Retrolaminar Block Improves Postoperative Gastrointestinal System Functions:

February 18, 2025 updated by: Serpil Bayındır, Elazıg Fethi Sekin Sehir Hastanesi

USG-Guided Retrolaminar Block Improves Postoperative Gastrointestinal System Functions in Percutaneous Nephrolithotomy Patients: A Prospective, Randomised, Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Seçiniz
      • Elazığ, Seçiniz, Turkey, 05055
        • Elazığ Fethi Sekin City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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
Other: Group C
Group C control group without local anaesthetic and block
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Hour 1, Hour 3, Hour 6, and Hour 12 after 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative gastrointestinal tract function
Time Frame: Hour 1, Hour 3, Hour 6, Hour 12.
time of first oral feeding, flatus, defecation, mobilisation (min); rescue analgesia time (min) postoperative.
Hour 1, Hour 3, Hour 6, Hour 12.
Postoperative analgesia
Time Frame: after extubation, Hour 1, Hour 3 , Hour 6 , and Hour 12.
VAS Scores (Visual Analog Scale) (In a VAS score of 1-10, each number represents a rough equivalent of the intensity of pain felt. 0: No pain, 10: Intolerable most severe pain)
after extubation, Hour 1, Hour 3 , Hour 6 , and Hour 12.
gastrointestinal tract dysfunction
Time Frame: Hour 1, Hour 3,Hour 6, Hour 12.
İ-FEED Score values (The I-FEED (intake, nausea sensation, vomiting, physical examination and duration of symptoms) Score was calculated and patients were then categorized into one of three groups: Normal gastrointestinal function score 0-2, postoperative gastrointestinal intolerance (nausea, vomiting or abdominal distension) score 3-5, postoperative ileus score 6-10).
Hour 1, Hour 3,Hour 6, Hour 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elazıg Fethi Sekin Sehir Hastanesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2025

Primary Completion (Actual)

February 12, 2025

Study Completion (Actual)

February 15, 2025

Study Registration Dates

First Submitted

December 22, 2024

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FSCH-SB-2024/12-14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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