NCT05446727

Brief Summary

Prior to surgery, patients will be stratified into groups according to the type of surgical procedure. The anticipated groups are as follows: Patients with colorectal cancer Patients with prostate cancer Patients with renal cancer Patients undergoing surgery for gallbladder cholelithiasis. The Erector Spinal Block (ESP) is based on the deposition of the local anesthetic in the inter-fascial space between the dorsal extensor muscle and the intercostal muscles at the height of the transverse processes. The scope of the blockade covers the dorsal and ventral branches of the thoracic spinal nerves, but also in most cases the investigetors are able to obtain a wide distribution of the drug into the paravertebral space by "permeating" the local anesthetic through the fascial compartments. The clinical effect of the blockade is due to blocking the nerve structures of the paravertebral space (spinal nerve branches and the sympathetic trunk). The scope of the blockade, after its execution at the level of Th5, most often includes the segments from Th1 to L1. Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the anterior QL block ( QL1 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

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

Study Start

First participant enrolled

May 1, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 4, 2025

Status Verified

June 1, 2023

Enrollment Period

5 days

First QC Date

June 2, 2022

Last Update Submit

August 27, 2025

Conditions

Keywords

AnestheticsLocal Anesthetics

Outcome Measures

Primary Outcomes (1)

  • Total long acting opioid consumption in oxycodone equivalents

    the total dosage of given drug

    1 days

Secondary Outcomes (2)

  • Pain scores will be recorded at intervals. The Numerical Rating Scale (NRS) is an 11-point scale where 0 is no pain and 10 is the worst pain imaginable.

    1 days

  • Incidence of postoperative nausea-vomiting; itching; local anesthetic toxicity;

    1vdays

Study Arms (2)

Quadratus Lumborum block group

EXPERIMENTAL

Experimental: Quadratus Lumborum block group Patients were placed in the lateral decubitus position. After skin disinfection, a linear high-frequency ultrasound probe guarded with a sterile cover was set above the iliac crest and shifted cranially until the three abdominal wall muscles were distinguished. Then, it was moved medially until latissimus dorsi and quadratus lumborum (QLM) muscles were shown within identical short-axis views. A 21-gauge needle was inserted from the edge of the probe using an in-plane technique and advanced into the fascia over the QLM. After ensuring negative aspiration for blood, 30 ml of 0.35% ropivacaine bilateral was injected slowly into the fascial interspace.

Drug: Ropivacaine injection

erector spinae planae block

EXPERIMENTAL

The ESP block was performed with the patient in a sitting position. After skin disinfection, a linear high-frequency (L14-6NS) ultrasound probe, covered with a sterile sheath, was positioned sagittally 1-2 cm lateral to the midline at the level of the ninth thoracic vertebra (T9). The T9 level was earlier identified by palpating the spinous process of the seventh cervical vertebra and counting down nine intervertebral spaces. After identifying the erector spinae muscle (ESM) and transverse process, a 21-gauge needle was inserted deep into the ESM in a cranio-caudal direction, using an in-plane technique. The needle was advanced, ensuring that it crossed all muscle layers until it contacted the transverse process. A total of 60 mL of 0.35% ropivacaine was given. This procedure was performed bilaterally on each patient.

Drug: Ropivacaine injection

Interventions

30ml of 0.35% ropivacaine bilaterally

Quadratus Lumborum block grouperector spinae planae block

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring abdomen surgery
  • Patients of age 18 and over
  • BMI \< 40
  • Patients who are expected to stay in-hospital overnight after surgery

You may not qualify if:

  • Patient refusal
  • Contraindications to paravertebral blocks: Infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, and tumor occupying the thoracic paravertebral space, coagulopathy, bleeding disorder or therapeutic anticoagulation
  • Known allergy to local anesthetics
  • Inability to provide informed consent
  • Inability to use a PCA due to languate or comprehension barriers
  • BMI \>= 40
  • Any patient on opioids for greater than or equal to 3 months duration prior to surgery
  • Patients with chronic pain syndromes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jagiellonian University

Krakow, Maloposkie, 31-501, Poland

Location

Related Publications (1)

  • Tomasz S, Pawel M, Michal C, Szpunar W, Jan S, Tomasz L, Anna K, Renata B, Olga S, Tomasz D, Michal T. Effects of Erector Spinae Plane Block and Quadratus Lumborum Block on Postoperative Opioid Consumption in Laparoscopic Kidney Surgery: A Randomized Controlled Clinical Trial. Pain Res Manag. 2025 Aug 4;2025:8869716. doi: 10.1155/prm/8869716. eCollection 2025.

MeSH Terms

Conditions

Acute PainPain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2022

First Posted

July 7, 2022

Study Start

May 1, 2022

Primary Completion

May 6, 2022

Study Completion

December 31, 2023

Last Updated

September 4, 2025

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations