Retrolaminar Block Improves Postoperative Gastrointestinal System Functions:

NCT06787898 | Completed

• 1 other identifier: FSCH-SB-2024/12-14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Retrolaminar Block; Percutaneous Nephrolithotomy (PCNL)

Keywords

Percutaneous nephrolithotomy; Retrolaminar block

Outcome Measures

Primary Outcomes (1)

• 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.

  The primary outcome measures were abdominal calculation of Perlas Score (No fluid in the antrum was scored as 0, minimal fluid in the right supine position was scored as 1, and tense antrum in both supine and right supine position was scored as 2) with USG examination after extubation, hour 1, hour 3, hour 6, and hour 12

  Hour 1, Hour 3, Hour 6, and Hour 12 after surgery

Secondary Outcomes (3)

• postoperative gastrointestinal tract function

  Hour 1, Hour 3, Hour 6, Hour 12.

• Postoperative analgesia

  after extubation, Hour 1, Hour 3 , Hour 6 , and Hour 12.

• gastrointestinal tract dysfunction

  Hour 1, Hour 3,Hour 6, Hour 12.

Study Arms (2)

Group R ( The group of patients who underwent retrolaminar block for analgesia)

OTHER

Retrolaminar block is a simple and easy to perform paravertebral block. Place of application Intraoperative and postoperative analgesia is achieved by applying local anaesthetic between the lamina of the arcus vertebrae and paraspinous muscles under ultrasound guidance.

Other: Group R: retrolaminar block performed group

Group C

OTHER

Group C control group without local anaesthetic and block

Other: Group C - Placebo

Interventions

Group R: retrolaminar block performed group OTHER

Patients were placed on their side and then T9, T10 vertebrae were marked. After the skin was cleaned and the area was covered with sterile drape. A linear ultrasound probe (6-13 Hz, Hitachi Europe Ltd, Tokyo, Japan) was placed in the middle of the vertebral bodies to image the T9, T10 vertebraes. An experienced anaesthesiologist in RLB performed the procedures with a USG-guided 1-15 Hz convex probe (8-4, Hitachi Europe Ltd, Tokyo, Japan) by in-plane approach. A puncture needle (21Gx100mm, USG-Type CCR, Vygon Co. Ltd. Ecouen, France) was inserted 1 cm from the probe at a 45-degree angle to the skin, targeting the lamina of the desired vertebra. The needle was gently withdrawn to ensure that no blood or cerebrospinal fluid was present. 10 mL of 0.25% bupivacaine (Bupivon®) was injected posterior to each lamina (T9, T10), totalling 20 mL

Group R ( The group of patients who underwent retrolaminar block for analgesia)

Group C - Placebo OTHER

Patients were placed on their side and then T9, T10 vertebrae were marked. After the skin was cleaned and the area was covered with sterile drape. A linear ultrasound probe (6-13 Hz, Hitachi Europe Ltd, Tokyo, Japan) was placed in the middle of the vertebral bodies to image the T9, T10 vertebraes. An experienced anaesthesiologist in RLB performed the procedures with a USG-guided 1-15 Hz convex probe (8-4, Hitachi Europe Ltd, Tokyo, Japan) by in-plane approach. A puncture needle (21Gx100mm, USG-Type CCR, Vygon Co. Ltd. Ecouen, France) was inserted 1 cm from the probe at a 45-degree angle to the skin, targeting the lamina of the desired vertebra. The needle was gently withdrawn to ensure that no blood or cerebrospinal fluid was present. 10 mL of 0.25% bupivacaine (Bupivon®)was injected posterior to each lamina (T9, T10), totalling 20 mL.

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elazıg Fethi Sekin Sehir Hastanesi: lead

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, Seçiniz, 05055, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 31032339 RESULT

• 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.

  PMID: 33574697 RESULT

Related Links

• pubmed

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 22, 2025
• Study Start: January 22, 2025
• Primary Completion: February 12, 2025
• Study Completion: February 15, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

TU (1)