NCT06664164

Brief Summary

Evaluation of Postoperative Analgesic Efficacy of Adjuvant Use in Quadratus Lumborum Blocks

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

9 months

First QC Date

October 27, 2024

Last Update Submit

August 21, 2025

Conditions

Keywords

anterior quadratus lumborum blockpostoperative painadjuvantdexamethasoneinguinal hernia

Outcome Measures

Primary Outcomes (1)

  • time to first rescue analgesic requirement.

    Compare the time to first rescue analgesia in patients

    24 hour

Secondary Outcomes (3)

  • Total analgesic Consumption

    24 hour

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

    24 hour

  • To compare postoperative side effects such as nausea, vomiting

    24 hour

Study Arms (2)

QLB Group

ACTIVE COMPARATOR

anterior quadratus lumborum block group

Procedure: ANTERİOR QUADRATUS LUMBORUM BLOCK

adjuvant QLB Group

ACTIVE COMPARATOR

with adjuvant anterior quadratus lumborum block group

Procedure: ANTERİOR QUADRATUS LUMBORUM BLOCK WİTH ADJUVANT

Interventions

Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected.

QLB Group

Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 8 mg de-xamethasone are injected.

adjuvant QLB Group

Eligibility Criteria

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

You may not qualify if:

  • local anesthetic allergy
  • Infection at the procedure site
  • Body Mass Index \>35 kg/m2
  • Anticoagulant use with bleeding disorder
  • Chronic analgesia and opioid use -with mental and psychiatric disorders -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Research and Training Hospital

Istanbul, 34255, Turkey (Türkiye)

Location

Related Publications (2)

  • Priyadarshini K, Behera BK, Tripathy BB, Misra S. Ultrasound-guided transverse abdominis plane block, ilioinguinal/iliohypogastric nerve block, and quadratus lumborum block for elective open inguinal hernia repair in children: a randomized controlled trial. Reg Anesth Pain Med. 2022 Apr;47(4):217-221. doi: 10.1136/rapm-2021-103201. Epub 2022 Jan 17.

    PMID: 35039439BACKGROUND
  • Favaro ML, Gabor S, Souza DBF, Araujo AA, Milani ALC, Ribeiro Junior MAF. Quadratus Lumborum Block As A Single Anesthetic Method For Laparoscopic Totally Extraperitoneal (Tep) Inguinal Hernia Repair: A Randomized Clinical Trial. Sci Rep. 2020 May 22;10(1):8526. doi: 10.1038/s41598-020-65604-x.

    PMID: 32444629BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeHernia, Inguinal

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Serpil Sehirlioglu, MD

    Gaziosmanpasa Research and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Everyone except the person preparing the medication for the patient will be blinded. The person performing the block, the participants, and those monitoring during the postoperative period will be blinded to the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 27, 2024

First Posted

October 29, 2024

Study Start

November 1, 2024

Primary Completion

August 12, 2025

Study Completion

August 13, 2025

Last Updated

August 28, 2025

Record last verified: 2025-08

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, ANALYTIC CODE
Time Frame
always
Access Criteria
drserpilsahin@gmail.com

Locations