Clinical trial NCT06787898: Retrolaminar Block Improves Postoperative Gastrointestinal System Functions:
Official title: USG-Guided Retrolaminar Block Improves Postoperative Gastrointestinal System Functions in Percutaneous Nephrolithotomy Patients: A Prospective, Randomised, Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retrolaminar Block
Percutaneous Nephrolithotomy (PCNL)
Keywords: Percutaneous nephrolithotomy
Retrolaminar block
Lead sponsor: Elazıg Fethi Sekin Sehir Hastanesi
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Rapid recovery of postoperative bowel function is one of the important goals of accelerated recovery after surgery (ERAS protocols). Gastrointestinal dysfunctions may occur after general anaesthesia. All these lead to a series of adverse outcomes including prolonged hospital stay, high treatment costs and deterioration of patient comfort.

Percutaneous nephrolithotomy (PNL) is the treatment of choice for sizable and intricate kidney stones. Providing effective postoperative pain control is important in preventing respiratory and thromboembolic complications and ensuring patient comfort as well as shortening the hospital stay. The application of USG-guided nerve blocks for analgesia reduces intraoperative opioid use and provides early recovery of postoperative GI dysfunctions. Retrolaminar block (RLB), have been shown to reduce perioperative opioid consumption. Nerve blocks may relieve inflammation-related gastrointestinal dysfunctions by attenuating postoperative inflammatory responses.

This study aimed to determine the effects of USG-guided retrolaminar block on the postoperative gastrointestinal system in patients undergoing PNL.

Detailed description: Rapid recovery of postoperative bowel function is one of the important goals of accelerated recovery after surgery (ERAS protocols). Gastrointestinal dysfunctions such as nausea-vomiting, distension, slowing of intestinal peristalsis, ileus, fatigue, delayed gastric emptying and delayed oral active eating may occur after general anaesthesia. All these lead to a series of adverse outcomes including prolonged hospital stay, high treatment costs and deterioration of patient comfort.

Percutaneous nephrolithotomy (PNL) is the treatment of choice for sizable (\>2 cm) and intricate kidney stones. This minimally invasive surgical technique entails the creation of a percutaneous tract through which specialised instruments are inserted to fragment and extract the renal calculi. In the first 24 hours postoperatively, incisional pain is both somatic and visceral in character due to distension in the renal capsule-pelvic- pelvical system and the inserted nephrostomy tube and is carried by the T8-L1 spinal nerves. Blocking the nerves innervating these regions provides an effective analgesia. Providing effective postoperative pain control is important in preventing respiratory and thromboembolic complications and ensuring patient comfort as well as shortening the hospital stay. The application of USG-guided nerve blocks for analgesia reduces intraoperative opioid use and provides early recovery of postoperative GI dysfunctions. Various nerve blocks including retrolaminar block (RLB), erector spina area block (ESPB), and trans abdominal area block (TAPB) have been shown to reduce perioperative opioid consumption. Nerve blocks may relieve inflammation-related gastrointestinal dysfunctions by attenuating postoperative inflammatory responses.

This study aimed to determine the effects of USG-guided retrolaminar block on the postoperative gastrointestinal system in patients undergoing percutaneous nephrolithotomy.

Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anesthesiologists) I-II-III,
* 18-65 years
* unilateral PNL performed under elective conditions

Exclusion Criteria:

* body mass index \> 40 kg/m2,
* inability to understand the pain verbal rating scale and patient-controlled analgesia,
* emergency reoperations,
* ASA 4 or 5,
* drug and alcohol dependence,
* drug allergy,
* Coagulation disorders,
* anatomical abnormalities of the genitourinary system,
* gastrointestinal motility disorders,
* previous abdominal surgery,
* cognitive or psychiatric disorders, mental disorders,
* presence of severe systemic disease

Primary outcomes:
measure: The primary outcome was the detection of gastrointestinal motility disorders (peristaltic activity) in the postoperative period with intermittent USG imaging as a result of decreased opioid consumption during surgery.
timeFrame: Hour 1, Hour 3, Hour 6, and Hour 12 after surgery
Secondary outcomes:
measure: postoperative gastrointestinal tract function
timeFrame: Hour 1, Hour 3, Hour 6, Hour 12.
measure: Postoperative analgesia
timeFrame: after extubation, Hour 1, Hour 3 , Hour 6 , and Hour 12.
measure: gastrointestinal tract dysfunction
timeFrame: Hour 1, Hour 3,Hour 6, Hour 12.
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Elazığ Fethi Sekin City Hospital
state: Seçiniz
Study officials:
References:
citation: Onishi E, Toda N, Kameyama Y, Yamauchi M. Comparison of Clinical Efficacy and Anatomical Investigation between Retrolaminar Block and Erector Spinae Plane Block. Biomed Res Int. 2019 Mar 28;2019:2578396. doi: 10.1155/2019/2578396. eCollection 2019.
citation: Liu D, Xu X, Zhu Y, Liu X, Zhao F, Liang G, Zhu Z. Safety and Efficacy of Ultrasound-Guided Retrolaminar Block of Multiple Injections in Retroperitoneal Laparoscopic Nephrectomy: A Prospective Randomized Controlled Study. J Pain Res. 2021 Feb 5;14:333-342. doi: 10.2147/JPR.S282500. eCollection 2021.