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Ultrasound Guided Retrolaminar Block Versus Transverse Abdominis Plane Block in Laparoscopic Upper Abdominal Surgeries

11. September 2026 aktualisiert von: Mansoura University

Safety and Efficacy of Ultrasound Guided Retrolaminar Block Versus Transverse Abdominis Plane Block on Quality of Recovery in Laparoscopic Upper Abdominal Surgeries: A Randomized Comparative Clinical Trial

This study aims to compare and evaluate the safety and efficacy of ultrasound guided retrolaminar block versus transverse abdominis plane block in laparoscopic upper abdominal surgeries. Both RLB and TAP blockade are hypothesized to reduce analgesic consumption, manage pain effectively and minimize side effects but their comparative effectiveness has not yet to be thoroughly explored.

Studienübersicht

Detaillierte Beschreibung

Laparoscopic surgery is now a widely accepted practice, offering several advantages, including better cosmetic outcomes, increased patient satisfaction, and shorter hospital stays . The complexity and range of procedures performed laparoscopically have grown significantly, now including complex operations like cholecystectomy, nephrectomy, hernia repair, and an increasing number of emergency surgeries .

Despite these benefits, postoperative pain following laparoscopic procedures, such as cholecystectomy, can be substantial and hinder recovery . This pain may negatively affect respiratory function, delay ambulation, and ultimately prolong their hospital stay. Historically, pain management has often relied on high doses of narcotics, which may lead to complications like dizziness, respiratory depression, and postoperative nausea and vomiting (PONV) . These drawbacks have spurred the search for alternative and improved pain relief strategies .

Ultrasound-guided nerve blocks have become an essential component of multimodal postoperative analgesia due to their effectiveness, precision, and safety profile . One of such techniques is the Transversus Abdominis Plane (TAP) block, which is used as part of a comprehensive strategy to optimize postoperative pain control. Local anesthetic is injected into the neurovascular plane of the abdominal wall . The TAP block works by providing sensory blockade to the spinal nerves that run between the internal oblique and transverse abdominis muscles. The anesthetic infiltration affects the thoracic intercostal nerves, the ilioinguinal and iliohypogastric nerves, and the lateral cutaneous branches of the lumbar nerves.

Another important technique is the Retrolaminar Block (RLB), introduced in 2006 as a simpler alternative to the thoracic paravertebral block (TPVB) . The RLB is less invasive because it targets the bony vertebral lamina, unlike the TPVB, which requires puncturing the superior costotransverse ligament . The procedure involves injecting a local anesthetic (LA) into the fascial plane located between the posterior thoracic lamina and the overlying transversus spinae muscles allowing spread of the local anesthetic to the thoracic paravertebral and epidural spaces, thus the blockade of the dorsal branch of the spinal nerves that cross the retrolaminar plane .Studies, including cadaveric models, have confirmed that the anesthetic injected during an RLB spreads through the intertransverse ligaments into the paravertebral and epidural spaces, effectively numbing 2-4 spinal segments . For instance, a 2022 clinical trial showed that ultrasound-guided RLBs significantly reduced opioid consumption in patients recovering from laparoscopic cholecystectomy compared to conventional pain management , highlighting its potential as a safe and effective option.

Studientyp

Interventionell

Einschreibung (Geschätzt)

164

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: mohamed elnagar Mohamed A. Elnagar MB BCh, MB BCh
  • Telefonnummer: +20 1009344804
  • E-Mail: melnaggar789@gmail.com

Studienorte

    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Ägypten
        • Rekrutierung
        • Mansoura University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Age between 21 and 65 years.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Body mass index (BMI) less than 30 kg/m².
  • Scheduled for elective laparoscopic upper abdominal surgery under general anesthesia.

Exclusion Criteria:

  • Refusal to participate in the study.
  • Known allergy or hypersensitivity to any of the study drugs.
  • Infection at the planned block insertion site.
  • Severe uncontrolled cardiac, renal, hepatic, neurological, or respiratory disease.
  • Pre-existing chronic pain.
  • Immunodeficiency.
  • Coagulation abnormalities, anticoagulant therapy, or platelet count less than 80,000/µL.
  • Emergency surgery.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Retrolaminar Block Group
Patients will receive an ultrasound-guided retrolaminar block using 20 ml of 0.25% of bupivacaine administered at the T7 level at both sides
Ultrasound-guided bilateral retrolaminar block performed before surgery using the study local anesthetic.
Aktiver Komparator: Transverses Abdominis Plane (TAP) Block Group
Patients will receive an ultrasound-guided TAP block using 20 ml of 0.25% bupivacaine at both sids
Ultrasound-guided bilateral transversus abdominis plane (TAP) block performed before surgery using the study local anesthetic.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The postoperative Quality of Recovery-15 score
Zeitfenster: 24 hour postoperative
The Quality of Recovery-15 (QoR-15) questionnaire consists of 15 items. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery.
24 hour postoperative

