Clinical trial NCT04026243: Ultrasound-Guided Transversalis Fascia Plane Block Versus Transmuscular Quadratus Lumborum Block for Post-operative Analgesia in Inguinal Hernia Repair
Official title: Ultrasound-Guided Transversalis Fascia Plane Block Versus Transmuscular Quadratus Lumborum Block for Post-operative Analgesia in Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management of Inguinal Herniorrhaphy
Keywords: ultrasound guided regional blocks
Transversalis Fascia Plane Block
Quadratus Lumborum Block
inguinal herniorrhaphy
Pain management
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Regional blocks as a part of multimodal analgesia can improve pain control in the postoperative period. The transversalis fascia plane (TFP) block can block the proximal portions of the T12 and L1 nerves, while the main advantage of the Quadratus Lumborum (QL) block is the possible extension of the local anesthetic beyond the transversus abdominis plane (TAP) plane spreading into the thoracic paravertebral space and anesthetizing both the lateral and anterior cutaneous branches from T7 to L1. the aim of this study is to compare effectiveness of ultrasound-guided transversalis fascia plane block to trans-muscular quadratus lumborum block in providing postoperative analgesia in patients undergoing unilateral inguinal hernia repair.

Detailed description: This prospective randomized controlled study will include 50 patients (25 in each group) of American Society of Anesthesiologist (ASA) I and II physical status who will undergo unilateral inguinal herniorrhaphy under general anesthesia. The investigators hypothesize that ultrasound-guided trans-muscular quadratus lumborum block will be more effective than ultrasound guided transversalis fascia plane block in providing postoperative analgesia in these type of patients. Randomization will be done by a computer-generated random numbers. Patients will be blinded to the study groups. All patients will undergo a thorough pre anesthetic check-up and will be premedicated with metoclopramide 10 mg intravenously.

In the operation theatre, an 18-gauge intravenous (IV) catheter will be placed and monitoring devices will be attached which will include electrocardiograph (ECG) using (GE-Datex Ohmeda 5 lead ECG cable), pulse oximetry (SpO2) using (GE- Datex Ohmeda adult finger spO2 sensor), non-invasive blood pressure (NIBP) using (GE-Datex Ohmeda NIBP cuff, adult double tube with bag). Emergency drugs and equipment will be ready and prepared. Numeric pain rating scale will be explained clearly to all patients before conduction of anesthesia.

Anesthesia will be induced with fentanyl (2 mcg/kg) and propofol (1.5-2.5 mg/kg) and atracurium besylate (0.5 mg/Kg). An endotracheal tube will be inserted, and controlled ventilation will be adjusted to maintain normocapnia. Anesthesia will be maintained with sevoflurane at 1% and boluses of atracurium (0.1 mg/Kg) every 30 min. All patients will be given 1 g intravenous paracetamol, together with 4 mg ondansetron 10 min prior to the end of surgery for postoperative nausea and vomiting prophylaxis.

The patients will be classified into two equal groups; Group QL (n=25) and group TF (n=25).

All blocks will be performed on patients, following general anesthesia induction and endotracheal tube insertion, under guidance of a digital ultrasonic diagnostic imaging system (Mindray®, china), using a low frequency (2-6 MHz) curvilinear probe and a 100-150-mm short-bevel echogenic needle. Before ultrasound scanning, the operator will wear sterilized gown and gloves following routine scrubbing, flank skin will be prepared by antiseptic solution and fenestrated drape and dressings will be used for all procedures. After surgical disinfection of ipsilateral flank and protection of the ultrasound probe with a sterile ultrasound probe cover, sterile gel will be applied prior to scanning.

After skin closure, inhalational anesthesia will be discontinued and reversal of muscle relaxation with atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) will be administered IV after return of patient's spontaneous breathing. Patient will then be transferred to post anesthesia care unit (PACU) for complete recovery and monitoring.

In the PACU; rescue analgesia in the form of intravenous nalbuphine (in 5 mg increments) will be given for a numerical pain score more than 4 in the immediate postoperative period.

The block will be considered a failed block if the patient required more than one 5mg dose of nalbuphine in the first hour postoperatively.

In the ward; rescue analgesia will be given in the form of intravenous nalbuphine (in 5 mg increments) and repeated if needed every half an hour with a maximal dose of 60 mg in 24 hours.

Eligibility criteria: Inclusion Criteria:

* All consecutive patients of ASA classification grade I and II,
* aged above 18 years old and less than 65 years old,
* of both sexes,
* body mass index (BMI) below 35,
* who had a capacity to rate pain on a numeric rating scale (NRS) of 0 to --underwent non-recurrent unilateral inguinal hernia repair

Exclusion Criteria:

* patient refusal
* patient aged \< 18 or \> 65 years old,
* ASA classification \> II, BMI \< 35
* those with previous difficulty in evaluating their level of pain
* any contraindications for local anesthesia as: patient refusal of local anesthesia injection, coagulopathy( defined as either thrombocytopenia (platelet count below 100,000 platelets per microliter and/or prothrombin time greater than 14 seconds ), therapeutic anticoagulation, presence of skin infection or hematoma in the vicinity of the puncture site or those with known allergy to any of the study drugs

Primary outcomes:
measure: postoperative numeric pain rating scale (NRS) from 0 to 10
timeFrame: Measured at 30 minutes postoperatively.
Secondary outcomes:
measure: postoperative numeric pain rating scale (NRS) from 0 to 10
timeFrame: Measurements at 10 minutes, 30 minutes, 60 minutes and 90 minutes after surgery, and at 24 hours postoperatively
measure: number of increments of rescue analgesia
timeFrame: from 30 mintes up to 24 hours postoperative
measure: level of sensory block in the immediate postoperative period
timeFrame: 10 minutes after PACU admission
measure: Easiness of performance of the block
timeFrame: once during block performance
measure: Block performance time in minutes
timeFrame: from U/S probe contact with skin till needle withdrawal up to 30 minuteas afteintubation
measure: Patient satisfaction regarding pain management
timeFrame: rated 6 hours after surgery
measure: incidence of adverse effects,
timeFrame: postoperative up to 24 hours
measure: Failure rate of the block
timeFrame: in the first hour postoperatively
Other outcomes:
measure: heart rate (HR)
timeFrame: up to 60 minutes after removal of endotracheal tube
measure: systolic blood pressure (SBP)
timeFrame: up to 60 minutes after removal of endotracheal tube
measure: mean arterial blood pressure (MAP)
timeFrame: up to 60 minutes after removal of endotracheal tube
measure: Duration of surgery
timeFrame: time from skin incision till skin closure up to 180 minutes after GA induction
measure: Duration of general anesthesia
timeFrame: time from induction of GA till removal of endotracheal tube up to 18 minutes after GA induction
Locations:
city: Giza
country: Egypt
facility: Hany Mohammed El-Hadi Shoukat Mohammed
Study officials:
affiliation: www.kasralainy.cu.edu.eg
name: Hany MES Mohammed, MD
role: PRINCIPAL_INVESTIGATOR
References: