Comparison of Pain Relief Efficacy of Epidural Analgesia and Erector Spinae Plane Block Before Thoracotomy Surgery

October 3, 2023 updated by: Fatma Acil, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Effectiveness Comparison Of Preemptive Single-Dose Thoracic Epidural Analgesia And Erector Spinae Plane Block For Thoracotomy Analgesia In Thoracic Surgery

In patients who will undergo open thoracic surgery, two different types of drugs will be administered to volunteer patients before surgery in order to relieve postoperative pain, facilitate breathing and reduce hospitalization time. The pain intensity, respiratory capacity, the amount of opioid analgesic needed during and after surgery, side effects such as nausea-vomiting, low blood pressure and shortness of breath will be evaluated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Group Thoracic Epidural Analgesia (TEA): Thoracic Epidural Application: The epidural area will be accessed from the 7th (T7)-8th (T8) level of the thoracic vertebral midline with an 18 gauge (G) epidural needle using the hanging drip technique. After 2 ml of 2% lidocaine is administered and no spinal effect is observed, a mixture of morphine and local anaesthetic 3-4 mg morphine hydrochloride + 5 ml 0.5% bupivacaine + 2 ml 0.9% saline will be administered through the epidural needle at once and the epidural needle will be withdrawn and sterile dressing will be applied.

  • The mode of presentation will be face-to-face and individually.
  • The intervention will be performed by an anaesthetist with at least 5 years of experience.
  • The stages of the intervention will be verbally explained in detail to participants prior to the intervention.
  • The patient will be taken to the operating table and electrocardiographic, oxygen saturation with pulse oximetry and non-invasive blood pressure monitoring with automatic manometer will be performed.

The intervention will be administered only once, 3-4 mg of morphine hydrochloride + 5 ml of 0.5 % bupivacaine + 2 ml of 0.9 % saline into the epidural space.

  • Immediately before induction of anaesthesia, the patient will be seated and after appropriate sterilisation conditions are provided, the thoracic epidural space will be reached and the analgesic mixture will be given once and the space will be exited.
  • Immediately after sterile dressing of the intervention site, the patient will be placed supine and standard general anaesthesia will be applied.
  • The intervention will be performed in the thoracic surgery room of our hospital operating theatre.

Grup Erector spinae plane block (ESP): Before induction of anaesthesia, the patient will be placed on the operating table and placed in a forward tilted position. Asepsis and antisepsis conditions will be fulfilled.

The linear ultrasonogram (USG) probe will first be placed in the sagittal plane to visualise the vertebral spinous process. Then the linear probe was moved approximately 2-3 cm lateral to the spinous process T5 - T6 level on the side to be operated on, and the probe will be rotated 90 degrees to the longitudinal plane to visualise the transverse process. The trapezius, rhomboid major and erector spinae muscles will be identified to find the correct probe position. A 22 gauge, 50 mm or 22 gauge 80 mm single shot nerve blocks needle will be inserted through the skin in a cranio-caudal direction. With the needle resting on the transverse process, the plane between the erector spinae muscle and the transverse process will be verified by hydrodissection with 5 ml saline solution. Then, 20 ml of 0.25% bupivacaine will be injected. The ESP block will be considered successful if the local anaesthetic spreads linearly up to the T8 - T9 level. The patient will then be placed in the supine position and general anaesthesia will be administered.

  • The mode of presentation will be face-to-face and individually.
  • The intervention will be performed by an anaesthetist with at least 5 years of experience.
  • The stages of the intervention will be verbally explained in detail to participants prior to the intervention.
  • The patient will be taken to the operating table and electrocardiographic, oxygen saturation with pulse oximetry and non-invasive blood pressure monitoring with automatic manometer will be performed.
  • The intervention will be performed only once on the side of the surgical incision and 20 ml of 0.25% bupivacaine will be injected once into the relevant area.
  • Immediately before induction of anaesthesia, the patient will be seated and after appropriate sterilisation conditions are provided, the fascia of the erector spina muscle will be reached under ultrasound guidance and the analgesic solution will be given to this area only once and the cavity will be exited.
  • Immediately after sterile dressing of the intervention site, the patient will be placed supine and standard general anaesthesia will be applied.
  • The intervention will be performed in the thoracic surgery room of our hospital operating theatre.

