- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07604259
Comparison of QLB and TFP Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia
Comparison of the Effects of Ultrasound-Guided Lateral Quadratus Lumborum Block and Transversalis Fascia Plane Block on Postoperative Analgesia in Patients Undergoing Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Laparoscopic inguinal hernia repair is a standard, minimally invasive procedure. However, moderate pain is common in the first 24 hours postoperatively, originating from somatic pain at trocar sites and visceral pain from peritoneal irritation and mesh placement. Multimodal analgesia, including fascial plane blocks, is recommended to reduce opioid consumption and improve pain control.
In this prospective, randomized, controlled, single-center trial, 90 patients (ASA I-III, aged 18-65) scheduled for elective laparoscopic inguinal hernia repair under general anesthesia will be allocated into three parallel arms (n=30 each) via computer-based randomization.
Group QLB: Will receive bilateral ultrasound-guided lateral Quadratus Lumborum Block (total 40 mL 0.25% bupivacaine) prior to extubation, along with 10 mL 0.25% bupivacaine infiltration at port sites.
Group TFP: Will receive bilateral ultrasound-guided Transversalis Fascia Plane Block (total 40 mL 0.25% bupivacaine) prior to extubation, along with 10 mL 0.25% bupivacaine infiltration at port sites.
Group Control: Will receive only port site infiltration (total 20 mL 0.25% bupivacaine).
All procedures will be performed aseptically by the same surgical and anesthesia team. Postoperatively, all patients will receive 1 g intravenous paracetamol every 8 hours. Postoperative pain will be assessed using the Numeric Rating Scale (NRS) by an anesthesiologist blinded to the group allocation. Intravenous tramadol (100 mg) will be administered as rescue analgesia if the NRS score is ≥ 4. Total 24-hour tramadol consumption, along with block-related complications and opioid-related side effects (nausea, vomiting, sedation), will be recorded.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Istanbul, Tyrkiet (Türkiye)
- İstanbul Medipol University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Scheduled for elective laparoscopic inguinal hernia repair.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Age between 18 and 65 years.
- Provided written informed consent.
Exclusion Criteria:
- History of allergy to local anesthetics.
- Presence of coagulopathy.
- Signs of infection at the intended block application site.
- Body Mass Index (BMI) ≥ 35 kg/m².
- History of chronic opioid use.
- Presence of neurological disease.
- Refusal to participate in the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Group QLB
Patients will receive bilateral lateral Quadratus Lumborum Block (QLB) and port site infiltration at the end of the surgery.
|
Bilateral ultrasound-guided lateral QLB with 20 mL of 0.25% bupivacaine per side (total 40 mL).
Plus, 10 mL of 0.25% bupivacaine infiltration at trocar insertion sites.
|
|
Eksperimentel: Group TFP
Patients will receive bilateral Transversalis Fascia Plane (TFP) block and port site infiltration at the end of the surgery.
|
Bilateral ultrasound-guided TFP block with 20 mL of 0.25% bupivacaine per side (total 40 mL).
Plus, 10 mL of 0.25% bupivacaine infiltration at trocar insertion sites.
|
|
Aktiv komparator: Group Control
Patients will receive only port site infiltration at the end of the surgery.
|
Local infiltration of 20 mL of 0.25% bupivacaine at the trocar insertion sites.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Numeric Rating Scale (NRS) Pain Score
Tidsramme: At 0, 3, 6, 12, 18, and 24 hours postoperatively.
|
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS).
The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain".
Higher scores represent worse pain outcomes.
|
At 0, 3, 6, 12, 18, and 24 hours postoperatively.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Tramadol Consumption
Tidsramme: During the first 24 hours postoperatively.
|
The cumulative dose of intravenous tramadol (in milligrams) administered as rescue analgesia.
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During the first 24 hours postoperatively.
|
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Need for Rescue Analgesia
Tidsramme: During the first 24 hours postoperatively
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The number of patients requiring rescue analgesia (tramadol 100 mg IV) when the NRS score is ≥ 4.
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During the first 24 hours postoperatively
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Incidence of Opioid-Related Side Effects
Tidsramme: During the first 24 hours postoperatively.
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The number of patients experiencing postoperative nausea, vomiting, or sedation.
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During the first 24 hours postoperatively.
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Incidence of Block-Related Complications
Tidsramme: During the first 24 hours postoperatively.
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The number of patients experiencing complications related to the regional block application, such as hematoma, infection, or local anesthetic systemic toxicity (LAST).
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During the first 24 hours postoperatively.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- İnguinal QLB vs TFP
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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