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.: PACTR202203717131021 Date of Approval: 03/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title To evaluate the effect of addition dexamethasone to bupivacaine on total narcotics consumption .
Official scientific title Evaluation of Postoperative Analgesic Effect of To evaluate the effect of addition dexamethasone to bupivacaine on total narcotics consumption .
Brief summary describing the background and objectives of the trial Various adjuvants have been used to increase quality and prolong the local anesthetic effect as fentanyl, clonidine, buprenorphine, dexamethasone and others. Dexamethasone, a high-potency, long-acting glucocorticoid, has been shown to prolong peripheral nerve blockade. Dexamethasone binds to glucocorticoid receptors and inhibits potassium conductance, which decreases nociceptive C-fiber activity. It may also extend the duration of analgesia via local vasoconstriction and systemic anti-inflammatory effects To evaluate the postoperative analgesic effect of dexamethasone addition to bupivacaine with bilateral ultrasound guided subcostal transversus abdominis plane (TAP) block for major upper abdominal surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DEXA TAB
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 01/09/2021
Actual trial start date 01/09/2021
Anticipated date of last follow up 01/09/2022
Actual Last follow-up date 01/09/2022
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Recruiting
Publication URL analgesia and pain manegement
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 local anasthetic group receive 20 ml 0.25% Bupivacaine+ 2 ml normal saline in both sides ultrasound guided 24hours receive 20 ml 0.25% Bupivacaine+ 2 ml normal saline in both sides ultrasound guided 20 Placebo
Experimental Group dexamethasone and local group will receive 20 ml 0.25% Bupivacaine + 8 mg (2 ml) dexamethasone in both sides ultrasound guided 24 hour will receive 20 ml 0.25% Bupivacaine + 8 mg (2 ml) dexamethasone in both sides ultrasound guided 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. ASA Class I- II randomized 2. Patients aged ≥18 to ≤ 60 years of both sexes. 3. Patients undergoing elective upper major abdominal surgery : hepatectomy, splenectomy, common bile duct exploration, Whipple and others. 1. Body mass index (BMI) ≥35 kg/m2 or ≤15 kg/m2. 2. History of relevant drug allergy. 3. History of alcohol or analgesics dependence. 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 01/09/2021 Menoufia University ithecal committee
Ethics Committee Address
Street address City Postal code Country
yassen abdelghafar shibin elkoom 23456 Egypt
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 01/02/2022 institution review board national liver institute
Ethics Committee Address
Street address City Postal code Country
yassen abdelghafar sheben elkoom 23456 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the effect of addition dexamethasone to bupivacaine on total narcotics consumption . during operation ,24hr postoperative
Secondary Outcome • To evaluate quality of recovery. • To evaluate timing of postoperative analgesic requirement. • To estimate visual analogue scale (VAS) postoperative. • Total consumption of non-opioid analgesia. during operation ,24hr postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national liver institute yassen abdelghafar shibin elkoom 23456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yassin abdelghafar shibin elkoom 23456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor natinal liver institute yassen abdelghafar shibin elkoom 23456 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Mohamed Ali Sultan eman.soltan93@yahoo.com 00201001378542 yassen abdelghafar
City Postal code Country Position/Affiliation
shibin elkoom 23456 Egypt resident
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 002012345678 yassen abdelghafar
City Postal code Country Position/Affiliation
shibin elkoom 23456 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries nagwa Ibrahim Mowafy nagwaibraheem85@yahoo.com 002010003456 yassen abdelghafar
City Postal code Country Position/Affiliation
shibin elkoom 23456 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we intend sharing of de-identified individual trial participant data. IPD will be shared and aim of study , methodology ,results will be shared as soon as when be available . we will publish the research in anesthesia journal Clinical Study Report,Statistical Analysis Plan,Study Protocol for 1 year methodology and results when available
URL Results Available Results Summary Result Posting Date First Journal Publication Date
journal of anathesia and analgesia 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