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Opioid UseNCT05321576

Opioid-free Anesthesia With ESPB in VATS Operation

A study testing Erector spinae plane block (ESPB) technique without opioid use in people with Opioid Use, run by Marmara 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

Patients with an ASA score of 3 and below, who will undergo lobectomy with video-assisted thoracic surgery (VATS) method, and who gave informed consent will be included in this study. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Opioid Use
What is being tested?
Erector spinae plane block (ESPB) technique without opioid use
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Mar 2022to 1 May 2022
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • lobectomy with video-assisted thoracic surgery (VATS) method
  • ASA score of 3 and below
  • willing to be included

Who cannot join

  • chronic pain
  • current opioid use
  • local anesthetic allergy
  • spinal deformity or mental or psychiatric problems that prevent cooperation
  • anticoagulant use
  • infection at the injection site

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Marmara University

    Istanbul, Maltepe, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of ESPB With Opioid-free Anesthesia and Standardopioid Anesthesia in Patients Who Underwent Lobectomy With VATS Method: a Randomized Controlled Study.

Patients with an ASA score of 3 and below, who will undergo lobectomy with video-assisted thoracic surgery (VATS) method, and who gave informed consent will be included in this study. Patients with contraindications for the application of either of the two methods, with known chronic pain, opioid use, local anesthetic allergy, spinal deformity or mental or psychiatric problems that prevent cooperation, those taking anticoagulants, and those with infection at the injection site will not be included in the study. In addition, patients in the ESPB group who required intraoperative opioids, patients who failed ESPB, and patients who underwent open surgery in both groups will not be included in the analysis. Patients who agree to participate in the study will be randomly assigned to one of the study's opioid-free anesthesia and ESPB (erector spina plan block) (Group 1) or standard opioid (Group 2, control) anesthesia groups. Randomization will be at the ratio of 1:1 and will be done by the closed envelope method. Beforehand, a piece of paper with the name of one of the two groups will be placed inside the envelopes and the envelopes will be closed and mixed. A closed envelope will be drawn at random before the procedure for each patient, and procedures will be carried out according to the group specified on the paper.

Read the detailed description

Group 1 (opioid-free ESPB) Before induction of anesthesia, patients in this group will undergo ultrasound guidance in a sitting position on the operating table, and an erector spina plan block will be performed with bupivacaine and lidocaine, by entering unilaterally (to the side to be operated) 3 cm lateral to the T5 spinous process. Under standard monitoring (ECG, non-invasive blood pressure, and finger oxygen saturation), anesthesia induction will be performed with propofol (2 mg/kg), ketamine 2 mg/kg, and rocuronium 0.6 mg/kg. Bispectral index (BIS) and analgesia nociception index (ANI) monitoring will be started immediately after intubation. Patients will not take any opioids throughout the surgery and will be infused with dexmedetomidine instead. Dexmedetomidine infusion will be started at a dose of 0.4 microgram/kg/hour, BIS < 50 and the dose of dexmedetomidine will be adjusted so that ANI > 50. Patients for whom dexmedetomidine could not be sufficiently effective and opioid use became mandatory will not be included in the analysis. Before postoperative awakening, patients were given 1 g i.v. paracetamol will be given.

Group 2 (standard anesthesia with opioid) Under standard monitoring (ECG, non-invasive blood pressure, and finger oxygen saturation), anesthesia induction will be performed with propofol (2 mg/kg), remifentanil 1 microgram/kg, and rocuronium 0.6 mg/kg. Bispectral index (BIS) and analgesia nociception index (ANI) monitoring will be started immediately after intubation. Patients will receive an infusion of remifentanil throughout the surgery. Remifentanil infusion will be started at a dose of 0.5 microgram/kg/hour, and the dose of remifentanil will be adjusted so that BIS < 50 and ANI > 50. Before postoperative awakening, patients were given 1 g i.v. paracetamol will be given.

Perioperative clinical and demographic data of each patient will be collected: age, gender, diagnosis, operation, ASA status, duration of surgery, duration of anesthesia. Intraoperatively, heart rate, blood pressure, ANI and BIS measurements will be made and recorded in all patients at 15-minute intervals. In addition, the total intraoperative opioid dose (Group 2) and dexmedetomidine (Group 1) dose will be recorded.

Post-awakening pain will be assessed and recorded using a visual analog scale (VAS), then patient-controlled analgesia (PCA) will be initiated, with all patients locked in 15 minutes and given 4 mg of morphine at each application by the patient. Pain assessment will be done with VAS at 6, 12, 24 and 48 hours postoperatively. In the postoperative period, the amount of morphine administered by PCA (in the first and second 24 hours) and the required additional analgesics (tramadol, paracetamol, etc.) will be recorded. Groups will be compared for primary outcome measure and secondary outcome measure.

Although neuropathic pain after VATS is less than the thoracotomy approach, it can still pose a significant postoperative problem. Pain management after VATS is especially important to prevent respiratory complications. However, intraoperative or postoperative excess morphine consumption will also negatively affect postoperative recovery after thoracic surgery. It has been shown that opioid-free anesthesia can reduce the need for morphine and reduce related complications.

In the ultrasound-guided erector spina plan block technique, which is a regional anesthesia technique that has been defined recently, local anesthetic is injected into the erector spina muscle and facial plane and spreads in the caudal and cranial directions. This technique has been successfully used as a postoperative analgesia or intraoperative regional anesthesia technique in areas such as thoracic surgery and trauma, breast surgery, abdominal surgery, and extremity surgery. Erector spina plane block or other block methods have been mostly used for postoperative analgesia after VATS, and they have been shown to provide effective postoperative analgesia and reduce morphine consumption. However, data on the use of ESPB or other block techniques for anesthesia during VATS are limited. Opioid-free anesthesia with the help of ESPB may help recovery by reducing total and postoperative morphine consumption.

The aim of this study is to compare opioid-free anesthesia with ultrasound-guided ESPB in patients who underwent lobectomy with VATS, with standard opioid-containing anesthesia in terms of postoperative morphine requirement, as well as intraoperative variables, postoperative pain management and postoperative recovery, and complications.

Conditions
Opioid Use
Being tested
Erector spinae plane block (ESPB) technique without opioid use

What participants receive

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

  • Erector spinae plane block (ESPB) technique without opioid useProcedure or surgery

    Also called Standard opioid anesthesia

    Local anesthetic injection to the erector spinae muscle plane at T5 level on the operation side.

Study groups in NCT05321576
Study groupRoleWhat they receive
erector spinae plane block groupActive comparatorBefore this process, it will be produced from the bupivacaine plan, which will be made by entering unilaterally 3 cm lateral in the ultrasound to be made from a work section that will be made before the shipment and by lidocaine.
Receives: Procedure: Erector spinae plane block (ESPB) technique without opioid use
control groupActive comparatorgive opiod in this group of patients
Receives: Procedure: Erector spinae plane block (ESPB) technique without opioid use

What is being measured

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

  1. Opioid consumption

    measurement of postoperatif opioid requirement and consumption

    Measured: the first 48 hours after surgery

Timeline

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

  1. First posted11 Apr 2022
  2. Study start10 Mar 2022
  3. Primary completion10 Apr 2022
  4. Study completion1 May 2022

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
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05321576
Sponsor's protocol ID
09.2022.100
Status last verified
Mar 2022
First submitted
3 Mar 2022
Last updated
10 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Erector spinae plane block (ESPB) technique without opioid use in people with Opioid Use, run by Marmara 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 3 inclusion and 6 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 10 May 2022. 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?

Opioid consumption (time frame: the first 48 hours after surgery). 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 10 May 2022.

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