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Comparison of Ultrasound-guided Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block

Primary Purpose

Colo-rectal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nerve blocks
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colo-rectal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients subjected to abdominal cancer surgery. The enrolled age will be from 18 years to 70 years. ASA I-II and NYHA I-II. Exclusion Criteria: ASA physical status >II, and NYHA >II. Patient refusal. body mass index >40 kg/m2. preoperative opioid consumption. a local infection at the incision site. a history of hematological disorders or coagulation abnormality. previous abdominal surgeries, severe hepatic or renal impairment Anomalies of vertebral column. Pregnant women. Hypersensitivity to any of used drugs. chronic pain.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Group I : Bilateral erector spinae plane block at L1

    Group II : Transmuscular quadratus lumborum block at L1

    Arm Description

    Ultrasound (US) will be used to identify the level of L1 after skin sterilization with the patient on the lateral position. A high frequency linear-array US transducer covered in a sterile sleeve will be placed in a longitudinal parasagittal orientation 3 cm lateral to the midline to identify the trapezius above, the rhomboid major in the middle, and the erector-spinae muscle on the bottom, and the transverse Processes with shimmering pleura in between. 2-3 ml of 2% lidocaine "depocaine HCL" will be infiltrated.16-G, 8-cm Tuohy needle will be then introduced medially in the plane of the US beam and directed towards the transverse process. Once the needle is underneath the anterior fascia of the erector spinae muscle. 20 ml of bupivacaine 0.25% "sunnypivacaine" will be injected in this potential space over five minutes. The injectate will be observed spreading underneath the ES muscle lifting the muscle of the transverse process. This will be repeated on the opposite side.

    Patient will be positioned in left lateral to obtain appropriate view of QL. Aseptic precautions will be taken by wearing sterile gown and sterile drapes. By using Ultrasound MacroMaxx™ with linear probe (HFL38_10-5 MHz) covered with sterile plastic sheath SiteRite placed in the anterior axillary line to visualize the typical triple abdominal layers. Then, the probe will be placed in the midaxillary line and at this juncture the layers of abdominal layers will start to taper. When the probe will be placed in the posterior axillary line as per the posterior approach, sonoanatomy will show first the transversus abdominis disappearing then the internal oblique and external oblique forming aponeurosis and appearance of QL noticed. At the junction of the tapered ends of abdominal muscles and QL, a 21 g 100 mm SonoPlexStimu cannula needle will be inserted in plane. Under ultrasound guidance, in that space 20 mL of 0.25% bupivacaine "sunnypivacaine"will be injected separating the fascia.

