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US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
External oblique intercostal (EOI) block
Erector spinae plane block (ESPB)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Cholecystectomy, EOI block, ESP block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
  • patients with the American Society of Anesthesiologists (ASA) physical status I/II,
  • Patients scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

  • Allergy to local anaesthetics,
  • Infection at the site of injection,
  • Coagulopathy,
  • Chronic pain syndromes,
  • Prolonged opioid medication,
  • Patients who received any analgesic 24 h before surgery.

Sites / Locations

  • Assiut University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

External oblique intercostal (EOI) block

Erector spinae plane block (ESPB)

Arm Description

Outcomes

Primary Outcome Measures

Nalbuphine consumption in mg equivalent to morphine dose.
mg

Secondary Outcome Measures

Numerical Rating Scale (NRS) at rest and when coughing
11-point scale where 0=no pain and 10=worst pain
Analgesic drug consumption other than nalbuphine
in mg
Heart Rate
beats /min
Mean Arterial Pressure
mmHg
Incidence of Postoperative nausea & vomiting (PONV)
Number of patients developing PONV
Shoulder pain
Number of patients developing Shoulder pain

Full Information

First Posted
February 28, 2022
Last Updated
June 2, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05272280
Brief Title
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
Official Title
Ultrasound Guided External Oblique Intercostal (EOI) Block Versus Erector Spinae Plane Block (ESPB) for Postoperative Analgesia in Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the efficacy of USG-guided bilateral External oblique intercostal (EOI) block with Erector spinae plane block (ESPB) for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both External oblique intercostal fascial plane block and Erector spinae plane block are effective in providing post-operative analgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Cholecystectomy, EOI block, ESP block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
triple
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
External oblique intercostal (EOI) block
Arm Type
Active Comparator
Arm Title
Erector spinae plane block (ESPB)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
External oblique intercostal (EOI) block
Intervention Description
A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the external oblique muscle. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.
Intervention Type
Other
Intervention Name(s)
Erector spinae plane block (ESPB)
Intervention Description
A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of Local Anesthetic mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.
Primary Outcome Measure Information:
Title
Nalbuphine consumption in mg equivalent to morphine dose.
Description
mg
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) at rest and when coughing
Description
11-point scale where 0=no pain and 10=worst pain
Time Frame
at 1, 2,4 , 8, 16 and 24 hours postoperatively
Title
Analgesic drug consumption other than nalbuphine
Description
in mg
Time Frame
24 hours postoperatively
Title
Heart Rate
Description
beats /min
Time Frame
Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Title
Mean Arterial Pressure
Description
mmHg
Time Frame
Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Title
Incidence of Postoperative nausea & vomiting (PONV)
Description
Number of patients developing PONV
Time Frame
24 hours postoperatively
Title
Shoulder pain
Description
Number of patients developing Shoulder pain
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2, patients with the American Society of Anesthesiologists (ASA) physical status I/II, Patients scheduled for elective laparoscopic cholecystectomy. Exclusion Criteria: Allergy to local anaesthetics, Infection at the site of injection, Coagulopathy, Chronic pain syndromes, Prolonged opioid medication, Patients who received any analgesic 24 h before surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magdy M mahdy, MD
Phone
0109 650 2058
Email
magdymahdy84@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amr M.A. Thabet, MD
Phone
01068924262
Email
Amrthabet@aun.edu.eg
Facility Information:
Facility Name
Assiut University hospital
City
Assiut
State/Province
Assiut, Asyut Governorate, Egypt,
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Mahdy, Lecturer
Phone
01096502058
Email
magdy.mahdy@aun.edu.eg

12. IPD Sharing Statement

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US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy

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