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.: PACTR202404639537768 Date of Approval: 23/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of dexamedetomidine versus magnesium sulphate as an adjuvant to bupivacaine in subcostal transverses abdominis plane block on the quality of recovery following laparoscopic cholecystectomy
Official scientific title Efficacy of dexamedetomidine versus magnesium sulphate as an adjuvant to bupivacaine in subcostal transverses abdominis plane block on the quality of recovery following laparoscopic cholecystectomy
Brief summary describing the background and objectives of the trial Laparoscopic cholecystectomy is the mainstay treatment of chronic calcular cholecystitis. Pain continues to be an important issue after laparoscopic cholecystectomy resulting in prolonged admissions or re- admissions . Pain after laparoscopic cholecystectomy is a merge (combination) of three different components: somatic(incisional) pain due to trocar insertion sites, visceral(deep intra-abdominal) pain and referred visceral(shoulder) pain . The TAP block involves blocking the abdominal wall's sensory innervation, which arises fromthe anteriordivision of the thoraco-lumbar spinal nerves. These sensory nerves are in the plane between the internal oblique and transverse abdominis muscles.The present study aims to investigate whether combined dexmedetomidine-bupivacaine or magnesium sulphate –bupivacaine in ultra-sound guidedbilateral oblique subcostal TAP block will be effective in improving Quality of recovery after anesthesia after laparoscopic cholecystectomy.
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 Pain control
Anticipated trial start date 01/01/2023
Actual trial start date 02/09/2023
Anticipated date of last follow up 08/12/2023
Actual Last follow-up date 01/01/2024
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
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 from a statistics book Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bilateral subcostal transverses abdominis plane block 20 ml.of 0.25% bupivacaine with the addition of 1ug/kg of dexmedetomidine to be diluted with saline to a volume of2 ml. (22 ml. each side) 2 minutes Initially, the probe is placed transversely in the midline of the anterior abdominal wall just below thexiphoid process with thepatientin the supine position. Linea alba is easily identified in the center, in betweenthe two recti abdominis muscles.The probeis moved laterallyto identify the lateral border of rectus abdominis muscle, linea semilunaris, external and internal oblique muscles, and transversus abdominis muscle. A 21-G needle will be inserted 2 to 3 cm. medial to the probe, in medial to lateral direction in-plane to the probe, till it reaches the TAP plane between the rectus abdominis and transversus abdominis muscles (subcostal approach). The local anesthetic solution is deposited here after confirming the needle tip position with hydro dissection to distend the subcostal TAP plane 30
Experimental Group bilateral subcostal Transverse abdominis plane block 20 ml. of 0.25% bupivacaine with the addition of 2 ml. isotonic saline (22 ml. each side). 2minutes Initially, the probe is placed transversely in the midline of the anterior abdominal wall just below thexiphoid process with thepatientin the supine position. Linea alba is easily identified in the center, in betweenthe two recti abdominis muscles.The probeis moved laterallyto identify the lateral border of rectus abdominis muscle, linea semilunaris, external and internal oblique muscles, and transversus abdominis muscle. A 21-G needle will be inserted 2 to 3 cm. medial to the probe, in medial to lateral direction in-plane to the probe, till it reaches the TAP plane between the rectus abdominis and transversus abdominis muscles (subcostal approach). The local anesthetic solution is deposited here after confirming the needle tip position with hydro dissection to distend the subcostal TAP 30
Control Group Bilateral subcostal transverses abdominis plane block 20 ml. of 0.25% bupivacaine with the addition of 2 ml. isotonic saline (22 ml. each side). 2 minutes Initially, the probe is placed transversely in the midline of the anterior abdominal wall just below thexiphoid process with thepatientin the supine position. Linea alba is easily identified in the center, in betweenthe two recti abdominis muscles.The probeis moved laterallyto identify the lateral border of rectus abdominis muscle, linea semilunaris, external and internal oblique muscles, and transversus abdominis muscle 30 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled for laparoscopic cholecystectomy surgery.  American Society of Anesthesiologists(ASA)I-II.  Both genders.  Age:18-60years Patients' refusal to participate in the study.  Body Mass Index(BMI)>40Kg/m2  Infection at site of needle insertion.  Hypersensitivity to the studied drugs.  Psychotic disorders.  Bleeding Disorders.  Chronic renal or hepatic disease.  Conversion to open cholecystectomy Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 30/04/2023 Mansoura Faculty of Medicine Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
Geish street mansoura Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Visual Analogue Scale (VAS): scored from 0-10 (where 0= no pain, and 10= the worst pain imaginable 2hours /4hours/ 6hours /12hours /24hours post operative
Primary Outcome Quality of recovery post anesthesia as physical and mental well- being according toquality of recovery – 40 24 hours post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gastro enterology centre gehan elsaddat street mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mansoura university hospitals Gehan el saddat mansoura mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Gastroenterology centre mansoura university gehan elsaddat mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled eslam gamalk432@gmail.com 01064508120 old Souq street
City Postal code Country Position/Affiliation
mansoura Egypt Resident doctor
Role Name Email Phone Street address
Public Enquiries Ola abd eldayem Dr.ola_Taha@hotmail.com +201202811110 geish street
City Postal code Country Position/Affiliation
mansoura Egypt Professor of anaesthesia
Role Name Email Phone Street address
Scientific Enquiries hatem saber dr.hatem_saber@hotmail.com +201005257062 toril
City Postal code Country Position/Affiliation
mansoura Egypt Proffessor of anaesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified individual participant data that underlie the result reported in this article will be shared beginning 9months following publication with investigators whose proposed useof the data has been approved by Institutional Review Board (IRB), Independant Ethics Committee (IEC) or Researh Ethics Board (REB) . Data will be available through contacting the following email address gamalkk432@gmail.com Study Protocol Within 12 months of study completion patients undergoing laproscopic cholecystectomy
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