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Numeric Rating Scale (NRS) at rest and during coughing
Zeitfenster: Immediately after arrival in the post-anesthesia care unit (0 hours), and at 2, 4, 6, 12, and 24 hours after surgery.
Postoperative pain intensity at rest and during coughing will be assessed using the Numeric Rating Scale (NRS). The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain . Higher scores indicate greater pain intensity (worse outcome).
Immediately after arrival in the post-anesthesia care unit (0 hours), and at 2, 4, 6, 12, and 24 hours after surgery.
Total dose of rescue analgesics administered (mg) within the first 24 hours after surgery
Zeitfenster: From the end of surgery to 24 hours after surgery.
The cumulative dose of rescue postoperative analgesics administered to each participant during the first 24 hours after surgery will be recorded. Higher values indicate greater postoperative analgesic requirements.
From the end of surgery to 24 hours after surgery.
Time to first postoperative opioid analgesic request (hours)
Zeitfenster: From the end of surgery until the first request for opioid analgesia, up to 24 hours postoperatively
Time from the end of surgery until the first postoperative request for opioid analgesia
From the end of surgery until the first request for opioid analgesia, up to 24 hours postoperatively
Duration of hospital stay
Zeitfenster: From the date of surgery until hospital discharge, assessed for up to 30 days after surgery
Duration of hospital stay, measured as the number of days from the date of surgery until hospital discharge.
From the date of surgery until hospital discharge, assessed for up to 30 days after surgery
Mean intraoperative mean arterial pressure (mmHg)
Zeitfenster: At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
Mean arterial pressure (MAP), measured in millimeters of mercury (mmHg), will be recorded during surgery
At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
Mean intraoperative heart rate (beats/min)
Zeitfenster: At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
Heart rate (HR), measured in beats per minute (beats/min), will be recorded during surgery
At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
Mean intraoperative peripheral oxygen saturation (%)
Zeitfenster: At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
Peripheral oxygen saturation (SpO₂), measured as percentage (%), will be recorded during surgery
At baseline (before block), immediately after block (0 minutes), at 5, 10, 20, 30, 60, 90, and 120 minutes after block , or until the end of surgery, whichever occurs first.
Number of participants with postoperative nausea
Zeitfenster: From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative nausea
From the end of surgery to 24 hours after surgery
Number of participants with postoperative vomiting
Zeitfenster: From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative vomiting
From the end of surgery to 24 hours after surgery
Number of participants with postoperative shivering
Zeitfenster: From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative shivering
From the end of surgery to 24 hours after surgery
Number of participants with postoperative hypotension
Zeitfenster: From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative hypotension
From the end of surgery to 24 hours after surgery
Number of participants with postoperative bradycardia
Zeitfenster: From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative bradycardia
From the end of surgery to 24 hours after surgery
Number of participants with postoperative headache
Zeitfenster: From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative headache
From the end of surgery to 24 hours after surgery
Total intraoperative ephedrine dose administered (mg)
Zeitfenster: From induction of anesthesia until the end of surgery
The cumulative dose of ephedrine administered intraoperatively for the treatment of hypotension, measured in milligrams (mg).
From induction of anesthesia until the end of surgery
Number of participants requiring intraoperative ephedrine administration
Zeitfenster: From induction of anesthesia until the end of surgery
Number of participants who required ephedrine administration for the treatment of intraoperative hypotension.
From induction of anesthesia until the end of surgery

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienstuhl: hatem saber mohamed ali, Professor, Faculty of Medicine, Mansoura University
  • Studienstuhl: Naglaa A Elnegeery, Associate Professor, Faculty of Medicine, Mansoura University
  • Studienleiter: Ola Shawky Naguib El Nagar, Lecturer, Faculty of Medicine, Mansoura University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. Februar 2027

Studienanmeldedaten

Zuerst eingereicht

1. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Juli 2026

Zuerst gepostet (Tatsächlich)

22. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. September 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • Retrolamianr and TAP blocks

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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