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.: PACTR202306801227223 Date of Approval: 26/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title perioperative Analgesic Effect of Erector Spinae Plane Blocks in Whipple Surgery.
Official scientific title Evaluation of perioperative Analgesic Effect of Erector Spinae Plane Blocks in Whipple Surgery :a Randomized Controlled Study
Brief summary describing the background and objectives of the trial Hepatopancreaticobiliary (HPB) surgery is a major upper abdominal surgery with major hemodynamic changes The standard analgesic regime for major HPB surgery includes thoracic epidural analgesia (TEA), rectus sheath, and subcostal transversus abdominal plane (TAP) blocks with surgically sited TAP catheters at the end of surgery, analgesic adjuncts including paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs) when appropriate, and fentanyl-based patient-controlled analgesia (PCA) starting postoperative day.The most recently described alternative to TEA is the erector spinae plane (ESP) block. The ESP block is a facial plane block that aims to inject a local anesthetic agent within a plane beneath the erector spinae muscle AIM :To study the impact of ESP Block on hemodynamic stability and maintenance of intra-operative Analgesia Nociception Index (ANI) accepted range and evaluate the postoperative pain by visual analogue score (VAS), total opioid requirements and incidence of post-operative
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ESP vs TEP
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/03/2023
Actual trial start date 04/03/2023
Anticipated date of last follow up 01/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL IN anasthesia and analgesia journals and pain manegement journals
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group erector spinae block 20ml bupivacaine 0.25%) 10ml bupivacaine 0.25% on each side every 6h. The skin will be prepared with 2% chlorhexidine, ultrasound probe 5–10 MHz (SonoSite Edge, Bothell, Washington) will be placed in transverse orientation to identify the right lateral tip of the T7 transverse process corresponding to inferior angle of scapula. The transducer then rotated 90 degrees into a longitudinal parasagittal over the transverse process (T7-8).[11] Erector spinae muscles will be identified superficial to the acoustic shadow of the transverse processes. A local anesthetic (xylocaine20mg) will be injected at the target area. A 17-gauge Tuohy needle (B. Braun, Shanghai, China) will be inserted in a cephalad-to-caudal direction until the tip reach transverse process .Saline fluid( 0.5-1ml) will be injected to confirm correct position then local anesthetic will be injected (20ml bupivacaine 0.25%) ,and then thread the epidural catheter to where the 20 cm mark reaches the needle hub. After removal of the needle, the catheter will be withdrawn to leave roughly 4 to 6 cm in the space and then will be fixed safely to the back of the patient. Then the whole procedure repeated on the other side. 25
Control Group thoracic epidural 10ml bupivacaine 0.25% 10ml Bupivacaine 0.25% every 4h. TE catheter will be inserted upon arrival to the operation room (OR) before induction of anesthesia and with the patient in sitting position after giving anxiolytic midazolam 2mg IV. The target level (T9-10) skin will be prepared with 2% chlorhexidine then a local anesthetic (xylocaine 20mg) will be injected. The epidural needle is then introduced with the needle bevel pointed cephalad, upon loss of resistance (advances from the ligamentum flavum into the epidural space), syringe will be removed and the epidural catheter will be threaded. After catheter placement, the needle can be removed with careful attention then the catheter can be withdrawn to leave roughly 4 cm to 6 cm in the epidural space and carefully fixed to the back of the patient 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients aged 18 to 65 years of both sexes candidate for Whipple operation and classified by American Society of Anesthesiologists (ASA) II and III with Body-mass index of less than 40 kg/m². - Pre-existing significant cardiac dysfunction, respiratory, renal or cerebrovascular diseases. - Patients allergic to any of the study drugs, with opioid addiction or alcohol abuse. - Body-mass index higher than 40 kg/m². - Contraindications for neuroaxial block (e.g. Coagulopathy). - Patients unwilling to participate in the study Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 01/03/2023 institutional review board
Ethics Committee Address
Street address City Postal code Country
yaseen abdelghafar shebeen elkoom 23456 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To study the impact of ESP Block on hemodynamic stability and maintenance of intra-operative Analgesia Nociception Index (ANI) accepted range. Base line before induction of anesthesia ,Before skin incision ,After skin incision ,At 2h, 4h from start of surgery and at the end of surgery with final skin stitches .
Secondary Outcome To evaluate the postoperative pain by visual analogue score (VAS), total opioid requirements and incidence of post-operative complications (as measured by the comprehensive complication index (CCI)) within 48 hours. After transportation and stabilization in the ICU, 2h, 6h, 12h, 24h, 36h and 48h post recovery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NAtional liver institute yassen abdelghafa street shebeen elkom 23456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yaseen abdelghafar shebeen elkom 23456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor natioanl liver institute yassen abdelghafar shebeen elkoom 23456 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Menattallah Aly El Shafie yaseen abdelghafar shebeen elkoom 23456 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed othman othmanshow@yahoo.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt assisstant lecturer of anasthesia
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt lecturer of anasthesia
Role Name Email Phone Street address
Scientific Enquiries Menattallah El Shafie menna80mas@gmail.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt lecturer of anasthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we intend sharing study protocol , aim of the work, patient and method and the results when be available.sharing of de-identified individual trial participant data. effect of ES on pain manegement and patient haemodynamics Study Protocol when the result willbe available study protocol
URL Results Available Results Summary Result Posting Date First Journal Publication Date
international anasthesia journal 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