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.: PACTR202405826827983 Date of Approval: 23/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound Guided External Oblique Intercostal Plane Block versus Patient Controlled Analgesia in Surgeries of Subcostal Incisions
Official scientific title Analgesic Effect of Postoperative Ultrasound Guided External Oblique Intercostal Plane Block versus Patient Controlled Analgesia in Surgeries of Subcostal Incisions
Brief summary describing the background and objectives of the trial The advantages of effective postoperative pain management include patient comfort and therefore satisfaction, earlier mobilization, fewer pulmonary and cardiac complications, Ultrasound-guided fascial plane blocks have been rapidly incorporated into regional anesthesia practice in recent years as analternative to neuraxial techniques External oblique intercostal block to be a simple, convenient,effective and opioid-sparing regional anaesthetic technique for postoperative analgesia it could be incorporated into enhanced recovery protocols for hepatobiliary surgery.The goal of PCA is to efficiently deliver pain relief at a patient’spreferred dose and schedule by allowing them to administer a predetermined bolus dose of medication on-demand at the press of a button.the objectives are to investigate the efficacy of both Ultrasound Guided External Oblique Intercostal Plane Block versus Patient Controlled Analgesia postoperative in surgeries with subcostal incisions
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EOIP vs PCA
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 01/02/2024
Actual trial start date 01/02/2024
Anticipated date of last follow up 01/01/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL anasthesia and analgesia journal
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
Control Group patient controlled analgesia dose of (3 mg base rate/h, 1 mg bolus, 20 min lock out) for 24 hours Nalbuphine will be used in patient controlled analgesia PCA with dose of (3 mg base rate/h, 1 mg bolus, 20 min lock out) 20 Active-Treatment of Control Group
Experimental Group external oblique intercostal plane block 20 mL of LA (10 mL of bupivacaine 0.5% and 10 mL of normal saline to make a mixture totaling 20 ml.) once at the end of operation 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 (10 mL of bupivacaine 0.5% and 10 mL of normal saline to make a mixture totaling 20 ml.) will be injected 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age between 18 and 65 years. 2. Patients with the American Society of Anesthesiologists (ASA) physical status I/II. 3. Body mass index (BMI) of 18-35 kg/m2. 4. Gender: both sexes. 1. Patient refusal. 2. Coagulopathy. 3. Allergy to local anesthesics. 4. Infection at the site of injection. 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 01/01/2024 faculty of medicine
Ethics Committee Address
Street address City Postal code Country
yassen abdelghafar shebeen elkoom 23456 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate [Visual analogue score (VAS)] after patient transportation and stabilization in ICU and after 2, 6, 12, 18 and 24 hours in the ICU
Secondary Outcome 1.To evaluate the opoid consumption between two groups postoperative. 2. Hemodynamic variables (HR & mean ABP). 3. Incidence of postoperative nausea and vomiting. 4. Assesment of sedation postoperative by Ramsayscore after patient transportation and stabilization in ICU and after 2, 6, 12, 18 and 24 hours in the ICU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national liver institute yassen abdelghafar shebeen elkoom 23456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yassen addelghafar shebeen elkoom 23456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor national 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 Rania Mabrouk hanaarashed2020@yahoo.com 0012345667 yassen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt anasthesia resident
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 01001378542 yassen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt anasthesia lecturer
Role Name Email Phone Street address
Scientific Enquiries hanaa rashed hanaarashed2020@yahoo.com 01001378542 yassen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt anasthesia lecturer
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. Study Protocol when the result be available will be puplished search by Postoperative Ultrasound Guided External Oblique Intercostal Plane Block
URL Results Available Results Summary Result Posting Date First Journal Publication Date
in anasthesia and analgesia journals 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