Epidural Versus Quadratus Lamborum Block in Adult Open Nephrectomies

NCT ID: NCT05174364

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Our primary objective is to compare the effectiveness of bilateral QLB and epidural analgesia for postoperative management using VAS measured in PACU until 24 hours after surgery in patients undergoing elective open nephrectomies under GA. The secondary outcomes include: The 1st time to rescue analgesia and total amount of opioid consumption throughout the first postoperative day. hemodynamic variables. Any complications as postoperative nausea and vomiting (PONV) and sedation. The sensory block coverage \& the Bromage score at 2, 6, 12, and 24 hours after anesthesia recovery and duration of urinary catheter usage. Duration of PACU stay and postoperative duration of hospitalization and Patients' satisfaction.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Open surgery remains basic surgery for patients requiring radical or partial nephrectomy and is associated with a high incidence of intense immediate postoperative pain and chronic pain the months following surgery. The physiopathology of acute pain is explained as it is mediated by inflammatory cell infiltration, activation of the pain pathways in the spinal cord, and reflexive muscle spasm. All these three mechanisms of acute pain are typically ameliorated during the postoperative recovery. Regional anesthesia techniques are commonly enhanced for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction.

QLB has been introduced as a component of multimodal analgesia for thoracic and abdominal surgeries as:

cesarean section, hip arthroplasty, inguinal hernia repair and nephrectomies. It provides a great spread of local anesthesia which allows anesthesia from T6 - L2 and provides loss of somatic and visceral pain. The QLB was initially described by R.Blanco where the local anesthetic (LA) was injected at the anterolateral aspect of the QL muscle (type 1 QLB). Later, J.

Børglum used the posterior transmuscular approach by detecting Shamrock sign and injecting the LA at the anterior aspect of the QL (type 3 QLB). Recently, R. Blanco described another approach by injecting the LA at the posterior aspect of the QL muscle (type 2 QLB), which may be easier and safer as the LA is injected in a more superficial plane, so the risk of intra-abdominal complications and lumbar plexus injuries is less. Finally, the intramuscular QLB (type 4 QLB) was done by injecting LA directly into the QL muscle. QLBs may be particularly useful in nephrectomy as it lacks the adverse effects associated with patient controlled analgesia including nausea, vomiting, sedation, and respiratory depression, as well as side effects of patient controlled epidural analgesia such as pruritus hypotension, and urinary retention. Our hypothesis is that performing ultrasound guided QLB will be more superior or equal to epidural block in providing postoperative analgesia for patients undergoing open nephrectomy under general anesthesia

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Operative Analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Epidural Block

Epidural block for the control group will be done before induction of general anesthesia. Patients will be positioned in the sitting position, an 18-gauge Tuohy needle will be inserted into epidural space of Th 11-12 intervertebral space under aseptic condition. In the medial approach, the site of the insertion of the needle is between the spaces created by the vertebral spinous processes. Upon locating the desired spot, lidocaine 1% must be injected into the skin and underlying tissues to decrease the discomfort with the advancement of the epidural needle

No interventions assigned to this group

Quadratus Lumborum Block

Bilateral QL block type 3 (anterior) for the intervention group will be performed on both sides of the patient after induction of general anesthesia. Patient will be positioned in semi-lateral decubitus and using low-frequency ultrasonography (USG) guidance attached to inferior lumbar region (Petit's triangle) that is consisted of inferior iliac crest and bordered by two muscles such as latissimus dorsi muscle in the posterior, abdominal external oblique muscle in the anterior. The USG will display the Shamrock sign, where the transverse process of vertebrae L4 role as the trunk, erector spinae muscle on the posterior side, psoas major (PM) on the anterior side, and QL muscle on the lateral side. After the visualization of QL and PM muscles, the Contiplex R needle will be directed parallel to the posterior side of the ultrasound probe until the tip of needle is confirmed in the border of QL and PM muscle

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients of American Society of Anesthesiologists (ASA) class I or II physical status.
* Age:20-60 years old.
* Patients scheduled for open nephrectomies .
* Gender: both

