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.: PACTR201912565389988 Date of Approval: 17/12/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title erector spinae plane block for analgesia in pilonidal sinus surgery
Official scientific title Role of ultrasound guided sacral erector spinae plane block for postoperative analgesia in pilonidal sinus surgery
Brief summary describing the background and objectives of the trial Pilonidal sinus surgery is a common surgery associated with pain in the postoperative period. Ultrasound guided erector spinae plane block (ESPB) is a regional anesthetic technique used for postoperative pain relief.It was first described by Forero as an interfascial plane block performed at the upper thoracic level. It was later reported for use in lower thoracic and lumbar levels. The aim of the study is to evaluate the analgesic efficacy of ultrasound guided sacral erector spinae plane block in pilonidal sinus surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial acute pain management
Anticipated trial start date 15/12/2019
Actual trial start date 15/01/2020
Anticipated date of last follow up 15/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group general anesthesia 1 mcg/kg fentanyl, 1-2 mg/kg propofol, 0.5 mg/kg atracurium for induction of anesthesia isoflurane in a mixture of 50% oxygen and 50% air during the surgery after general anesthesia induction tracheal intubation will be done and maintenance of anesthesia by isoflurane in mixture of oxygen and air. at the end of the operation reversal of muscle relaxant and extubation will be done then the patients will be transferred to PACU then will be followed up in the ward 35 Placebo
Experimental Group sacral erector spinae plane block single shot sacral erector spinae plane block using 20 ml of local anesthetic(10 ml bupivacaine 0.5%, 5 ml lidocaine 2%, and 5 ml normal saline) the block will be done once after induction of anesthesia and before the skin incision in prone position and after sterilization of the skin, the ultrasound transducer will be placed on the fifth spinous process on the transverse plane.sliding the probe caudally to visualise the first and second median sacral crest. the probe will then be placed 3-4 cm lateral to the second medial sacral crest. in the interfascial plane local anesthetic will be injected between the erector spinae muscles and intermediate sacral crest. the same will be repeated in the other side 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
seventy patients aged 20-60 years old both sex ASA class I and II eligible for pilonidal sinus surgery patient's refusal pre-existing neurological or psychiatric illness mental retardation BMI >35 kg/m2 Allergy to local anesthetics Infection at the injection site Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 01/11/2019 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Elgeish St Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain score on arrival to PACU then 1,2,4,6,12,and 24 hours postoperative
Secondary Outcome total fentanyl consumption intraoperative
Secondary Outcome the time to first analgesic request 24-hours postoperative
Secondary Outcome complications e.g. local anesthetic toxicity, nausea, or vomiting 24-hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Facualty of Medicine Elgeish st Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Mona Elghamry Dr Mohammad Ali and Dr Shimaa Mostafa Elgeish st Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Mona Elghamry Elgeish st Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mohammad Ali Abduallah Elgeish st Tanta 31527 Egypt
Mona Raafat Elghamry Elgeish st Tanta 31527 Egypt
Shimaa Mostafa Elrahwan Elgeish st Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona Elghamry drmonagh19802000@gmail.com +201060101867 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Mohammad Abduallah Moh_aly_2005@hotmail.com +201099957971 Elgeish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Shimaa Elrahwan Shimaa.mostafa911@yahoo.com +201007186300 Elgeish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes statistics of age ,sex,BMI, duration of surgery intraoperative opioid consumption,pain score, time of first analgesic request, complications 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 scientific research only up on e-mail 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