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.: PACTR202006878231703 Date of Approval: 18/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound-Guided Transmuscular Versus Anterior Subcostal Quadratus lumborum blocks Versus Thoracic Paravertebral Block For Acute Postoperative Pain Management In Open Renal Surgeries
Official scientific title Ultrasound-Guided Transmuscular Versus Anterior Subcostal Quadratus lumborum blocks Versus Thoracic Paravertebral Block For Acute Postoperative Pain Management In Open Renal Surgeries
Brief summary describing the background and objectives of the trial Pain has various physiological and psychological disturbances such as increased myocardial oxygen demand, poor ventilatory function, anxiety, sleep disturbances and psychosis. Poorly controlled acute pain can lead to chronic pain syndrome which is very distressing to the patient; therefore, control of pain is an important element in the perioperative period and requires good effort from the attending anesthesiologist. Renal surgeries are usually associated with significant postoperative pain.(1) Patients undergoing renal surgeries are usually having impaired renal function and need the judicious use of systemic analgesics. Thus, the regional nerve block can be a good alternative in such patients.(2) Ultrasound guided paravertebral block is awell established analgesic modality after thoracic and abdominal surgeries where the local anesthetic is injected in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina.(3) The quadratus lumborum (QL) block was first described by Blanco.(4) Currently, the QL block is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant and adult) undergoing abdominal surgery.(5) There are four different approaches for ultrasound guided QLB where local anesthetic is injected adjacent to the quadratus lumborum (QL) muscle from various directions. These are lateral QLB, posterior QLB, anterior (transmuscular) QLB and intramuscular QLB.(6) Transmuscular QLB and anterior subcostal QLB have been recently designed to alleviate pain in intraperitoneal and retroperitoneal surgical procedures. The mechanism of action relies on local anesthetic spread cranially towards the thoracic paravertebral space by different level of dermatomal distribution.(7) Anterior subcostal QLB has been used for analgesia following hip arthroplasty, lower abdominal surgery and nephrectomy with reported sensory loss between T8 and L2.(8) Up to date, no prospective rando
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 10/07/2020
Actual trial start date 11/08/2020
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants)
Recruitment status Not yet 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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group II Patients of this group will receive 20 ml plain bupivacaine 0.25% injected to produce LA spread anterior to the QL muscle towards the 12th rib at L1 level. 24 hours The patient will be placed in a lateral position and under complete aseptic precautions with Povidone iodine 10%,a curved (C5-1 MHz) probe of the Philip CX50 Ultrasound Scanner will be located posteriorly below the 12th rib approximately 6–8 cm from the spinous process in a parasagittal oblique plane tilted medially at L1-2 level. The QL muscle will be visualized at its point of insertion on the lower border of th 12th rib, and the latissimus dorsi (LD) muscle will be noted posteriorto the QL muscle, while the kidney, perinephric fat and fascia Will be anterior to the QL muscle and transversalis fascia. A 22 G spinal needle will be advanced in plane in the caudal-to-cranial direction under ultrasound guidance until the needle tip is positioned anterior to the QL muscle and between the investing layer of the QL muscle and the transversalis fascia (anterior layer of the thoraco lumbar fascia). After a negative aspiration, 20 mL of bupivacaine 0.25% will be injected to produce LA spread between the investing layer of the QL muscle and the transversalis fascia and cranially towards the 12th rib. A successful block will be defined as loss of sensory function in the area. 18
