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.: PACTR202401642987715 Date of Approval: 25/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness between Ultrasound Guided Unilateral Transversus Abdominis Plane, Ilioinguinal/Iliohypogastric Nerve Blocks and Local Wound Infiltration for Post-operative Analgesia in Patients Undergoing Inguinal Hernia Surgery at Dilla University Referral Hospital: A randomized controlled trial.
Official scientific title Effectiveness between Ultrasound Guided Unilateral Transversus Abdominis Plane, Ilioinguinal/Iliohypogastric Nerve Blocks and Local Wound Infiltration for Post-operative Analgesia in Patients Undergoing Inguinal Hernia Surgery at Dilla University Referral Hospital: A randomized controlled trial.
Brief summary describing the background and objectives of the trial Pain management is crucially important in the postoperative period as it increases patient comfort and satisfaction. Poorly managed post post-herniorrhaphy pain is associated with delayed return to normal daily activities and may also be related to persistent (chronic) post herniorraphy pain. In addition, it may also leads to increase of oxygen expenditure and acid lactic production, which can stimulate autonomic nervous system and increase heart rate (HR) and cardiac output. Nerve blocks with local anesthetic agents (LA) are a method that can be used in inguinal hernia surgeries for both pain management and surgery. Iliohypogastric (IH) and ilioinguinal (II) nerve blocks are generally used for this inguinal hernia repair surgery. LA infiltration helps in pain management in acute postoperative period, it also decreases postoperative visual analogue scale (VAS) scores, opioid demand, and time to first rescue analgesic administration. TAP block provides analgesia to the parietal peritoneum and skin of the abdomen in infra-umbilical surgeries. But Most of the stated pain management modalities have been proved inconsistent. Therefore, the choice between ilioinguinal/ iliohypogastric, TAP block and local infiltration with regard to analgesic efficacy, duration of analgesia & post op analgesic drug consumption needs investigation for better practice of perioperative pain control and patient care. Furthermore, optimal pain management decreases sufferings associated with pain, duration of hospital stay and associated hospital cost, and increases patient satisfaction. The main objective this study will be to compare analgesic effectiveness between ultrasound guided unilateral TAP, Ilioinguinal/Iliohypogastric nerve Blocks and local wound infiltration for post-operative analgesia in adult patients undergoing inguinal hernia surgery at Dilla University Referral Hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/12/2023
Actual trial start date 30/01/2024
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date 30/07/2024
Anticipated target sample size (number of participants) 156
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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 by using procedures such as coin-tossing or dice-rolling 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 Transversus abdominis plane block Bupivacaine 0.25%, 15 ml NA Patients will be placed in supine position and with linear high frequency transducer; abdomen will be scanned between costal margin and iliac crest to identify the three muscular layers of abdomen. The probe position will be adjusted to visualize three muscular layers of abdominal wall, the external oblique (most superficial), the internal oblique and transverses abdominis muscles and the peritoneal cavity lies deep to the transversus abdominis muscle. A short-beveled needle of 50-100mm, 21-23 G will be inserted in an antero-posterior direction with in-plane approach. After confirming the tip of the needle between aponeurosis of internal oblique and transversus abdominis muscles, bupivacaine 0.25%, 20 ml will be injected with intermittent aspiration. The local anaesthetic spread will be seen as hypo-echoic shadow between the aponeurosis of the internal oblique and transversus abdominis muscles. 52 Active-Treatment of Control Group
Experimental Group Ilioinguinal iliohypogastric nerve block 10ml of 0.25% bupivacaine NA In supine position, abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualized between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After confirmation of the sufficient spread of the 10ml of 0.25% bupivacaine will be administered. 52
Experimental Group Localwound infiltration 15 ml of 0.25% bupivacaine. NA After the end of the surgery, before skin closure, the surgeon will infiltrate the surgical field using 15 ml of 0.25% bupivacaine. 52
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I and II patients who will undergo elective inguinal hernia surgery under spinal anesthesia will be included in the study. Body mass index ≥40 kg/m2 patients scheduled for bilateral or recurrent inguinal hernia repair Poorly regulated systemic disease (poorly controlled diabetes or hypertension, severe coronary artery disease, end-stage renal disease), neuromuscular diseases Patients with hypersensitivity to local aesthetic drugs will be excluded from the study Adult: 19 Year-44 Year,Aged: 65+ Year(s),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 01/12/2023 Dilla university College of health sciences Institutional review board
Ethics Committee Address
Street address City Postal code Country
Dilla Dilla 419 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain severity (measured by NRS score at rest and coughing/movement) at different points in 48 hours
Secondary Outcome Time to first analgesic request, Total postoperative Analgesic consumption at different points in 48 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dilla University Teaching Hospital Dilla Dilla Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dilla University Dilla Dilla Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dilla University Dilla Dilla Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abebayehu Zemedkun Mekonen Abebayehuzemedkun@du.edu.et +251900053426 Dilla
City Postal code Country Position/Affiliation
Dilla Ethiopia Dilla University college of health sciences and medicine departments of anesthesiology
Role Name Email Phone Street address
Public Enquiries Hailemarimam Getachew Tesema haiilemariamgetachew23@gmail.com +251912982067 Dilla
City Postal code Country Position/Affiliation
Dilla Ethiopia Research and postgraduate vice director at Dilla University college of health sciences and medicine
Role Name Email Phone Street address
Scientific Enquiries Semagn Mekonen semmek17@gmail.com +25913864605 Dilla
City Postal code Country Position/Affiliation
Dilla Ethiopia Senior researcher and assistant professor of anesthsiology at Dilla University college of health sciences and medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared Analytic Code,Clinical Study Report,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Anyone who wishes to access the data
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