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Postoperative PainNCT05080985

Paravertebral Block Versus Erector Spinae Plane Block for Analgesia in Modified Radical Mastectomy

A study testing TPVB, ESPB and Bupivacain in people with Postoperative Pain, run by Istanbul 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

The study is planned to be a single-center randomized, prospective double-blind study and includes patients who planned to be done unilateral MRM (modified radical mastectomy) operation in Istanbul University Istanbul Faculty of Medicine. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Postoperative Pain
What is being tested?
TPVB, ESPB and Bupivacain
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Nov 2018to 1 Mar 2020
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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • unilateral MRM
  • ages 18-75 years
  • American Society of Anesthesiologists (ASA) classification I-III

Who cannot join

  • presence of contraindications for using regional anesthesia (not having patient approval, presence of bleeding-clotting disorders, infection at the injection site, local anesthetic allergy)
  • chronic analgesic use
  • diabetes mellitus
  • body mass index of (BMI) > 35 kg/m2.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University, Istanbul Faculty of Medicine

    Istanbul, 34093

Other trials in Turkey (Türkiye)

About this study

Official title: Paravertebral Block Versus Erector Spinae Plane Block for Analgesia and Opioid Consumption in Modified Radical Mastectomy; Randomized, Prospective, Double Blind

The study is planned to be a single-center randomized, prospective double-blind study and includes patients who planned to be done unilateral MRM (modified radical mastectomy) operation in Istanbul University Istanbul Faculty of Medicine. The objective of this study is to compare postoperative analgesic efficacies of TPVB (thoracic paravertebral block) and ESPB (erector spinae plane block) performed under ultrasound (USG) guidance after MRM. Primary outcome of this study is postoperative 24-hour morphine consumption whereas secondary outcomes were planned as the comparison of changes in hemodynamic parameters and numeric rating pain score (NRS).

Read the detailed description

A total of 86 patients were randomized into TPVB (Group P) and ESPB (Group E) by using closed envelopes.

All patients in the operating room has same anesthetic management under standard monitoring modalities. Prior to regional technique, mild sedation was achieved with midazolam (1-2 mg) and fentanyl (50 mcg). Both blocks were performed under ultrasonography guidance from the level of T4 vertebra with a linear probe (5MHz; GE Healthcare, Wauwatosa, Wis, USA) using longitudinally out-of-plane technique by an anesthesiologist. A 22-gauge, 50 mm insulated stimulating needle was used.By using reference points of C7 and T7, spinous processes of thoracic vertebras were marked. 10% povidone iodine was used for skin antisepsis. USG probe was longitudinally placed at the level of T4. Staff anesthesiologist had to visualize of adjacent muscles, transverse process (TP) and pleura.

For ESPB; confirmation of the needle position was achieved with spread of 2 ml saline between the deep fascia of the erector spinae muscle and the TP. After negative aspiration 20 ml 0.375% bupivacaine was injected with appropriate distribution of LA.

For TPVB; the needle was advanced passing over superior costotransverse ligament and target space was confirmed by the downward displacement of pleura after the administration of 2 ml 0.9% NaCl. After negative aspiration, 20 ml 0.375 % bupivacaine was injected with appropriate distribution of local anesthetics.

Vascular puncture, haematoma, neuraxial injury and pneumothorax were defined as block complications and should be noted.

30 minutes after the block achieved, pinprick test was performed on both mid-axillary and midclavicular lines from T1 to T12 (0 there is sensation, 1 decreased sensation, 2 there is no sensation).

Anesthesia induction was unique for all patients with 0.03 mg kg-1 midazolam, 0.5 mcg kg-1 fentanyl, 2 mg kg-1 propofol and 0.6 mg kg-1 rocuronium. Maintenance was achieved with sevoflurane of 1 minimum alveolar concentration in a mixture of 40% O2 and 60% N2O. As a component of multimodal analgesia, paracetamol (1 gr) was applied to all patients before skin incision.

