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.: PACTR202311829665308 Date of Approval: 23/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title External Oblique Intercostal Plane Block versus Pre-Incisional Local Wound Infiltration on Intra and Acute Postoperative Pain Control in Adult Patients Undergoing Bariatric Surgeries
Official scientific title External Oblique Intercostal Plane Block versus Pre-Incisional Local Wound Infiltration on Intra and Acute Postoperative Pain Control in Adult Patients Undergoing Bariatric Surgeries: A Randomized Controlled Study
Brief summary describing the background and objectives of the trial Postoperative pain can result in severe patient suffering, impede healing, and raise medical expenses. Laparoscopic bariatric surgery is minimally invasive; however, it can be very painful. The external oblique intercostal plane block is an innovative motor- and opioid-sparing approach that inhibits anterior and lateral cutaneous branches of thoracoabdominal nerves, which innervate the upper abdominal quadrant. Therefore, this block covers the area of both upper quadrants of the abdomen including the midline area. This work investigated the efficacy of external oblique intercostal plane block compared to pre-incisional local wound infiltration with local anesthetic agents on intra and acute postoperative pain control in bariatric surgery. This randomized controlled study enrolled 72 adult patients between the ages of 21 and 60, of both sexes who were scheduled for bariatric surgery. The patients were randomized into two groups. Group A were administered an external oblique intercostal plane block (25 ml of 0.25% bupivacaine and 1% Lidocaine mixture on each side). Group B were administered pre-incisional local wound infiltration using 5 ml of equal mixture of 0.25% bupivacaine and 1% lidocaine at each port site before skin incision.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 01/11/2022
Actual trial start date 01/11/2022
Anticipated date of last follow up 31/07/2023
Actual Last follow-up date 31/07/2023
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
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 External Oblique Intercostal Plane Block Before the surgical procedure The block was performed under complete aseptic methods. Under ultrasonography, the sixth rib's location was identified and marked on the skin using a counting-down method starting with the first rib. After placing a 5–12 MHz linear probe over the chest wall on the sixth rib just medial to the anterior axillary line parasagittal in orientation, the needle (which is an 18-gauge cannula needle) was advanced through the skin from cephalad to caudal. We saw by ultrasound the external oblique muscle, the only superficial structure to the chest wall (ribs) in this area. Then, we injected 25 ml of an equal mixture of (0.25% bupivacaine and 1% Lidocaine) below the external oblique muscle until it is well-lifted by the LA agent. 36
Control Group Pre incisional local wound infiltration Before the surgical procedure We performed pre-incisional local wound infiltration with a local anesthetic agent using 5 ml of equal mixture of 0.25% bupivacaine and 1% lidocaine at each port site before skin incision. During intraoperative monitoring for both studied groups, Any an unexplained change in hemodynamics (whenever the mean blood pressure, heart rate, or both were elevated by more than 20% from the baseline) denoted that the patient was in pain. So, fentanyl incremental doses (0.5 μg/kg) were given. 36 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Aged 21 to 60 Both sexes ASA I or II Planned for bariatric surgery Chronic opioid use Seizures Life-threatening medical condition Severe systemic diseases Allergy to local anesthetic Severe hepatic disease Rib cage abnormalities Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 60 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 26/10/2022 MUST IRB
Ethics Committee Address
Street address City Postal code Country
26th of July Corridor 6th of October 12566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total amount of morphine given in the first 12 h postoperatively At the end of the 12 hours postoperatively
Secondary Outcome Intraoperative fentanyl consumption At the end of the surgical procedure
Secondary Outcome Pain At 2, 4, 6, 9, and 12 hours postoperatively
Secondary Outcome Hemodynamics -- Heart rate, Mean arterial pressure, and SpO2 Before induction of general anesthesia-T0, before launching the block-T1, 20 minutes after doing the block-T2, and at the end of surgery-T3
Secondary Outcome Intraoperative and postoperative side effects e.g. Nausea, Vomiting, Toxicity, and Pneumothorax During the surgical procedure and for 24 following the end of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Souad Kafafi University Hospital 26th of July Corridor 6th of October Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Yahya Hammad Kasr Alainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Souad Kafafi University Hospital 26th of July Corridor 6th of October Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yahya Hammad res.train.1111@gmail.com +201114048081 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries Yahya Hammad res.train.1111@gmail.com +201114048081 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Abdelrahman Mohamed Abdelrahmanbassyouny@gmail.com 000000000000 26th of July Corridor Street
City Postal code Country Position/Affiliation
6th of October City Egypt Department of Anesthesia Intensive Care and Pain Management Faulty of Medicine MUST University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 24 months following article publication. Study Protocol From 12 to 24 months after article publication The data will be available on reasonable request to the corresponding author, to be used for systematic reviews or meta-analyses.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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