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

NCT04026243 | Completed

• 1 other identifier: N-48-2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management of Inguinal Herniorrhaphy

Keywords

ultrasound guided regional blocks; Transversalis Fascia Plane Block; Quadratus Lumborum Block; inguinal herniorrhaphy; Pain management

Outcome Measures

Primary Outcomes (1)

• postoperative numeric pain rating scale (NRS) from 0 to 10

  Patient-assessed resting and movement-induced pain on a numeric pain rating scale of 0 to 10 (higher score will be taken).

  Measured at 30 minutes postoperatively.

Secondary Outcomes (8)

• postoperative numeric pain rating scale (NRS) from 0 to 10

  Measurements at 10 minutes, 30 minutes, 60 minutes and 90 minutes after surgery, and at 24 hours postoperatively

• number of increments of rescue analgesia

  from 30 mintes up to 24 hours postoperative

• level of sensory block in the immediate postoperative period

  10 minutes after PACU admission

• Easiness of performance of the block

  once during block performance

• Block performance time in minutes

  from U/S probe contact with skin till needle withdrawal up to 30 minuteas afteintubation

Other Outcomes (5)

• heart rate (HR)

  up to 60 minutes after removal of endotracheal tube

• systolic blood pressure (SBP)

  up to 60 minutes after removal of endotracheal tube

• mean arterial blood pressure (MAP)

  up to 60 minutes after removal of endotracheal tube

Study Arms (2)

QL group (n = 25)

ACTIVE COMPARATOR

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.

Procedure: QL block

TF group (n = 25)

ACTIVE COMPARATOR

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.

Procedure: TF block

Interventions

QL block PROCEDURE

U/S guided Transmuscular Quadratus Lumborum Block

QL group (n = 25)

TF block PROCEDURE

U/S guided Transversalis Fascia Plane Block

Also known as: TFP block

TF group (n = 25)

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hany Mohammed El-Hadi Shoukat Mohammed

Giza, 12211, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hany MES Mohammed, MD

  www.kasralainy.cu.edu.eg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia, pain management and SICU

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 19, 2019
• Study Start: January 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 31, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)