Health TrialsbyHealthPanel

Transversalis Fascia Plane Block for Laparoscopic Inguinal Hernia Repair

ConditionsLaparoscopic Inguinal Hernia RepairAcute Post Operative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstanbul Medipol University Hospital

About this trial

Transversalis Fascia Plane Block (TFPB) is a trunk block that blocks the T12- L2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall. The block's positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open-technique inguinal hernia repair.

This study aimed to investigate the effectiveness of ultrasound (US) guided TFPB on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists (ASA) classification I- II Patients

Unilateral Inguinal Hernia Repair Surgery

Elective Operations

Disqualifiers

Patients with a history of chronic pain

Evidence of infection in the intervention area

Allergy to local anesthetics

Coagulopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transversalis Fascia Plane Block

    Procedure/Surgery

    After the wound closure is completed and the patient is still under general anesthesia the TFPB will be performed. As the patient is in the supine position, the high-frequency linear US probe (11-12 MHz, Vivid Q) and a 22-G 80-mm needle (Stimuplex® Ultra 360®, Braun, USA) will be placed longitudinally, 2-3 cm laterally, just above the iliac crest at the mid-axillary line. After the external oblique, internal oblique, and transversus abdominis muscles are distinguished, the common aponeurosis of the transversus abdominis and the internal oblique muscle will be found. The block needle will be directed from anterior to posterior, using an in-plane technique, the block needle will be advanced and the block location will be confirmed by injecting 5 ml of saline. Once the block location is confirmed, 30 ml of 0.25% bupivacaine (Buvicaine, Polifarma ®) will be applied between the transversus abdominis muscle and transversalis fascia.

  • Post Operative Pain Management

    Procedure/Surgery

    Acetaminophen 1 gr (Paracerol, Polifarma®) intravenous (IV), and tramadol (Contramal, Abdi İbrahim®) 100 mg IV will be administered to all patients 30 minutes before wound closure. After surgery, Acetaminophen (Paracerol, Polifarma®) 1 gr IV, and tramadol (Contramal, Abdi İbrahim®) 100 mg IV will be given three times a day. Another anesthesiologist will assess patients after surgery. If the patient's pain score (NRS) is 4 or higher, IV pethidine (Aldolan, Liba Laboratory ®) 0,5 mg/kg will be given as a rescue analgesic.

  • Port Site Infiltration

    Procedure/Surgery

    A total of 20 ml of 0.25% bupivacaine ( (Buvicaine, Polifarma ®) will be applied to the trocar entry points by the surgeon at the beginning of the operation, before entering the trocars.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group T = TFPB groupExperimental treatment 3 interventions
Group B: Group K = Control groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Rescue analgesic use

The primary aim is to compare the rescue analgesia amount and its time used in the postoperative 24-hour period

Time frame
Need for rescue analgesics at 1, 3, 6, 12,18, and 24 hours postoperatively.

Secondary outcomes

1

Compare postoperative pain scores (NRS scores)

The secondary aim is to compare the pain scores at rest and with movement. Postoperative pain assessment will be performed using the Numerical Rating Scale (NRS) (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded. Low NRS is associated with better pain control.

Time frame
NRS scores at rest and while moving will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively.
2

Side effects and complications

To evaluate block-related complications and side effects (allergic reaction, nausea, vomiting)- block or opioid related

Time frame
Side effects and complications will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively

Other outcomes

Sponsors and contacts

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

Istanbul Medipol University Hospital

Lead sponsor

Source ClinicalTrials.gov
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