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.: PACTR202301487176282 Date of Approval: 16/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study between Bupivacaine versus Bupivacaine with Dexmedetomidine in Ultrasound Guided Transversus Abdominis Plane Block as Postoperative Analgesia In Open Inguinal Hernia
Official scientific title Comparative Study between Bupivacaine versus Bupivacaine with Dexmedetomidine in Ultrasound Guided Transversus Abdominis Plane Block as Postoperative Analgesia In Open Inguinal Hernia
Brief summary describing the background and objectives of the trial postoperative pain leads to chronic pain and undesirable events ranging from patient discomfort and prolonged immobility to pulmonary complication . Expected pain prevalence following hernia repair was determined as 54%. Transversus abdominal plane block is one of the peripheral nerve blocks which was reported to reduce postoperative pain following hysterectomy, colorectal surgery, appendectomy, and inguinal hernia repair . transversus abdominis plane is located between the oblique muscles and the transversus abdominis muscles. Transversus abdominis plane block basically involves deposition of local anesthetic in the plane between the internal oblique and transversus abdominis muscles to target the nerves passing through, that originate from thoracic level T6-T10 . Dexmedetomidine is a selective alpha-2 adrenergic agonist with both analgesic and sedative properties, When administered as perineural adjuvant; it reduces initial blocking time also prolonging sensory and motor blockade duration. the objective of this study is to compare between Bupivacaine versus Bupivacaine with Dexmedetomidine in Ultrasound Guided Transversus Abdominis Plane Block as regardes efficacy, complications, quality and duration of postoperative analgesia.
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: Drugs
Anticipated trial start date 25/08/2021
Actual trial start date 27/08/2021
Anticipated date of last follow up 27/08/2022
Actual Last follow-up date 30/08/2022
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 52
Recruitment status Recruiting
Publication URL Issuing authority/Trial register
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 Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block as Postoperative Analgesia In 20 ml of bupivacaine hydrochloride 0.25% and 1ml normal saline after the end of operation and before the start of extubation , the block will be performed After sterilization of skin, probe will be inserted transversely just below the xiphoid process and locate the pair rectus abdominis and linea alba, rotate the probe obliquely and laterally until aponeurosis of linea semilunaris appears. Internal oblique and external oblique are located lateral to the linea semilunaris. Identify the muscles at mid axillary line between costal margin and iliac crest, after measuring the depth of TAP, a needle will be inserted in plane from medial to lateral with regular aspiration till the plane between the internal oblique and transversus abdominis muscles is hydro dissected until an elliptical hypoechoic spread of local anesthetic between these two muscles will be recorded. 26 Placebo
Experimental Group Bupivacaine with Dexmedetomidine in Ultrasound Guided Transversus Abdominis Plane Block as Postopera 20 ml of bupivacaine hydrochloride 0.25% and 100 μg dexmedetomidine after the end of operation and before the start of extubation , the block will be performed After sterilization of skin, probe will be inserted transversely just below the xiphoid process and locate the pair rectus abdominis and linea alba, rotate the probe obliquely and laterally until aponeurosis of linea semilunaris appears. Internal oblique and external oblique are located lateral to the linea semilunaris. Identify the muscles at mid axillary line between costal margin and iliac crest, after measuring the depth of TAP, a needle will be inserted in plane from medial to lateral with regular aspiration till the plane between the internal oblique and transversus abdominis muscles is hydro dissected until an elliptical hypoechoic spread of local anesthetic between these two muscles will be recorded. 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients aged between 30 – 60 years old. - Physical Status: ASA I - III patient. - Refusal of procedure or participation in the study. - Patient under age of 30 years old or above 60 years old. - Body weight less than 60 kg or above 100 kg. - Pregnancy or lactation. - Infection at site of injection. - CNS Diseases like (epilepsy, stroke …etc.) or neurological disease affecting patient’s lower limb. - History or evidence of coagulopathy. - Difficult visualization of the anatomy. Middle Aged: 45 Year(s)-64 Year(s) 30 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 15/06/2021 research Ethics committee at the faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
38 abbassia ,next to the Al- Nour mosque cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ● VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively at 30 min and 2, 4, 6, 12, and 24 h postoperative
Secondary Outcome ● Duration of postoperative analgesia (the time from recovery to the first given dose of Nalbuphine ) . ● The total dose of nalbuphine used postoperatively. ● Number of patients who will need rescue analgesia 30 min and 2, 4, 6, 12, and 24 h postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine Ain shams university 38 abbassia square , next to AL-Nour Mosque , cairo egypt cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
hadeer ahmed galal 18 rashidy street kasr el ainy cairo 1181 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine ain shams university 38 abbassia , next to the AL- NOUR mosque cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
hadeer ahmed galal 18 rashidy street kasr el ainy cairo 1181 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries hadeer fadoul hadeergalal79@gmail.com 01281504039 18 Rashidy street kasr el ainy
City Postal code Country Position/Affiliation
cairo 1181 Egypt assistant lecture department of anesthesia faculty of medicine Ain shams university
Role Name Email Phone Street address
Scientific Enquiries maha sadek mahasadek81@yahoo.com 01144866675 Nasr city
City Postal code Country Position/Affiliation
cairo 1181 Egypt professor of anesthesia faculty of medicin Ain shams university
Role Name Email Phone Street address
Principal Investigator ihab gad Ihabgad85@med.asu.edu.eg 01007071823 masr el gededa
City Postal code Country Position/Affiliation
cairo 1181 Egypt lecturer of anesthesia faculty of medicine Ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of individual participant data collected during the trial , after deidentification Statistical Analysis Plan following publication any purpose
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