Ultrasound-Guided Transversalis Fascia Plane Block Versus Transmuscular Quadratus Lumborum Block for Post-operative Analgesia in Inguinal Hernia Repair

NCT ID: NCT04026243

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-08-31

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.

Conditions

Pain Management of Inguinal Herniorrhaphy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

QL group (n = 25)

After general anesthesia (GA), patient will be placed in lateral position with side to be anesthetised upwards. U/S probe will be placed in the transverse plane at the abdominal flank immediately cranial to the iliac crest. Then moved dorsally until the QL muscle is identified with its attachment to lateral edge of the transverse process of the L4 vertebral body with identification of shamrock sign. The needle is inserted in-plane to transducer (lateral edge) and tip of needle is advanced through the QL muscle. Once the tip of the needle correctly placed and confirmed by negative aspiration, 2 ml of normal saline will be instilled to confirm correct separation of the plane. Following this, 30 ml of 0.25% bupivacaine will be injected between the QL and psoas major.

Group Type: ACTIVE_COMPARATOR

QL block

Intervention Type: PROCEDURE

U/S guided Transmuscular Quadratus Lumborum Block

TF group (n = 25)

After GA, patient will be placed in lateral position with side to be anesthetised upwards. U/S probe will be placed in midaxillary line just cephalad to the iliac crest. Scanning anteriorly will identify the three muscles of the anterior abdominal wall. The transversus abdominis typically tapers to form a hyper echoic aponeurosis that passes posterior to quadratus lumborum. Scan will be continued posteriorly to visualize solid organs or viscera deep to the transversus abdominis. The needle will be positioned such that it enters the skin anterior to the ultrasound probe and passes in-plane posterolateral through the three lateral abdominal muscles. Once the tip of the needle correctly placed and confirmed by negative aspiration, 2 ml of normal saline will be instilled to confirm correct separation of the plane. Following this, 30 ml of 0.25% bupivacaine will be injected between the transversus abdominis muscle and the transversalis fascia anterolateral to quadratus lumborum.

Group Type: ACTIVE_COMPARATOR

TF block

Intervention Type: PROCEDURE

U/S guided Transversalis Fascia Plane Block

Interventions

QL block

U/S guided Transmuscular Quadratus Lumborum Block

Intervention Type: PROCEDURE

TF block

U/S guided Transversalis Fascia Plane Block

Intervention Type: PROCEDURE

Other Intervention Names

TFP block

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hany Mohammed El-Hadi Shoukat Mohammed

lecturer of anesthesia, pain management and SICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hany MES Mohammed, MD

Role: PRINCIPAL_INVESTIGATOR

www.kasralainy.cu.edu.eg

Locations

Hany Mohammed El-Hadi Shoukat Mohammed

Giza, , Egypt

Countries

Egypt

Other Identifiers

N-48-2018

Identifier Type: -

Identifier Source: org_study_id