Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
NCT Number: NCT07720817
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.
Trial opening soon.
Get Notified21 year–65 year
All sexes
Interventional
Not applicable
Al Mansurah, Dakahlia Governorate, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided bilateral retrolaminar block performed before surgery using the study local anesthetic.
Ultrasound-guided bilateral transversus abdominis plane (TAP) block performed before surgery using the study local anesthetic.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative nausea
Time frame: From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative vomiting
Time frame: From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative shivering
Time frame: From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative hypotension
Time frame: From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative bradycardia
Time frame: From the end of surgery to 24 hours after surgery
Number of participants who experienced postoperative headache
Time frame: 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).
Time frame: From induction of anesthesia until the end of surgery
Number of participants who required ephedrine administration for the treatment of intraoperative hypotension.
Contact information is provided by the study sponsor or research team.
Mansoura University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07711496
Pediatric Postoperative Pain, Pediatric Regional Anesthesia
Bakırköy, Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06725680
Enhanced Recovery, Erector Spinae Plane Block
Tanta, El-Gharbia, Egypt
View Trial DetailsNCT06088836
Erector Spinae Plane Block, Multiple Rib Fractures
Tanta, El-Gharbia, Egypt
View Trial DetailsNCT06787898
Percutaneous Nephrolithotomy (PCNL), Retrolaminar Block
Elâzığ, Seçiniz, Turkey (Türkiye)
View Trial Details