Retrolaminar BlockNCT06787898
Retrolaminar Block Improves Postoperative Gastrointestinal System Functions:
A study testing Group R: retrolaminar block performed group in people with Retrolaminar Block and Percutaneous Nephrolithotomy (PCNL), run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Retrolaminar Block, Percutaneous Nephrolithotomy (PCNL)
- What is being tested?
- Group R: retrolaminar block performed group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2025to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA (American Society of Anesthesiologists) I-II-III,
- 18-65 years
- unilateral PNL performed under elective conditions
Who cannot join
- 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,
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elazığ Fethi Sekin City Hospital
Elâzığ, Seçiniz, 05055
About this study
Official title: 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.
Read the 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.
- Being tested
- Group R: retrolaminar block performed group, Group C - Placebo
- Keywords
- Percutaneous nephrolithotomy, Retrolaminar block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group R: retrolaminar block performed groupOther
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 - PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Group R: retrolaminar block performed group |
| Group C | Other | Group C control group without local anaesthetic and block Receives: Other: Group C - Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Hour 1, Hour 3, Hour 6, and Hour 12 after surgery
Secondary outcomes (3)
postoperative gastrointestinal tract function
time of first oral feeding, flatus, defecation, mobilisation (min); rescue analgesia time (min) postoperative.
Measured: Hour 1, Hour 3, Hour 6, Hour 12.
Postoperative analgesia
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)
Measured: after extubation, Hour 1, Hour 3 , Hour 6 , and Hour 12.
gastrointestinal tract dysfunction
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).
Measured: Hour 1, Hour 3,Hour 6, Hour 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start22 Jan 2025
- Primary completion12 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retrolaminar BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Bayındır, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787898
- Sponsor's protocol ID
- FSCH-SB-2024/12-14
- Status last verified
- Feb 2025
- First submitted
- 22 Dec 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31032339Liu 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.
PubMed 33574697
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USG-Guided Retrolaminar Block Improves Postoperative Gastrointestinal System Functions in Percutaneous Nephrolithotomy Patients: A Prospective, Randomised, Clinical Study
- ClinicalTrials.gov ID
- NCT06787898
- Acronym / sponsor ID
- FSCH-SB-2024/12-14
- Keywords
- Percutaneous nephrolithotomy, Retrolaminar block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group R ( The group of patients who underwent retrolaminar block for analgesia) | Other | Other: Group R: retrolaminar block performed groupRetrolaminar 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 C | Other | Other: Group C - PlaceboGroup C control group without local anaesthetic and block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA (American Society of Anesthesiologists) I-II-III,
- 18-65 years
- unilateral PNL performed under elective conditions
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group R: retrolaminar block performed groupPatients 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 R ( The group of patients who underwent retrolaminar block for analgesia) |
| Group C - PlaceboPatients 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 |
Primary outcome
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
3 secondary outcomes
postoperative gastrointestinal tract function
Time frame: Hour 1, Hour 3, Hour 6, Hour 12.
Postoperative analgesia
Time frame: after extubation, Hour 1, Hour 3 , Hour 6 , and Hour 12.
gastrointestinal tract dysfunction
Time frame: Hour 1, Hour 3,Hour 6, Hour 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Results publication: PubMed 31032339Onishi 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.
- Results publication: PubMed 33574697Liu 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.
- pubmedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group R: retrolaminar block performed group in people with Retrolaminar Block and Percutaneous Nephrolithotomy (PCNL), run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Hour 1, Hour 3, Hour 6, and Hour 12 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787898, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.