Study Type

Observational

Enrollment (Estimated)

42

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

Study Locations

  • Turkey
      • Diyarbakır, Turkey, 21070
        • Recruiting
        • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
        • 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

Sampling Method

Probability Sample

Study Population

patients undergoing thoracotomy surgery

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) I-III physical condition
  • who were to undergo thoracotomy

Exclusion Criteria:

  • patients with acute infection,
  • coagulation disorder,
  • morbid obesity (Body Mass Index (BMI) > 35),
  • drug allergy
  • history of chronic pain,
  • long-term opioid use,
  • history of psychiatric illness,
  • emergency surgeries

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group TEA (Thoracic Epidural Analgesia)
Group TEA (Thoracic Epidural Analgesia): Thoracic Epidural Application: The epidural area will be accessed from the 7th (T7)-8th (T8) level of the thoracic vertebral midline with an 18 gauge (G) epidural needle using the hanging drip technique. After 2 ml of 2% lidocaine is administered and no spinal effect is observed, a mixture of morphine and local anaesthetic 3-4 mg morphine hydrochloride + 5 ml 0.5% bupivacaine + 2 ml 0.9% saline will be administered through the epidural needle at once and the epidural needle will be withdrawn and sterile dressing will be applied.
Procedure: Thoracic Epidural Analgesia
Thoracic Epidural Application: The epidural area will be accessed from the 7th (T7)-8th (T8) level of the thoracic vertebral midline with an 18 gauge (G) epidural needle using the hanging drip technique. After 2 ml of 2% lidocaine is administered and no spinal effect is observed, a mixture of morphine and local anaesthetic 3-4 mg morphine hydrochloride + 5 ml 0.5% bupivacaine + 2 ml 0.9% saline will be administered through the epidural needle at once and the epidural needle will be withdrawn and sterile dressing will be applied.
Grup ESP ( Erector spinae plane block)
Group ESP: Before induction of anaesthesia, the patient is placed on the operating table and placed in a forward tilted position. Asepsis and antisepsis conditions are provided. The linear USG probe is moved approximately 2-3 cm lateral to the spinous process T5 - T6 level on the side to be operated. The trapezius, rhomboid major and erector spinae muscles will be identified to find the correct probe position. A 22 gauge , 50 mm or 22 gauge 80 mm single shot nerve blocks needle will be inserted through the skin in a cranio-caudal direction. With the needle resting on the transverse process, the plane between the erector spinae muscle and the transverse process will be verified by hydrodissection with 5 ml saline solution. Then 20 ml of 0.25% bupivacaine will be injected. The ESP block will be considered successful if the local anaesthetic spreads linearly up to the T8 - T9 level. The patient will then be placed in the supine position and general anaesthesia will be administered.
Procedure: Erector spinae plane block
Before induction of anaesthesia, the patient is placed on the operating table and placed in a forward tilted position. Asepsis and antisepsis conditions are provided. The linear USG probe is moved approximately 2-3 cm lateral to the spinous process T5 - T6 level on the side to be operated. The trapezius, rhomboid major and erector spinae muscles will be identified to find the correct probe position. A 22 gauge 50 mm or 22 gauge 80 mm single shot nerve blocks needle will be inserted through the skin in a cranio-caudal direction. With the needle resting on the transverse process, the plane between the erector spinae muscle and the transverse process will be verified by hydrodissection with 5 ml saline solution. Then 20 ml of 0.25% bupivacaine will be injected. The ESP block will be considered successful if the local anaesthetic spreads linearly up to the T8 - T9 level. The patient will then be placed in the supine position and general anaesthesia will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: At the minute of admission to the postoperative care unit (PACU), in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
At the minute of admission to the postoperative care unit (PACU), in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inspiratory spirometry test
Time Frame: At the minute of admission to the postoperative care unit (PACU),in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery
The inspiratory spirometry test will be performed and the inspiratory flow rate calculated according to the number of rising balls will be recorded (1 ball = 600 ml, 2 balls = 900 ml, 3 balls = 1200 ml).
At the minute of admission to the postoperative care unit (PACU),in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery
Postoperative nausea and/or vomiting (PONV)
Time Frame: At the minute of admission to the postoperative care unit (PACU), in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery
Questioning about the presence/absence of nausea and/or vomiting in the postoperative period
At the minute of admission to the postoperative care unit (PACU), in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery
Amount of fentanyl used intraoperatively
Time Frame: during surgery
Amount of fentanyl used intraoperatively (µg)
during surgery
Amount of tramadol used postoperatively
Time Frame: during the postoperative 24 hour
Amount of tramadol used postoperatively (milligrams)
during the postoperative 24 hour
Surgery duration
Time Frame: at the end of surgery
Time in hours from the start of the surgical incision until the last surgical suture is placed
at the end of surgery
Anesthesia duration
Time Frame: as soon as the patient is extubated
time in hours from induction of anaesthesia to extubation
as soon as the patient is extubated
Length of stay in intensive care
Time Frame: It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first
Length of stay in intensive care unit in days
It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first
Length of hospital stay
Time Frame: It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first
days of hospitalisation after the operation
It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first

Collaborators and Investigators

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

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Investigators

  • Principal Investigator: Fatma Acil, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research 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)

October 3, 2023

Primary Completion (Estimated)

December 27, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 10.21.2022/216

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

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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