Hemodynamic data were recorded throughout surgery. An increase more than 20% from baseline in mean arterial pressure (MAP) was defined as inadequate analgesia and was treated with bolus fentanyl (50 mcg). Hypotension was described with a decrease more than 20% in MAP and treated with ephedrine bolus. Bradycardia was determined with a heart rate (HR) less than 50 beats min-1 and treated with atropine. At the end of surgery, the patients were extubated in operating room.

Postoperative analgesia was achieved with IV morphine via Patient Controlled Analgesia (PCA) for 24 hours (0.01 mg kg-1 h-1 basal infusion, 1 mg bolus, 20 minutes lock-out time).

Postoperative follow-up included hemodynamic variables as well as pain scores and morphine consumption. Adequate analgesia at rest (static) and at moving of the arm interpreted as 45-90 degree abduction (dynamic) was investigated with Numeric Rating Scale (NRS) at 30th minute and 1st, 4th, 6th, 12th, 24th hours postoperatively. When NRS was 4 and higher, tramadol should be administered as rescue analgesic. In case of insufficient pain control at 30th minute, dermatomal analgesia should be assessed for both mid-axillary and midclavicular lines from T1 to T8 by pinprick test (0 there is sensation, 1 decreased sensation, 2 there is no sensation). Morphine consumption was evaluated at same study times.

Complications were determined as sedation assessed by Ramsey scale, postoperative nausea- vomiting (PONV) assessed with the four-point categorical scale (0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once). Severe vomiting should be treated in a multimodal way and excluded from the study (category 2,3).

Staff anesthesiologist responsible for operative course did not contribute in analgesia assessment, nor in other postoperative follow-up. Other investigators who were blinded to operative management, collected postoperative data.

Being tested
TPVB, ESPB, Bupivacain
Keywords
Acute postoperative pain, Nerve block, Thoracic wall
Medical subject headings
Pain, Postoperative

What participants receive

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

  • TPVBProcedure or surgery

    20 ml 0.375 % bupivacaine was injected between superior costotransverse ligament and pleura.

  • ESPBProcedure or surgery

    20 ml 0.375 % bupivacaine was injected between deep fascia of the erector spinae muscle and transverse process.

  • BupivacainDrug

    20 ml 0.375 % bupivacaine was injected

Study groups in NCT05080985
Study groupRoleWhat they receive
Group P : TPVBExperimentalThoracic paravertebral block
Receives: Procedure: TPVB; Drug: Bupivacain
Group E : ESPBExperimentalErector spinae plane block
Receives: Procedure: ESPB; Drug: Bupivacain

What is being measured

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

  1. Morphine consumption

    amount of postoperative 24 hours morphine consumption

    Measured: postoperative 24 hours

Secondary outcomes (5)
  1. Static and dynamic pain score assessed with Numeric Rating Scale (NRS).

    Pain scores will be noted postoperative at 0, 30 minutes and 1,4,6,12,24 hours. NRS=0 (minimum value, no pain). NRS=10 (maximum value, worst pain imaginable).

    Measured: postoperative 24 hours

  2. intraoperative heart rate

    starting from induction to extubation (beat/min)

    Measured: during surgery

  3. intraoperative mean arterial pressure

    starting from induction to extubation (mmHg)

    Measured: during surgery

  4. nause and vomit

    Assessed with Postoperative Nause and Vomit (PONV) Scale. (0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once)

    Measured: postoperative 24 hours

  5. number of blocked dermatome

    pinprick test in mid-axillar and mid-clavicular line

    Measured: 30 minutes after block

Timeline

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

  1. First posted18 Oct 2021
  2. Study start20 Nov 2018
  3. Primary completion1 Mar 2020
  4. Study completion1 Mar 2020

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05080985
Sponsor's protocol ID
2018-1608
Status last verified
Oct 2021
First submitted
15 Sep 2021
Last updated
18 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

    PubMed 27501016

Questions about this trial

What is this clinical trial studying?

A study testing TPVB, ESPB and Bupivacain in people with Postoperative Pain, run by Istanbul 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 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 18 Oct 2021. 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?

Morphine consumption (time frame: postoperative 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05080985, which also lists 1 linked publication.

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 18 Oct 2021.

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