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.: PACTR202201724349197 Date of Approval: 17/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ERECTOR SPINAE PLANE BLOC FOR ANALGESIA IN PATIENTS UNDERGOING OPEN RENAL SURGERY
Official scientific title ERECTOR SPINAE PLANE BLOC FOR ANALGESIA IN PATIENTS UNDERGOING OPEN RENAL SURGERY : A double-blind randomized controlled trial
Brief summary describing the background and objectives of the trial Open renal surgery (OPRS) has always many indications.Unfortunately, OPRS leads to an intense postoperative pain. Patient Auto Controlled Analgesia is largely used in this context but insufficient. So, many loco regional techniques have been used: Epidural Analgesia, Quadratus Lumborum Block, Transverse Abdominis Block, Paravertebral Bloc. Erector Spinae Plane Bloc (ESPB), a novel technique recently described by Forero et al have been tested in many surgeries with promising results. ESPB has been tested in a few case reports in OPRS. Thus, we wanted to assess analgesic effect of ESPB in patients undergoing OPRS in a randomized double blind randomized trial. The objective of this study is to compare verbal numerical rating scale pain score between Group P with PCA only and Group E with ESPB associated to PCA. The secondary outcomes are variation of hemodynamic parameters after incision, total opiod preoperative consumption, total opioid postoperative consumption, opioid side effects.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 09/01/2022
Actual trial start date
Anticipated date of last follow up 31/03/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 54
Recruitment status Active, not 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 Allocation was determined by the holder of the sequence who is situated off site 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 Ultrasound Guided Erector Spinae Plane Bloc after general anesthesia befor incision 30ml Ropivacaine 0.2%, one time, no continus infusion between15 and 30 minutes We perform an Erector spinae plane bloc in interventional group. this bloc consist in injection of 30 Ml of ropivacaine 0.2% deep to erector spinae muscle, after ultrasound repairing. test of aspiration is performed before injection. Local anesthetic spread is verified after injection. In the end of surgical procedure, after morphine titration, a patient autocontrolled analgesia is installed.1ml = 1 mg Morphine, no continuous basal, lockout = 10 minutes 27
Control Group Patient Auto Controlled Analgesia In the end of surgical procedure, after morphine titration, a patient autocontrolled analgesia is installed.1ml = 1 mg Morphine, no continuous basal, lockout = 10 minutes 24 hours Intravenous PCA is intalled in the end of surgery after morphine titration. 27 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults undergoing open renal surgery with american society score I or II and a body mass index < 30 Drug Use, preoperative analgesic drugs use, psychiatric disease Adult: 19 Year-44 Year 18 Year(s) 80 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
No 29/12/2021 Comite de Protection des Personnes Sud
Ethics Committee Address
Street address City Postal code Country
Road Menzel Chaker Kilometer 0.5 Sfax 3003 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Verbal numerical rating scale pain score at 1, 2, 6, 12 and 24 hours 1, 2, 6, 12 and 24 hours
Secondary Outcome variation of hemodynamic parameters after incision 5 minutes after incision
Secondary Outcome Total peroperative opioid consumption In the end of surgery
Secondary Outcome Postoperative total Opioid consuption In the end of surgical procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Habib Bourguiba University Hospital Road el Ain Kilometer 0.5 SFAX 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Habib Bourguiba University Hospital Road EL Ain Kilometer 0.5 Sfax 3000 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hichem Kolsi hichem.kolsi17@gmail.com 0021693502153 Road Lafrane kilometer 5.5
City Postal code Country Position/Affiliation
SFAX Tunisia Habib Bourguiba University Hospital
Role Name Email Phone Street address
Scientific Enquiries Rahma Derbel rahma.derbel@yahoo.com 0021644203125 Road Gremda Kilometer 4
City Postal code Country Position/Affiliation
Sfax Tunisia Habib Bourguiba University Hospital
Role Name Email Phone Street address
Public Enquiries Mariem Keskes mariemkeskesabid@gmail.com 0021655909404 Road Menzel Chaker kilometer 10
City Postal code Country Position/Affiliation
Sfax Tunisia Habib Bourguiba University Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data will be available. All of the individual participant data collected during the trial will be shared after deidentification. I will provide the additional documents cited below in addition to spss file. The IPD sharing time will be few weeks after publication. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months later Controlled access Criteria for reviewing access : Anesthesiologist, Urologist ...
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