    Outcomes

    Primary Outcome Measures

    postoperative analgesia
    to assess pain intensity at rest and during pain-provoking movements (deep breathing, coughing, mobilization) measured by VAS pain score (a visual analog scale scored from 0 to 10 where 0 = no pain and 10 = the worst pain imaginable) during the first 48 hours postoperatively.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 2022
    Last Updated
    June 26, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05709899
    Brief Title
    Comparison of Ultrasound-guided Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block
    Official Title
    Comparison of Ultrasound-guided Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block in Abdominal Cancer Surgeries.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 30, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The objective of this study is to compare the postoperative analgesic effect of bupivacaine injection via ultrasound-guided erector spinae block versus transmuscular quadratus lumborum block in patients undergoing abdominal cancer surgery
    Detailed Description
    Surgical trauma activates numerous receptors leading to severe postoperative pain. Therefore, effective pain management is a priority of care and a patient right . Postoperative pain may cause tachycardia, hypertension, increased cardiac work, nausea, vomiting, ileus. Also if it is inadequately managed may lead to detrimental Cardiovascular effects, pulmonary dysfunction, immune system, neuro-endocrine and metabolic effects, gastrointestinal, urinary dysfunction, coagulation system , cognitive dysfunction and also have psychological, economic and social adverse effects Good postoperative analgesia can prevent morbidity associated with abdominal surgeries by allowing pain-free, early ambulation and decreasing the risks of long hospital stay, thromboembolism, and other poor outcomes. Adequate pain treatment is an important component of modern perioperative care and essential for a fast recovery. Choosing the optimal analgesic modality remains a topic of debate especially in major abdominal surgeries. Various techniques have been tried to replicate the analgesic efficacy of TEA. They include transversus abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI) and transmuscular quadratus lumborum (TQL) analgesia. However each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for all open abdominal surgeries. The ultrasound (US)-guided erector spinae plane block (ESPB) was initially described by Forero et al.It as a relatively new technique, originally described to manage thoracic pain when performed at the T5 vertebra level, but it has also been successfully used for abdominal analgesia when performed at T7 level. ESPB gained wide attention as it is a faster procedure that carries a lower risk of hypotension, can be used in patients with coagulopathy, easy to perform, and requires less training. ESPB provides extensive, potent unilateral analgesia, performed by local anesthetic injection in the plane between the erector spinae muscle and the TP. The local anesthetic diffuses into the paravertebral space through spaces between adjacent vertebrae and blocks both the dorsal and ventral rami of the thoracic spinal nerves. Bilateral ESPB performed at low thoracic levels provides satisfactory analgesia for abdominal surgeries in case reports and series describing abdominal exploration, cesarean section, ventral hernia repair, and abdominoplasty. As LA widely spreads cranially and caudally when ESPB is performed, we think that ESPB can effectively be used as an analgesic method for abdominal surgeries. The ultrasound-guided (USG) quadratus lumborum block QLB was first described by Rafael Blanco in a presentation at ESRA 2007 at the XXVI Annual ESRA Congress in Valencia, Spain. Blanco described a potential space posterior to the abdominal wall muscles and lateral to the quadratus lumborum muscle (QL) where Local anesthetics (LA) can be injected. This technique provides analgesia after abdominal surgeries due to spread of LA from its lumbar deposition cranially into the thoracic paravertebral space (TPVS) where lateral and anterior cutaneous branches from Th7 to L1 nerves can be blocked. This was proved later by Carney et al. who found traces of contrast agent in the TPVS following the block. Quadratus lumborum block (QLB) under ultrasound has been one of the interfascial plane blocks being popularized in regional anesthesia over the last few years given the vast number of indications in a variety of abdomino-pelvic surgeries in pediatrics and adults. In clinical studies, it also has been shown to have opioid sparing effects and prolonged post-operative analgesia than more conventional procedures like TAP blocks. Several approaches have been described for QLB. Lateral QLB (or QLB-1) where local anesthetic is injected at the anterolateral border of the QL muscle. Posterior QLB (or QLB-2) where LA is injected at the junction of QL muscle with the transversalis fascia., Another novel approach is the transmuscular QLB (or QLB-3), where the needle is advanced through the QL muscle, penetrating the ventral proper fascia of the QL muscle and LA is finally injected between the QL muscle and Psoas Major (PM) muscle. It is thought that this approach (QLB-3) does not result in redundant antero-lateral spread of the LA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colo-rectal Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I : Bilateral erector spinae plane block at L1
    Arm Type
    Other
    Arm Description
