Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202310712142038 Date of Approval: 13/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound-Guided Erector Spinae Plane Block Versus External Oblique Intercostal Plane Block in Patients Undergoing Laparoscopic Cholecystectomy
Official scientific title Analgesic Effect of Ultrasound-Guided Erector Spinae Plane Block Versus External Oblique Intercostal Plane Block in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial The External oblique intercostal plane (EOI) block is a recent described technique for upper midline and lateral abdominal wall analgesia. Elsharkawy et al. demonstrated the potential mechanism of this technique with a cadaveric study reporting consistent staining of both lateral and anterior branches of intercostal nerves T7-T10 aim :evaluate the analgesic effect of bilateral erector spinae plane block versus bilateral external oblique intercostal plane block in patients undergoing Laparoscopic Cholecystectomy ,opioid consumption and haemodynamic changes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EOI vsESP
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/08/2023
Actual trial start date 02/09/2023
Anticipated date of last follow up 01/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 93
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL IN anasthesia and analgesia journals and pain manegement journals
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group erector spine block ESP g. A volume of 20 mL of Local Anesthetic mixture (10 mL of bupivacaine 0.5%, 1 mL of dexamethasone and 9 mL of normal saline to make a mixture totaling 20 ml.) will be injected. once after induction While the patient is in lateral position and after disinfecting the skin, a high-frequency linear ultrasound probe will be placed in a longitudinal 9 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 22-G, 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 muscl 31
Experimental Group External oblique intercostal block 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 1 mL of dexamethasone and 9 mL of normal saline to make a mixture totaling 20 ml.) will be injected. T once preoperative high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line. A 22-G, 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 musc 31
Control Group control group normal saline once preoperative will receive our institute's standard analgesia plan with no block 31 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2, 2. patients with the American Society of Anesthesiologists (ASA) physical status I/II, 3. Patients scheduled for elective laparoscopic cholecystectomy 1. Allergy to local anesthetics. 2. Infection at the site of injection. 3. Coagulopathy. 4. Chronic pain syndromes. 5. Prolonged opioid medication. 6. Patients who received any analgesic 24 h before surgery Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/04/2023 institutional review board
Ethics Committee Address
Street address City Postal code Country
yaseen abdelghafar shebeen elkoom 23456 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the analgesic effect of different modalities of analgesia (ESP block, EOI block and conventional fentanyl analgesia) in patients scheduled for laparoscopic cholecystectomy regarding the first request for analgesia Time for the first request for rescue analgesia ,Postoperative after patient transportation and stabilization in ward and after 2,6,12,18 and 24 hours in the ward.
Secondary Outcome 1. Postoperative pain severity as evaluated by Numerical Rating scale (NRS). 2. Postoperative consumption of additional opioids within the first 24 hours after surgery. 3. Hemodynamic variables (HR and MAP). 4. Incidence of postoperative nausea and vomiting (PONV). 5. Shoulder pain. Time for the first request for rescue analgesia ,Postoperative after patient transportation and stabilization in ward and after 2,6,12,18 and 24 hours in the ward.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NAtional liver institute yassen abdelghafa street shebeen elkom 23456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yaseen abdelghafar shebeen elkom 23456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor natioanl liver institute yassen abdelghafar shebeen elkoom 23456 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed Dawoud mohameddawoud24.md@gmail.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt resident
Role Name Email Phone Street address
Scientific Enquiries mohamed Dawoud mohameddawoud24.md@gmail.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt resident
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt lecturer of anasthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we intend sharing study protocol , aim of the work, patient and method and the results when be available.sharing of de-identified individual trial participant data.by email or to the intrnational journals which need the data or concerned in ultrasound-Guided Erector Spinae Plane Block and External Oblique Intercostal Plane Block in Patients Undergoing Laparoscopic Cholecystectomy Study Protocol when the results will be available study protocol. investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
international anasthesia and analgesia journal No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information