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

NCT06815146 | Not Yet Recruiting

• 1 other identifier: 2025
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Opioid Consumption; Quality of Recovery(QoR-40), Preoperative and Postoperative

Keywords

opioid consumption; quality of recovery

Outcome Measures

Primary Outcomes (1)

• postoperative opioid consumption

  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 Outcomes (1)

• quality of recovery

  24 hours

Study Arms (2)

esp block

ACTIVE COMPARATOR

Diagnostic Test: Numeretic rating scale (NRS); Diagnostic Test: Quality of Results (QoR-40); Other: Opioid consuption

mtp block

EXPERIMENTAL

Diagnostic Test: Numeretic rating scale (NRS); Diagnostic Test: Quality of Results (QoR-40); Other: Opioid consuption

Interventions

Numeretic rating scale (NRS) DIAGNOSTIC_TEST

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.

esp block; mtp block

Quality of Results (QoR-40) DIAGNOSTIC_TEST

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.

esp block; mtp block

Opioid consuption OTHER

Opioid consuption will be recorded from PCA

esp block; mtp block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Refusal at enrollment
• Request for withdrawal from the study
• Inability to give informed consent
• Emergency surgery
• Bleeding diathesis
• Presence of contraindications to the LA agents used in this study
• Use of chronic opioids
• Psychiatric disorders
• Presence of infection at the injection site

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Related Publications (1)

• Eskin MB, Ceylan A, Ozhan MO, Atik B. Ultrasound-guided erector spinae block versus mid-transverse process to pleura block for postoperative analgesia in lumbar spinal surgery. Anaesthesist. 2020 Oct;69(10):742-750. doi: 10.1007/s00101-020-00848-w. Epub 2020 Sep 21.

  PMID: 32955601 BACKGROUND

Central Study Contacts

Sinem Sarı, Prof Dr

CONTACT

90 256 220 2108; sarisinem@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Blind patients and postoperative follow-ups will not know which group the patient is in the study. Randomization will be done with computer support.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Prof

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 7, 2025
• Study Start: February 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 15, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02