
Title
Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)
Description
The total dose of the rescue analgesic consumed in the first 24 hours after block performance
Time Frame
24 hours after block performance
Title
Number of participants and Rate of Postoperative Complications
Description
Number of participants and Rate of: Nausea, Vomiting, Hematoma formation, Bowel perforation, and Pneumothorax
Time Frame
24 hours after block performance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Shaat, MD
Phone
00201223482709
Email
ahmedshaat99@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Shaat, MD
Organizational Affiliation
Damanhour Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damanhour Teaching Hospital
City
Damanhūr
State/Province
El-Beheira
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M Shaat, MD
Phone
00201223482709
Email
ahmedshaat99@gmail.com

12. IPD Sharing Statement

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

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