The Effects of ESP Block and Mid-Transverse Process to Pleura Block on Postoperative Opioid Consumption and Quality of Recovery

February 3, 2025 updated by: SINEM SARI, Aydin Adnan Menderes University

Comparison of the Effects of Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) on Postoperative Opioid Consumption and Quality of Recovery in Lumbar Spinal Surgery

Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) have recently been described for the treatment of pain after lumbar spinal surgery. Although these blocks have been shown to be effective in the treatment of pain after lumbar spinal surgery when compared with postoperative pain, they have not been compared in terms of the quality of recovery and opioid consumption after lumbar spinal surgery.

The aim of this clinical trial is to compare the effects of Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) on quality of recovery and opioid consumption in patients scheduled for lumbar spinal surgery. The effects of the 2 blocks on postoperative pain will also be compared and recorded.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

126

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 Contact

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

No

Description

Inclusion Criteria:

  • Elective Lumbar Spinal surgery performed
  • ASA I-III
  • 18-75 years old

Exclusion Criteria:

  1. Refusal at enrollment
  2. Request for withdrawal from the study
  3. Inability to give informed consent
  4. Emergency surgery
  5. Bleeding diathesis
  6. Presence of contraindications to the LA agents used in this study
  7. Use of chronic opioids
  8. Psychiatric disorders
  9. Presence of infection at the injection site

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: esp block
Diagnostic test: Numeretic rating scale (NRS)
NRS is a pain intensity determination system based on the person being asked to describe their pain on a scale of 0 (none), 10 (unbearable pain) and a point between.
Diagnostic test: Quality of Results (QoR-40)
Several rating scales have been developed to measure quality of recovery after surgery and anaesthesia, but the most extensively used is the QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain.
Other: Opioid consuption
Opioid consuption will be recorded from PCA
Experimental: mtp block
Diagnostic test: Numeretic rating scale (NRS)
NRS is a pain intensity determination system based on the person being asked to describe their pain on a scale of 0 (none), 10 (unbearable pain) and a point between.
Diagnostic test: Quality of Results (QoR-40)
Several rating scales have been developed to measure quality of recovery after surgery and anaesthesia, but the most extensively used is the QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain.
Other: Opioid consuption
Opioid consuption will be recorded from PCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative opioid consumption
Time Frame: PCA results will be recorded at the 1st, 6th, 12th, 24th hours postoperatively.
The patient will be administered tramadol PCA every eight hours and recorded.
PCA results will be recorded at the 1st, 6th, 12th, 24th hours postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of recovery
Time Frame: 24 hours
The quality of recovery (QoR-40) of patients who underwent both ESP block and MTP block at the 24th hour postoperatively will be evaluated with a scoring system.
24 hours

Collaborators and Investigators

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

Sponsor

Aydin Adnan Menderes University

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 (Estimated)

February 15, 2025

Primary Completion (Estimated)

February 15, 2026

Study Completion (Estimated)

February 15, 2026

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025 (Other Grant/Funding Number: Fondation de l'Hôtel-Dieu de Lévis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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