Control Group Group III Patients of this group will receive 20 ml plain bupivacaine 0.25% injected in the paravertebral space at T10 level. 24 hours Patients of the TPVB group will be placed in a lateral position, the spinous processes of 10th thoracic vertebra will be identified and marks will be made 2 cm lateral to the spinous processes. After sterilization of the back of the patient with Povidone iodine 10%, 3 ml Lignocaine will be injected subcutaneously 3 cm lateral to the spinous process of T10 making a wheel, a curved (C5-1 MHz) probe of the Philips CX50 will be placed transversely at the mark to identify the paravertebral space. Then a 22-G spinal needle (B. Braun, Melsungen, Germany) will be inserted in-plane in a lateral to medial direction and advanced until the tip reaches the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. Then, 20 ml of bupivacaine 0.25% will be injected into the paravertebral space of 10th thoracic vertebra. The block will be confirmed as correct by the sign of the parietal pleura being pressed down by the local anesthetic. A successful block will be defined as loss of sensory function in the area. 18 Active-Treatment of Control Group
Experimental Group Group I Patients of this group will receive 20 ml plain bupivacaine 0.25% injected between the QL muscle and psoas major muscle into the interfascial plane at L4 level. 24 hours The patient will be placed in a lateral position and under complete aseptic precautions with Povidone iodine 10%, a curved (C5-1 MHz) probe of the Philip CX50 Ultrasound Scanner will be located horizontal to the iliac crest at the posterior axillary line to find the Shamrock sign (The QL muscle is seen as a darker triangular shape attaching to the apex of tansverse process of L4, the three leaves of shamrock are composed of the QL, the psoas major and erector spinea muscles while TP constitutes the stem). The 22-G spinal needle will be inserted in plane and directed to the QL muscle. After confirmation of the proper positioning of the needle tip between the psoas major muscle and the QL muscle, 20 ml plain bupivacaine 0.25% will be injected into the interfascial plane. The effective block will be confirmed by the sign of local anesthetic spreading around the QL muscle and the loss of sensory function in the area. 18
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Aged from 21 to 65 years old  Both sex  ASA physical activity I, II  Admitted for elective open renal surgeries.  Patient refusal.  Patients who are taking analgesics for chronic illness or have history of substance abuse.  Patients who are unable to describe their postoperative pain (e.g., language barrier or neuropsychiatric disorder).  Patient with bleeding disorders.  Infection at the block injection site.  Patients with history of allergy to local anesthetics. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 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 30/11/2019 Research ethics committee
Ethics Committee Address
Street address City Postal code Country
El-Gharbia Governorate, Tanta. El-Gash st. Medical Campus The Faculty of Medicine Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assessment of pain using Visual Analogue score (VAS) first day after surgery - 24 hours
Secondary Outcome Time to first rescue analgesic demand after surgery. first day after surgery - 24 hours
Secondary Outcome Total analgesic consumption in the first day after surgery. first day after surgery - 24 hours
Secondary Outcome Complications occurrence (hypotension, pneumothorax, kidney injury, bowel injury, local anesthetic systemic toxicity and failure of procedures). first day after surgery - 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals El-Gharbia Govenorate,Tanta . El-Gash st. Medical Campus The Faculty of Medicine Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Fatma Alboharga ElGesih street Tanta 31511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University El-Gharbia Governorate, Tanta. El-Gash st. Medical Campus The Faculty of Medicine Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fatma Elsayed Ismaeil Aboharga Al-Geish street Tanta 31527 Egypt
Yasser Mohammed Amr Mahalla Mahalla 31527 Egypt
Ashraf Elsayed Elzeftawy Al-Geish street Tanta 31527 Egypt
Reda Sobhy Salama Al-Geish street Tanta 31527 Egypt
Hesham Elsayed Elashry Al-Geish street Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatma Aboharga dr.fatma.aboharga@gmail.com 00201227822592 Al-Geish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant lecturer
Role Name Email Phone Street address
Public Enquiries Fatma Aboharga dr.fatma.aboharga@gmail.com 00201227822592 Al-Geish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Fatma Aboharga dr.fatma.aboharga@gmail.com 00201227822592 Al-Geish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD sharing of the protocol and results can be done for justified purposes Study Protocol within 12 months of the study completion date Controlled sharing IPD sharing of the protocol and results can be done for justified purposes Team of the author will decide if the reason is justified or not
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