Exclusion Criteria

* Patient refusal.
* Significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).
* Morbid obesity (BMI \>35).
* Patient with known hypersensitivity to amide local anesthetics or morphine.
* Patient with any contraindication for intrathecal anesthesia, e.g. coagulopathy.
* Psychiatric disorders, which will make observational pain intensity assessment difficult.
* Pregnancy.
* Skin lesions or wounds at the puncture site of the proposed block .
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

SABastawy

M.M.B.CH & Resident Doctor at Anesthesia and Intensive Care Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kelani A. Abd El-Salam, Professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sarah A. Bastawy, resident

Role: CONTACT

00201121409356

Ragaa A. Herdan, Ass. prof.

Role: CONTACT

00201001741748

References

Explore related publications, articles, or registry entries linked to this study.

Gupta V, Yadav SK, Dean E, Vincent P, Walid F, Al Said A. Paediatric laparoscopic orchidopexy as a novel mentorship: Training model. Afr J Paediatr Surg. 2013 Apr-Jun;10(2):117-21. doi: 10.4103/0189-6725.115035.

Reference Type BACKGROUND
PMID: 23860059 (View on PubMed)

Bravi CA, Larcher A, Capitanio U, Mari A, Antonelli A, Artibani W, Barale M, Bertini R, Bove P, Brunocilla E, Da Pozzo L, Di Maida F, Fiori C, Gontero P, Li Marzi V, Longo N, Mirone V, Montanari E, Porpiglia F, Schiavina R, Schips L, Simeone C, Siracusano S, Terrone C, Trombetta C, Volpe A, Montorsi F, Ficarra V, Carini M, Minervini A. Perioperative Outcomes of Open, Laparoscopic, and Robotic Partial Nephrectomy: A Prospective Multicenter Observational Study (The RECORd 2 Project). Eur Urol Focus. 2021 Mar;7(2):390-396. doi: 10.1016/j.euf.2019.10.013. Epub 2019 Nov 12.

Reference Type BACKGROUND
PMID: 31727523 (View on PubMed)

Popping DM, Zahn PK, Van Aken HK, Dasch B, Boche R, Pogatzki-Zahn EM. Effectiveness and safety of postoperative pain management: a survey of 18 925 consecutive patients between 1998 and 2006 (2nd revision): a database analysis of prospectively raised data. Br J Anaesth. 2008 Dec;101(6):832-40. doi: 10.1093/bja/aen300. Epub 2008 Oct 22.

Reference Type BACKGROUND
PMID: 18945716 (View on PubMed)

Capdevila X, Moulard S, Plasse C, Peshaud JL, Molinari N, Dadure C, Bringuier S. Effectiveness of Epidural Analgesia, Continuous Surgical Site Analgesia, and Patient-Controlled Analgesic Morphine for Postoperative Pain Management and Hyperalgesia, Rehabilitation, and Health-Related Quality of Life After Open Nephrectomy: A Prospective, Randomized, Controlled Study. Anesth Analg. 2017 Jan;124(1):336-345. doi: 10.1213/ANE.0000000000001688.

Reference Type BACKGROUND
PMID: 27918333 (View on PubMed)

Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.

Reference Type BACKGROUND
PMID: 30688787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17116561 (View on PubMed)

Wilkinson KM, Krige A, Brearley SG, Lane S, Scott M, Gordon AC, Carlson GL. Thoracic Epidural analgesia versus Rectus Sheath Catheters for open midline incisions in major abdominal surgery within an enhanced recovery programme (TERSC): study protocol for a randomised controlled trial. Trials. 2014 Oct 21;15:400. doi: 10.1186/1745-6215-15-400.

Reference Type BACKGROUND
PMID: 25336055 (View on PubMed)

Dhanjal ST, Tonder S. Quadratus Lumborum Block. 2023 Aug 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537212/

Reference Type BACKGROUND
PMID: 30725897 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Open nephrectomies

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.