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Comparison of QLB and TFP Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia

Conditionsİnguinal HerniaPost Operative Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedipol University

About this trial

This randomized controlled trial aims to compare the effects of ultrasound-guided lateral Quadratus Lumborum Block (QLB) and Transversalis Fascia Plane (TFP) block on postoperative analgesia in patients undergoing laparoscopic inguinal hernia repair. Ninety patients will be randomly assigned to one of three groups: Group QLB, Group TFP, or Group Control. The primary objective is to compare postoperative pain scores (NRS) at various time points within the first 24 hours. Secondary objectives include evaluating the need for rescue analgesia, total tramadol consumption, and the incidence of opioid-related side effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lateral Quadratus Lumborum Block

    Procedure/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.

  • Transversalis Fascia Plane Block

    Procedure/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.

  • Port Site Infiltration

    Procedure/Surgery

    Local infiltration of 20 mL of 0.25% bupivacaine at the trocar insertion sites.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Group QLBExperimental treatment 1 intervention
Group B: Group TFPExperimental treatment 1 intervention
Group C: Group ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Numeric Rating Scale (NRS) Pain Score

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.

Time frame
At 0, 3, 6, 12, 18, and 24 hours postoperatively.

Secondary outcomes

1

Total Tramadol Consumption

The cumulative dose of intravenous tramadol (in milligrams) administered as rescue analgesia.

Time frame
During the first 24 hours postoperatively.
2

Need for Rescue Analgesia

The number of patients requiring rescue analgesia (tramadol 100 mg IV) when the NRS score is ≥ 4.

Time frame
During the first 24 hours postoperatively
3

Incidence of Opioid-Related Side Effects

The number of patients experiencing postoperative nausea, vomiting, or sedation.

Time frame
During the first 24 hours postoperatively.
4

Incidence of Block-Related Complications

The number of patients experiencing complications related to the regional block application, such as hematoma, infection, or local anesthetic systemic toxicity (LAST).

Time frame
During the first 24 hours postoperatively.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medipol University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: