Comparison of Analgesic Efficacy ESP Block and QLB II in Kidney Transplantation

October 25, 2024 updated by: Muharrem Baturu, University of Gaziantep

Comparison of Intraopertaive and Postoperative Analgesic Efficacy of Ultrasound-guided Quadratus Lumborum II and Errector Spinae Plane Block in Patients Undergoing Kidney Transplantation

Renal transplantation is an increasingly common surgery in recent years. Opioid and/or NSAID use is common in postoperative pain management. However, these drugs have many side effects. Peripheral blocks provide more effective analgesia both intra and postoperatively, and also reduce the use of systemic drugs. The aim of this study was to compare the effects of two different nerve blocks (ESP vs QLB II) on intraoperative remifentanil dose and postoperative analgesia.

Study Overview

Detailed Description

All patients participating in this study underwent a standard anesthesia induction and maintenance. When the patients arrived in the operating room, noninvasive blood pressure, heart rate, electrocardiogram, and oxygen saturation monitoring were performed. Intravenous administration of 2-3 mg/kg propofol, 1-2 mcg/kg Fentanyl, and 0.1 mg/kg atracurium was performed for general anesthesia induction, and then the patients were intubated. After tracheal intubation, anesthesia was maintained with 50% oxygen/air and sevoflurane. An additional 0.1 mg/kg atracurium was added during the surgery as needed. Analgesia was provided with 0.1-0.3 mcg/kg/h intravenous infusion of remifentanil, which was increased or decreased according to the patient's hemodynamics. Intravenous neostigmine was administered for neuromuscular recovery after the surgery. The patient awoke from general anesthesia. Total anesthesia duration, hemodynamic data, and remifentanil dose were recorded.

Patients who would receive a block after general anesthesia induction were randomly determined. These patients were placed in the lateral decubitus position and ESP block or QLB II was applied under ultrasound guidance and echogenic needle (Techniplex 18 gauge; 100 mm needle, Vygon value life) under aseptic conditions. All interventions were performed by an experienced anesthesiology specialist. All procedures were performed under ultrasound guidance using a linear probe (Logiq e GE 12L-RS linear probe, GE LOGIQ e Ultrason device). Patients were randomly divided into 3 groups. Patients who underwent ESB were named Group E, those who underwent QLB were named Group Q, and patients who did not receive a block were named the control group.

The QL block II was done under aseptic technique, in lateral position with the side intended to block side up. A high frequency ultrasound linear probe covered in sterile sheath was placed anterior and superior to the iliac crest. The three anterior abdominal muscles were visualized. The external oblique muscle was followed posterolaterally until its posterior border was identified. Subsequently, the probe was tilted towards the attachment site of both the internal and external oblique muscles over the quadratus (QL) muscle until the midline of the thoracolumbar fascia was seen as a bright hyperechogenic line located between the posterior border of the quadratus lumborum muscle and the middle thoraco-lumbar fascia (anterior to latissiumus dorsi and erector spinae muscles). A 22-gauge Facet-tip SonoPlex needle of appropriate length estimated from the depth and length of required needle trajectory during scout scanning was inserted via in-plane technique. The needle was directed from anterolateral to posteromedial after making a negative aspiration test with aliquots of 0.5 ml saline to confirm hydrodissection in the lumbar interfascial triangle (LIFT) between the QL muscle and middle thoracolumbar fascia. An injection of LA was given according to the group allocated. Aliquots of LA with intermittent aspiration during injection was performed in the desired confirmed space After the needle tip was correctly positioned, 10 ml of bupivacaine and 10 ml of 0.9% saline solution were injected.

For ESP, high frequency linear ultrasound probe was planned transversely to the midline and spinous features were visualized. Cervical C7 and T7 vertebrae at the lower end of the scapula, which were accepted as landmarks, were determined and marked with a sterile surgical drawing pen. According to these landmarks, the USG probe was moved 2-3 cm laterally towards the points where kidney transplantation was planned at the T10 vertebral level, and the transverse parts, trapezius, latissimus dorsi, serratus and erector spina muscles were visualized. Using the block needle that can be visualized on USG with in-plane surgery, the skin, subcutaneous tissue and trapezius, latissimus dorsi, serratus and erector spina muscles were passed in a cranio caudal direction and the needle location was confirmed by hydrodissection with 2-5 ml of serum. The distribution of the block procedure and the spread of local anesthetic were linearly visualized with 10 ml bupivacaine and 10 ml 0.9% saline.

The control group received 0.1 mg/kg morphine subcutaneously 30 minutes before the end of the operation. All patients were connected to a patient-controlled analgesia device (1 mg Fentanyl/100 ml saline, 2 ml bolus dose, 15 min lock, infusion rate 2 ml/h).

Postoperatively, total 24-hour fentanyl consumption and pain scores of all patients were recorded according to the visual analog scale at 1, 2, 3, 4, 6, 12 and 24 hours.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gaziantep, Turkey, 27031
        • University of Gaziantep

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

-

Exclusion Criteria:

Patients with a history of allergy to general and local anesthetics to be used, inability to understand or participate in pain scoring, inability to use the PCA pump, or conditions that prevent the performance of trunkal blocks (anatomical or postoperative deformations in the region)

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group E
Group that Erector spinae plane block was applied.
For ESP, high frequency linear ultrasound probe was planned transversely to the midline and spinous features were visualized. Cervical C7 and T7 vertebrae at the lower end of the scapula, which were accepted as landmarks, were determined and marked with a sterile surgical drawing pen. According to these landmarks, the USG probe was moved 2-3 cm laterally towards the points where kidney transplantation was planned at the T10 vertebral level, and the transverse parts, trapezius, latissimus dorsi, serratus and erector spina muscles were visualized. Using the block needle that can be visualized on USG with in-plane surgery, the skin, subcutaneous tissue and trapezius, latissimus dorsi, serratus and erector spina muscles were passed in a cranio caudal direction and the needle location was confirmed by hydrodissection with 2-5 ml of serum. The distribution of the block procedure and the spread of local anesthetic were linearly visualized with 10 ml bupivacaine and 10 ml 0.9% saline.
Active Comparator: Grup Q
Group that Quadratus lumborum type II block was applied
The QL block II was done under aseptic technique, in lateral position with the side intended to block side up. A high frequency ultrasound linear probe covered in sterile sheath was placed anterior and superior to the iliac crest. The three anterior abdominal muscles were visualized. The external oblique muscle was followed posterolaterally until its posterior border was identified. Subsequently, the probe was tilted towards the attachment site of both the internal and external oblique muscles over the quadratus (QL) muscle until the midline of the thoracolumbar fascia was seen as a bright hyperechogenic line located between the posterior border of the quadratus lumborum muscle and the middle thoraco-lumbar fascia (anterior to latissiumus dorsi and erector spinae muscles). A 22-gauge Facet-tip SonoPlex needle of appropriate length estimated from the depth and length of required needle trajectory during scout scanning was inserted via in-plane technique. The needle was directed from a
No Intervention: Group K
no block was applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of postoperative analgesia
Time Frame: postoperative 24 hours
visuel analog score < 3
postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
consumption of add analgesic dos
Time Frame: postoperative 24 hours
Reduction in consumption of additional analgesic administered (fentanyl PCA)
postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ESB vs QLB in transplatation
  • 2022/172 (Other Identifier: University of gaziantep clinical research ethics committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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