Retrolaminar Block Improves Postoperative Gastrointestinal System Functions:

NCT ID: NCT06787898

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-22
• Study Completion Date: 2025-02-15

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.

Conditions

Retrolaminar Block; Percutaneous Nephrolithotomy (PCNL)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

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.

Group Type: OTHER

Group R: retrolaminar block performed group

Intervention Type: 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

Group C control group without local anaesthetic and block

Group Type: OTHER

Group C - Placebo

Intervention Type: 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.

Interventions

Group R: retrolaminar block performed group

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

Intervention Type: OTHER

Group C - Placebo

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elazıg Fethi Sekin Sehir Hastanesi

OTHER

Sponsor Role: lead

Responsible Party

Serpil Bayındır

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Elazığ Fethi Sekin City Hospital

Elâzığ, Seçiniz, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 31032339 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33574697 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/33574697/

pubmed

Other Identifiers

FSCH-SB-2024/12-14

Identifier Type: -

Identifier Source: org_study_id