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.: PACTR201906524333727 Date of Approval: 19/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dexamethasone analgesic effect in pectoral nerve block for mastectomy
Official scientific title Dexamethasone as an adjuvant analgesic in pectoral nerve block for mastectomy: a randomized controlled trial
Brief summary describing the background and objectives of the trial Acute postmastectomy pain is an integral risk factor for the development of its chronicity.40% of patients will have severe acute postmastectomy pain, and 50% will develop chronic post-operative pain with impaired life quality. Appropriateness of perioperative analgesic techniques in modified radical mastectomy is always questionable. Blanco et al at 2012, described interfascial plane block by deposition of local anesthetic between the two pectoralis (major and minor) muscles (PECS I) and deposition of local anesthetic between the serratus anterior and pectoralis minor muscles (PECS II). local anesthetic can be mixed with adjuvant drugs to prolong analgesia from nerve blocks.one of these adjuvants is dexamethasone.1ry objective is to compare the total postoperative morphine consumption over 48 hours.2ry objectives were postoperative visual analogue scale scores, perioperative hemodynamics, duration of hospital stay, and incidence of complications and morphine-related side effects.
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 01/07/2019
Actual trial start date
Anticipated date of last follow up 01/01/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants)
Recruitment status 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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group 1 dexamethasone 28ml bupivacaine 0.25 % plus 2ml(8mg) dexamethasone once Patients will be premedicated with 2-5 mg midazolam intravenously 10 min preoperatively through a 20-gauge cannula. standard monitors will be attached. patients will receive general anesthesia(Pre-oxygenation with 100% oxygen for 3 min, Induction of anesthesia will be done with intravenous fentanyl 1 μg/kg and propofol 2 mg/kg and Atracurium 0.5 mg/kg. Anesthesia will be maintained by 1 MAC of isoflurane. Ventilation will be maintained by 50% oxygen in air and minute volume was set to maintain end-tidal CO2 at 30–35 mm Hg. then ultrasound-guided pectoral nerve block by bupivacaine 0.25 % plus 8mg dexamethasone (28ml bupivacaine 0.25 % plus 2ml dexamethasone) before the surgical procedure. The ultrasound high-frequency linear array sterile probe will be placed at infraclavicular region after skin sterilization and moved laterally to locate the axillary artery and vein directly above 1st rib where pectoralis major and pectoralis minor muscles are identified at this US window, an echogenic needle will be advanced, in-plane, 20 ml of the prepared solution is injected between serratus anterior and pectoralis minor muscles. The needle was then withdrawn and an additional last 10 ml of the solution was deposited between the two pectoral muscles.IV fentanyl 0.5 µg/kg will be administered if intra-operative hemodynamic parameters increased by ≥ 20% relative to baseline values.at the end of surgery IM 75 mg of diclofenac potassium and IV, Ondansetron 4 mg will be given once. if the postoperative VAS score was 3 or greater, a loading dose of 5 mg of morphine will be administered through slow IV route. Then, a PCA will be started( loaded with 1 mg/mL of morphine and set to deliver on-demand bolus doses of 2 mL with a 5- minute lockout period, No background infusion will be allowed). 27
Control Group group 2 control 28ml bupivacaine 0.25 % plus 2ml normal saline once Patients will be premedicated with 2-5 mg midazolam intravenously 10 min preoperatively through a 20-gauge cannula. standard monitors will be attached. patients will receive general anesthesia(Pre-oxygenation with 100% oxygen for 3 min, Induction of anesthesia will be done with intravenous fentanyl 1 μg/kg and propofol 2 mg/kg and Atracurium 0.5 mg/kg. Anesthesia will be maintained by 1 MAC of isoflurane. Ventilation will be maintained by 50% oxygen in air and minute volume was set to maintain end-tidal CO2 at 30–35 mm Hg. then ultrasound-guided pectoral nerve block by bupivacaine 0.25 % plus 8mg dexamethasone (28ml bupivacaine 0.25 % plus 2ml normal saline) before the surgical procedure. The ultrasound high-frequency linear array sterile probe will be placed at infraclavicular region after skin sterilization and moved laterally to locate the axillary artery and vein directly above 1st rib where pectoralis major and pectoralis minor muscles are identified at this US window, an echogenic needle will be advanced, in-plane, 20 ml of the prepared solution is injected between serratus anterior and pectoralis minor muscles. The needle was then withdrawn and an additional last 10 ml of the solution was deposited between the two pectoral muscles.IV fentanyl 0.5 µg/kg will be administered if intra-operative hemodynamic parameters increased by ≥ 20% relative to baseline values.at the end of surgery IM 75 mg of diclofenac potassium and IV, Ondansetron 4 mg will be given once. if the postoperative VAS score was 3 or greater, a loading dose of 5 mg of morphine will be administered through slow IV route. Then, a PCA will be started( loaded with 1 mg/mL of morphine and set to deliver on-demand bolus doses of 2 mL with a 5- minute lockout period, No background infusion will be allowed). 27 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled for elective unilateral modified radical mastectomy age from 18 to 60 years ASA class I OR II -Patients with contraindication to pectoral nerve block e.g. (allergy from bupivacaine - skin infection at the site of injection - coagulopathy) - Patients received chemotherapy or radiotherapy. - Patients complaining from any psychotic. -Pregnant or lactating mothers. -History of drug dependency or substance addiction. -Patients complaining of chronic pain or on regular analgesic medication. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Female
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 12/03/2018 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
kilo 4,5 ,the ring road ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome total postoperative morphine consumption over 48 hours after 48 hours of intervention
Secondary Outcome postoperative VAS pain score at rest and on movement 0, 3, 6, 9, 12, 24,36 and 48 postoperative hours
Secondary Outcome the time of first postoperative request of analgesia postoperative
Secondary Outcome hemodynamics systolic blood pressure, diastolic blood pressure, mean blood pressure, heart rate intraoperative at base line,at skin incisin then every 15 min till the end of surgery,postoperative at 0, 3, 6, 9, 12, 24,36 and 48 hours
Secondary Outcome intraoperative fentanyl consumption during surgery
Secondary Outcome Ramsay sedation scale 0, 3, 6, 9, 12, 24,36 and 48 postoperative hours
Secondary Outcome postoperative nausea and vomiting 0, 3, 6, 9, 12, 24,36 and 48 postoperative hours
Secondary Outcome postsurgical hospital stay postoperative
Secondary Outcome postoperative complications postoperative till 48 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university hospital kilo 4,5,the ring road ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed abuelnaga ard elgameiat elsheik zayed ismailia 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor suez canal university hospital kilo 4,5 the ring road ismailia 41522 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
hamdy ali hendawy hoda sharawy street ismailia 41522 Egypt
mohamed elsayed ibrahim ard elgameiat ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hamdy hendawy hamdy.hendawy@med.suez.edu.eg 00201143667734 hoda sharawy
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia intensive care and pain management at faculty of medicine suez canal university
Role Name Email Phone Street address
Scientific Enquiries mohamed abuelnaga Mohamed_abuelnga@med.suez.edu.eg 00201004150671 ard elgameiat
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia intensive care and pain management at faculty of medicine suez canal university
Role Name Email Phone Street address
Public Enquiries hamdy hendawy hamdy.hendawy@med.suez.edu.eg 00201143667734 hoda sharawy
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia intensive care and pain management at faculty of medicine suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes participant data collected during the study after deidentification Statistical Analysis Plan,Study Protocol beginning 9 months and ending 36 months after the article publication researchers who provide a methodologically sound proposal
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