NCT06664177

Brief Summary

It is planned to compare the postoperative analgesic efficacy of the Transversalis Fascia Plane Block and the anterior Quadratus Lumborum Block in elective inguinal hernia surgeries.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Nov 2024Sep 2026

First Submitted

Initial submission to the registry

October 27, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2026

Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

October 27, 2024

Last Update Submit

July 3, 2026

Conditions

Keywords

quadratus lumborum blockTransversalis Fascia Plane Blockinguinal hernia

Outcome Measures

Primary Outcomes (1)

  • time to first rescue analgesic requirement.

    Our primary aim is to compare and evaluate the time to first rescue analgesic requirement after the application of anterior Quadratus Lumborum Block and Transversalis Fascia Plane Block in patients undergoing elective inguinal hernia surgeries under spinal anesthesia.

    24 hour

Secondary Outcomes (2)

  • Total Opioid Consumption

    24 hour

  • To compare the NRS (Numering rating scale) values (resting and dynamic) at 2. 4. 8. 12 . 24. hours in the postoperative follow-up of the patients

    24 hour

Study Arms (2)

anterior quadratus lumborum block

ACTIVE COMPARATOR

The anterior QLB block will be applied on the operative side

Procedure: Anterior Quadratus Lumborum Block (QLB)

transversalis fascia group

ACTIVE COMPARATOR

the Transversalis Fascia Block will be applied on the operative side

Procedure: Transversalis Fascia Plane Block

Interventions

In the Transversalis Fascia Block group, the same procedure will be followed as in the Quadratus Lumborum block group, with the ultrasound probe being placed in the same location, and the same in-plane technique will be applied using a 22G, 100 mm peripheral block needle. The needle tip will be advanced through the posterior aponeurotic extension (tail) of the transversus abdominis muscle to the transversalis fascia plane, immediately superficial to the perinephric fat. After hydrodissection confirms correct needle placement, 20 mL of 0.25% bupivacaine will be injected slowly.

transversalis fascia group

In the Quadratus Lumborum block group, in the lateral decubitus position, a convex ultrasound probe will be sterilely placed in the subcostal area and above the iliac crest. The quadratus lumborum and psoas major muscles, as well as the L4 vertebra's transverse process, will be visualized. Using the in-plane technique and a 22G 100 mm peripheral block needle, the placement will first be identified through hydrodissection in the subfascial area between the quadratus lumborum and psoas major muscles. After localization, 20 mL of 0.25% bupivacaine will be injected slowly, aspirating every 5 cc, while visualizing the local anesthetic pushing the fascia in the ultrasound image.

anterior quadratus lumborum block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18-65
  • ASA Classification 1-2

You may not qualify if:

  • Allergy to local anesthetics
  • Presence of infection at the procedure site
  • BMI \> 35 kg/m²
  • Bleeding disorders or anticoagulant use
  • Chronic analgesic or opioid use
  • Mental or psychiatric disorders
  • ASA Classification 3-4 patients(Severe COPD, history of cerebrovascular events, liver and kidney disease will be excluded from the study.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Research and Training Hospital

Istanbul, 34255, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Abdelbaser I, Mageed NA, El-Emam EM, ALseoudy MM, Elmorsy MM. Preemptive analgesic efficacy of ultrasound-guided transversalis fascia plane block in children undergoing inguinal herniorrhaphy: a randomized, double-blind, controlled study. Korean J Anesthesiol. 2021 Aug;74(4):325-332. doi: 10.4097/kja.20601. Epub 2020 Dec 14.

  • Samerchua A, Leurcharusmee P, Panichpichate K, Bunchungmongkol N, Wanvoharn M, Tepmalai K, Khorana J, Chantakhow S. A Prospective, randomized comparative study between ultrasound-guided posterior quadratus lumborum block and ultrasound-guided ilioinguinal/iliohypogastric nerve block for pediatric inguinal herniotomy. Paediatr Anaesth. 2020 Apr;30(4):498-505. doi: 10.1111/pan.13837. Epub 2020 Feb 21.

  • Ahmed A, Fawzy M, Nasr MAR, Hussam AM, Fouad E, Aboeldahb H, Saad D, Osman S, Fahmy RS, Farid M, Waheb MM. Ultrasound-guided quadratus lumborum block for postoperative pain control in patients undergoing unilateral inguinal hernia repair, a comparative study between two approaches. BMC Anesthesiol. 2019 Oct 17;19(1):184. doi: 10.1186/s12871-019-0862-z.

MeSH Terms

Conditions

Pain, PostoperativeHernia, Inguinal

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsHernia, AbdominalHerniaPathological Conditions, Anatomical

Study Officials

  • Serpil Sehirlioglu, MD

    Gaziosmanpasa Research and Education Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

serpil Sehirlioglu, MD

CONTACT

DÖNDÜ GENÇ MORALAR, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal invertigator

Study Record Dates

First Submitted

October 27, 2024

First Posted

October 29, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 10, 2026

Last Updated

July 7, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

The data associated with the paper are not publicly available but are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
always
Access Criteria
drserpilsahin@gmail.com

Locations