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Thoracic DiseasesNCT04309630

Comparison of Continuous Erector Spina Plane Block With Intercostal Block in Acute and Chronic Pain Control After Thoracotomy

A study testing intercostal block and erector spina plane block in people with Thoracic Diseases, run by Ankara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Thoracotomy is associated with severe postoperative pain due to surgical incision, rib retraction or resection, and intercostal nerve damage. Pain management after thoracic surgery is extremely important for various reasons, including respiratory mechanics, decreased atelectasis, early mobilization, decreased opioid… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Thoracic Diseases
What is being tested?
intercostal block and erector spina plane block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2020to 1 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA I-II
  • Thoracotomy patients

Who cannot join

  • Body mass index over 35
  • A history of allergy to drugs to be used in the study
  • Chronic pain reliever use
  • Patients who refuse to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Cigdem Yildirim Guclu

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Continuous Erector Spina Plan Block With Intercostal Block in Acute and Chronic Pain Control After Thoracotomy

Thoracotomy is associated with severe postoperative pain due to surgical incision, rib retraction or resection, and intercostal nerve damage. Pain management after thoracic surgery is extremely important for various reasons, including respiratory mechanics, decreased atelectasis, early mobilization, decreased opioid consumption, decreased hospital stay, and patient satisfaction.

Thoracic epidural analgesia and thoracic paravertebral blocks, although it comes to mind in the first place for thoracic surgery, the difficulty / failure of the application technique and the use of side effects such as spinal cord injury, pneumothorax and hypotension.

Read more

Alternative regional methods have come to the fore in recent years. Erector spina plan block (ESPB) is a recently defined interfacial plan block used for the treatment of thoracic neuropathic pain, trauma and acute pain after surgery.

Local anesthetic injection for ESPB can be applied both to the surface and deep into the erector spina muscle. When local anesthetic is applied deep into the erectral spina muscle, it has been demonstrated by the cadaver findings that the thoracic spinal nerves reach both the dorsal and ventral ramus with the spread of the paravertebral and intercostal areas. The thoracolumbar extension of the erector spina muscle allows wide cranio-caudal spread of injections in this plane and analgesia involving multiple dermatomes. This multisegmental analgesia allows ESPB to be used in pain management after thoracic or abdominal surgery.

Accompanied by ultrasound, ESPB is simple and reliable. With the easy recognition of sonoanatomy, the risk of damage to the surrounding tissues is negligible . If necessary, a permanent catheter can be placed that can be used to prolong analgesia time and can be used for both intraoperative and postoperative analgesia with catheter-mediated ESPB.

Read the detailed description

After the approval of the ethics committee, patients with ASA I-II, elective thoracotomy plan will be informed that they will be included in the study before the operation and informed consent will be obtained. Routine preoperative anesthesia examinations of the patients will be performed. When patients come to the operating table, after routine monitoring of ECG, non-invasive blood pressure, pulse oximeter, BIS and TOF, sedation will be applied to patients.

After preoxygenation is performed with oxygen flow of 4 l / min, anesthesia induction will be applied to patients with propofol 3mg / kg and rocuronium 0.6mg / kg, and the patient will be intubated after sufficient muscle relaxation is achieved. Maintenance of anesthesia will be provided with BIS 40-60 with desflurane and 50% air + 50% O2. During the operation period, patients will receive 50mcg of fentanyl per hour for intraoperative analgesia and 10mg rocuronium to maintain muscle relaxation. At the end of the surgery, patients will be administered IV 1gr paracetamol and 4mg ondansetron to reduce the risk of vomiting postoperative nausea.

At the end of the surgery, thoracic vertebral spinous processes will be displayed by placing the linear ultrasound probe in the middle line at the level of T5 vertebra under the aseptic conditions while in the lateral decubitus position. Then, the transducer process of the subcutaneous adipose tissue, m.trapezius, m.rhomboideus major, m.erector spina and T5 vertebra will be displayed by shifting the probe 2-3cm laterally. After the needle placement is confirmed by hydrodissection with 3ml of 0.9% NaCl under the erector spina muscle, after 20ml 0.5% bupivacaine injection, the catheter will be placed in the 2-3cm intercostal area and the infusion of 2-4ml / hour 0.5% bupivacaine, daily total dose 400mg will not be exceeded. In the second group of patients, catheter will be placed in the intercostal area by the surgical team at the end of the surgery and 2-4ml / hour 0.5% bupivacaine infusion will be adjusted so that the total daily dose does not exceed 400mg.

After the anesthetic agent is terminated, when the TOF is 4, the effect of the muscle relaxant will be reversed by applying neostigmine and atropine to the patients. In order to provide analgesia to the patients in the postoperative period, the IV patient controlled analgesia device will be prepared as bolus with a 10-minute lock time, with the total dose of fentanyl not exceeding 1mcg / kg per hour, and will be started by explaining to the patients in the post-surgery department. If VAS> 4 and PCA bolus is insufficient, patients will receive paracetamol 1gr IV infusion.

Surgical procedures, incision length, operation time, total muscle relaxant and fentanyl doses used in the intraoperative period, the amount of fluid given to the patients, the amount of urine of the patients, the amount of bleeding during the operation, and the patient's blood pressure, heart rate and additional drug use will be recorded in the operation room.

Visual analogue scale (VAS) scores, satisfaction, nausea, vomiting, antiemetic use, itching complaints, mean artery at 30 minutes, 6,12,24,48,72 hours and postoperative time of chest withdrawal time. pressure, heart rate and saturation are monitored, the quality of the recovery will be evaluated with ALDRETE scoring and additional analgesic needs will be questioned. Patient controlled analgesia device will be requested at 30 minutes, 6, 12, 24 and 48 hours, and the number of bolus requested by the patient, the number of bolus delivered to the patient and the amount of drug will be recorded.

In the postoperative 3 and 6 months, when patients come for control, it will be learned from the patient whether they have pain, and if there is any pain, whether any procedure is applied for this pain.

Being tested
intercostal block, erector spina plane block
Medical subject headings
Thoracic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intercostal blockProcedure or surgery

    pain control by intercostal block

  • erector spina plane blockProcedure or surgery

    pain control by erector spina plane block

Study groups in NCT04309630
Study groupRoleWhat they receive
intercostal blockActive comparatorpatients received intercostal block will be evaluated by visual analog score for pain assesment
Receives: Procedure: intercostal block
erector spina plane blockExperimentalpatients received erector spina plane block will be evaluated by visual analog score for pain assesment
Receives: Procedure: erector spina plane block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. analgesia

    postoperative analgesia assesment with visual analog score

    Measured: 48 hours

Secondary outcomes (2)
  1. analgesia

    postoperative analgesia assesment with visual analog score

    Measured: 3 months

  2. analgesia

    postoperative analgesia assesment with visual analog score

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2020
  2. Study start1 Mar 2020
  3. Primary completion1 Jul 2021
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04309630
Sponsor's protocol ID
12-92-20
Status last verified
Jan 2024
First submitted
12 Mar 2020
Last updated
31 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing intercostal block and erector spina plane block in people with Thoracic Diseases, run by Ankara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

analgesia (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.

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