Comparison of Postoperative Analgesic Efficacy of Transversalis Fascia Plan Block and Erector Spina Plan Block

November 9, 2022 updated by: Hale Kefeli Celik, Samsun Education and Research Hospital
The subject of the study is to compare the analgesic efficacy of transversalis fascia plan block and erector spina plane block applied with ultrasonography in patients who have undergone inguinal hernia operation. The aim of the study is to compare two different regional anesthesia methods applied in the postoperative period in terms of 24-hour opioid consumption, pain scores, additional analgesic need, and side effects and complications in the postoperative period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An identification number (ID) number will be randomly assigned to each patient, whose written consent was obtained before the surgery, when they are admitted to the postoperative recovery room. In the postoperative period, patients will be followed up with these numbers in patient follow-up. Which group the patients will be included in will be determined by the closed envelope method.

The anesthetist, who will perform the regional block, will give the block to be applied in a sealed envelope by an assistant staff outside the study, and at the same time, the patient will not know which block has been made. The anesthesiologist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another investigator blinded to the study.

Spinal anesthesia will be applied to all patients and inguinal hernia operation will be appropriate. Patients taken to the recovery room will be divided into two groups. Transversalis fascia plan block (Group T) will be applied to the patients in a group after local cleansing of the skin area, accompanied by ultrasonography. The patients in the other group will be treated with an erector spina plane block (Group E) following local cleansing of the skin area, accompanied by ultrasonography.

In both block management, 0.25% bupivacaine (Buvasin Vem İlaç, Turkey) (15 ml physiological saline + 15 ml 0.5% bupivacaine) total amount of 30 ml, same volume and same concentration will be used.

After the block procedure, the patient will be observed in the recovery room for side effects. Patient-controlled analgesia (PCA) will be used as a standard in the treatment of postoperative pain in patients in both groups without any complications. Tramadol HCL, which is routinely used for postoperative pain control for PCA, will be used (3 mg/ml, total volume 100 mL).

Evaluation of postoperative pain will be done with numerical rating scale (NRS).Pain levels will be questioned in two different ways as rest and cough.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

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

  • Turkey
      • Samsun, Turkey, 55090
        • Samsun Research and Education Hospital

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Those who underwent unilateral inguinal hernia surgery under elective conditions
  • 18-65 years
  • ASA I-III
  • Patients with written consent who agreed to participate in the study

Exclusion Criteria:

  • Body mass index > 35 kg/m²,
  • Coagulopathy and local infection or hematoma in the area to be blocked,
  • Allergic to a local anesthetic agent or one of the drugs used in the study,
  • Those with a history of chronic opioid and corticosteroid use,
  • Unable to use the patient-controlled analgesia system,
  • Those with psychiatric illness,
  • Cases with a surgical time of less than 30 minutes and more than 120 minutes for better standardization of studies,
  • Patients who do not agree to participate in the study will not be included in the study.

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transversalis fascia plan block (Group T)
After local cleaning of the skin area, the transducer will be placed on the iliac crest in the transverse plane with a low-frequency convex probe, and the skin, subcutaneous tissue, external oblique muscle will be placed with a 20 G, 100 mm needle. After visualization of the internal oblique muscle and transversus abdominis muscles and finally the deep fascia of the transversus abdominis, local anesthetic will be given unilaterally between the last part of the transversus abdominis muscle and the transversalis fascia with the out-off plan technique.
Device: Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy)
A low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy) device will be used while blocking in both groups.
Active Comparator: Erector spina plan block (Group E)
After local cleaning of the skin area, a convex probe is determined to be placed longitudinally 3 cm lateral to the spinous process of the T11 vertebra, after determining the erector spina muscle, with a 20 G, 100 mm needle inplane method in the craniocaudal direction will be advanced and a local anesthetic will be administered between the erector spinae muscle and the transverse process.
Device: Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy)
A low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy) device will be used while blocking in both groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid use
Time Frame: Postoperative 24 hours
To determine the amount of analgesic consumption in the postoperative first 24 hours with PCA in the postoperative period.
Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale
Time Frame: Postoperative 24 hours
To determine the pain of the patients at rest and coughing at the 1st, 3rd, 6th, 12th, 18th and 24th hours postoperatively with Numerical Rating Scale (NRS).The NRS is a segmented numerical version in which the respondent selects an integer (0-10) that best reflects the intensity of their pain. 0: no pain 1-3: mild pain 4-6: moderate pain 7-10: severe pain.
Postoperative 24 hours

Collaborators and Investigators

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

Sponsor

Samsun Education and Research Hospital

Investigators

  • Study Chair: Mustafa Süren, Professor, Samsun Research and Education Hospital

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.

General Publications

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)

May 5, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SIMAY55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Researched data and statistical analyzes will be available from the journal in which the clinical study was published.

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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