    Ultrasound (US) will be used to identify the level of L1 after skin sterilization with the patient on the lateral position. A high frequency linear-array US transducer covered in a sterile sleeve will be placed in a longitudinal parasagittal orientation 3 cm lateral to the midline to identify the trapezius above, the rhomboid major in the middle, and the erector-spinae muscle on the bottom, and the transverse Processes with shimmering pleura in between. 2-3 ml of 2% lidocaine "depocaine HCL" will be infiltrated.16-G, 8-cm Tuohy needle will be then introduced medially in the plane of the US beam and directed towards the transverse process. Once the needle is underneath the anterior fascia of the erector spinae muscle. 20 ml of bupivacaine 0.25% "sunnypivacaine" will be injected in this potential space over five minutes. The injectate will be observed spreading underneath the ES muscle lifting the muscle of the transverse process. This will be repeated on the opposite side.
    Arm Title
    Group II : Transmuscular quadratus lumborum block at L1
    Arm Type
    Other
    Arm Description
    Patient will be positioned in left lateral to obtain appropriate view of QL. Aseptic precautions will be taken by wearing sterile gown and sterile drapes. By using Ultrasound MacroMaxx™ with linear probe (HFL38_10-5 MHz) covered with sterile plastic sheath SiteRite placed in the anterior axillary line to visualize the typical triple abdominal layers. Then, the probe will be placed in the midaxillary line and at this juncture the layers of abdominal layers will start to taper. When the probe will be placed in the posterior axillary line as per the posterior approach, sonoanatomy will show first the transversus abdominis disappearing then the internal oblique and external oblique forming aponeurosis and appearance of QL noticed. At the junction of the tapered ends of abdominal muscles and QL, a 21 g 100 mm SonoPlexStimu cannula needle will be inserted in plane. Under ultrasound guidance, in that space 20 mL of 0.25% bupivacaine "sunnypivacaine"will be injected separating the fascia.
    Intervention Type
    Other
    Intervention Name(s)
    nerve blocks
    Intervention Description
    Comparison of ultrasound-guided erector spinae plane block and transmuscular quadratus lumborum block for postoperative analgesia in abdominal cancer surgeries.
    Primary Outcome Measure Information:
    Title
    postoperative analgesia
    Description
    to assess pain intensity at rest and during pain-provoking movements (deep breathing, coughing, mobilization) measured by VAS pain score (a visual analog scale scored from 0 to 10 where 0 = no pain and 10 = the worst pain imaginable) during the first 48 hours postoperatively.
    Time Frame
    First 48 hours after surgery.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients subjected to abdominal cancer surgery. The enrolled age will be from 18 years to 70 years. ASA I-II and NYHA I-II. Exclusion Criteria: ASA physical status >II, and NYHA >II. Patient refusal. body mass index >40 kg/m2. preoperative opioid consumption. a local infection at the incision site. a history of hematological disorders or coagulation abnormality. previous abdominal surgeries, severe hepatic or renal impairment Anomalies of vertebral column. Pregnant women. Hypersensitivity to any of used drugs. chronic pain.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rana Ahmed Hamed Mohamed, resident doctor
    Phone
    00201050905843
    Email
    rana.14231949@med.aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ashraf Amin Mohamed, professor
    Phone
    00201012142511
    Email
    ashrafkena@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23945838
    Citation
    Azari L, Santoso JT, Osborne SE. Optimal pain management in total abdominal hysterectomy. Obstet Gynecol Surv. 2013 Mar;68(3):215-27. doi: 10.1097/OGX.0b013e31827f5119.
    Results Reference
    background
    PubMed Identifier
    17116561
    Citation
    Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg. 2006 Dec;203(6):914-32. doi: 10.1016/j.jamcollsurg.2006.08.007. Epub 2006 Oct 25. No abstract available.
    Results Reference
    background
    PubMed Identifier
    28727597
    Citation
    Restrepo-Garces CE, Chin KJ, Suarez P, Diaz A. Bilateral Continuous Erector Spinae Plane Block Contributes to Effective Postoperative Analgesia After Major Open Abdominal Surgery: A Case Report. A A Case Rep. 2017 Dec 1;9(11):319-321. doi: 10.1213/XAA.0000000000000605.
    Results Reference
    background
    PubMed Identifier
    27501016
    Citation
    Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
    Results Reference
    background
    PubMed Identifier
    27997492
    Citation
    Ueshima H, Otake H. Similarities Between the Retrolaminar and Erector Spinae Plane Blocks. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):123-124. doi: 10.1097/AAP.0000000000000526. No abstract available.
    Results Reference
    background
    PubMed Identifier
    28188621
    Citation
    Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
    Results Reference
    background
    PubMed Identifier
    22476239
    Citation
    Borglum J, Jensen K, Christensen AF, Hoegberg LC, Johansen SS, Lonnqvist PA, Jansen T. Distribution patterns, dermatomal anesthesia, and ropivacaine serum concentrations after bilateral dual transversus abdominis plane block. Reg Anesth Pain Med. 2012 May-Jun;37(3):294-301. doi: 10.1097/AAP.0b013e31824c20a9.
    Results Reference
    background
    PubMed Identifier
    21851346
    Citation
    Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.
    Results Reference
    background
    PubMed Identifier
    29352577
    Citation
    Yamak Altinpulluk E, Garcia Simon D, Fajardo-Perez M. Erector spinae plane block for analgesia after lower segment caesarean section: Case report. Rev Esp Anestesiol Reanim (Engl Ed). 2018 May;65(5):284-286. doi: 10.1016/j.redar.2017.11.006. Epub 2018 Jan 17. English, Spanish.
    Results Reference
    result

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    Comparison of Ultrasound-guided Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block

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