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.: PACTR201911712319290 Date of Approval: 12/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Opioid sparing anesthesia for bariatric surgery
Official scientific title Perioperative opioid sparing effect of erector spinae plane block and intravenous dexmedetomidine for patients with obstructive sleep apnea undergoing bariatric surgery
Brief summary describing the background and objectives of the trial Obese patients are particularly sensitive to the sedative and respiratory depressive effects of long acting opioids. Many obese patients also have obstructive sleep apnoea syndrome (OSAS) and will be prone to airway obstruction and desaturation in the postoperative period.Dexmedetomidine is a short acting, highly potent, selective α2 adrenoceptor agonist with unique analgesic, sedative, amnesic and anaesthesia-sparing properties.Erector spinae plane block could result in both visceral and somatic abdominal analgesia if the injection is performed at a lower thoracic level.The aim of this study is to evaluate the opioid sparing effect of erector spinae plane block and intravenous dexmedetomidine in patients undergoing laparoscopic bariatric surgeries
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial acute pain management
Anticipated trial start date 15/11/2019
Actual trial start date
Anticipated date of last follow up 15/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group erector spinae plane block and intravenous dexmedetomidine bilateral single shot erector spinae plane block preoperative and intravenous dexmedetomidine infusion intraoperative 1 mcg/kg bolus dose in 10 min then 0.25 mcg/kg/h erector spinae plane block preoperative and dexmedetomidine intravenous continous infusion intraoperative erector spinae plane block will be performed preoperative in a sitting position, a low-frequency curved ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the right T7 spinous process. A 22 gauge, 100-mm, blunt needle (B. Braun Medical Inc., Bethlehem, PA) will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep aspect of erector spinae muscle. Anatomical landmarks will be identified, and the location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. Twenty ml 0.25% bupivacaine will be injected under direct vision. intravenous dexmedetomidine will be given as described above intraoperative general anesthesia will be conducted as the control group 20
Control Group general anesthesia only sham block will be performed preoperative then general anesthesia will be conducted for the surgery the laparoscopic surgery will be performed under general anesthesia sham block will be performed preoperative General anesthesia will be induced in both groups by administering O2 via a facemask, propofol 1.5 mg/kg with lidocaine 1.5 mg/kg intravenous till loss of consciousness, and rocuronium 0.9 mg/kg or succinylcholine 1mg/kg when appropriate. Fentanyl 2 mcg/kg intravenous will be given in control group only. intravenous infusion of normal saline intraoperative. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
fourty patients aged 20-55 years old both sex body mass index at least 35 kg/m2 ASA II with obstructive sleep apnea (use nocturnal CPAP ventilation regularly) eligible for elective laparoscopic bariatric surgery patient refusal lactating female use of opioid for chronic pain or drug abuse allergy or contraindication to any of the used drugs uncontrolled diabetes mellitus or hypertension unstable cardiopulmonary dysfunction, renal or hepatic insufficiency, Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 55 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 01/08/2019 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
El-Geish st Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative opioid requirements 24 hours postoperative
Secondary Outcome number of patients need extra fentanyl consumption other than that of induction of anesthesia intraoperative
Secondary Outcome heart rate baseline, after end of bolus dose of the infused drug , immediately after intubation,at skin incision,every 5 min for 15 min then every 15 min
Secondary Outcome mean arterial blood pressure baseline, after bolus dose of the infused drug , immediately after intubation,at skin incision,every 5 min for 15 min then every 15 min
Secondary Outcome pain score arrival in PACU, then 30 min, 2 ,4,8,12,16,20,24 hour postoperative.
Secondary Outcome recovery time from discontinuation of inhalational anesthetic and reversal of muscle relaxant until spontaneous eye opening and obeying commands.
Secondary Outcome adverse effects 24 hours postoperative
Secondary Outcome time to first analgesic request postoperative 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Faculty of Medicine El-Geish st Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Mona Eelghamry and Dr Atteia Anwar Elgeish st Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Mona Raafat El Ghamry Elgeish st Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Atteia Gad Anwar Elgeish st Tanta 31527 Egypt
Dr Mona Raafat El Ghamry Elgeish st Tanta 31527 Egypt
Shaimaa Waheed Zahra Elgeish st Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona El Ghamry drmonagh19802000@gmail.com +201060101867 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Mona El Ghamry drmonagh19802000@gmail.com +201060101867 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Atteia Anwar atteiagad@gmail.com +201025547544 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes statistics of age ,sex,BMI, duration of surgery intra and postoperative opioid consumption, intraoperative sevoflurane consumption, pain score, recovery time, haemodynamic and adverse effects Statistical Analysis Plan IPD will be shared after finishing and publication of the study.and it will be available for 1 year. the IPD will be available for every one up on e-mail request with reason of the request. request will be sent to e-mail of principal investigator drmonagh19802000@gmail.com
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