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PainNCT02911168

Comparison of US-Guided Paravertebral and Proximal Intercostal Nerve Blocks

A study testing Proximal Intercostal Block and Paravertebral Block in people with Pain, run by Brigham and Women's Hospital at 1 site in United States.

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 purpose of this study is to compare the proximal intercostal block to the more medial (classic) ultrasound-guided paravertebral block. The investigators hypothesize that the proximal intercostal block will allow for improved needle visualization, shorter block time, and improved safety profile compared to the… Read more about this study

Who is it for?
Ages 18 to 85 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Proximal Intercostal Block and Paravertebral Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
9 Sep 2016to 7 Jan 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 85 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Females age 18-85 years old
  • ASA 1-3
  • Patient scheduled for unilateral or bilateral mastectomy with or without reconstruction

Who cannot join

  • Coagulopathy
  • Patient refusal
  • Allergy to local anesthetics

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: A Prospective, Randomized Comparison Between the Ultrasound Guided Paravertebral Block and the Ultrasound Guided Proximal Intercostal Nerve Block

The purpose of this study is to compare the proximal intercostal block to the more medial (classic) ultrasound-guided paravertebral block. The investigators hypothesize that the proximal intercostal block will allow for improved needle visualization, shorter block time, and improved safety profile compared to the classic paravertebral bock.

Read the detailed description

Although previous studies have made advances towards applying ultrasound guidance to the performance of paravertebral blocks (PVB), a technique combining both safety and technical ease remains elusive. The ideal technique (1) permits continuous visualization of the entire needle shaft and tip, (2) avoids aiming the needle tip and injectate directly toward the neuraxis or lung, and (3) is easy to perform. Visualization of all structures by ultrasound is essential to minimize the risk of vascular puncture, nerve root or spinal cord injury, and pneumothorax. Failure to consistently and quickly identify the transverse process and pleura, as occurs when using older techniques, results in several needle redirections, causing pain and discomfort to patients, and increases the potential risk of pneumothorax. The technical difficulty of applying previously-described US-guided techniques takes an inordinate amount of time and is clinically less practical within a busy surgical practice.

In the current study, the investigators describe a novel, modified approach to real-time ultrasound-guided single shot paravertebral blockade, the proximal intercostal block (PICB), which utilizes a sagittal paramedian US probe placement to identify the intercostal space and PVS. In this method, instead of placing the probe at a fixed traditional distance of 2.5 cm from the spinous processes, the probe is moved laterally to obtain a comprehensive image, with a clear view of the ribs, internal intercostal membrane, and the parietal pleura.

The investigators propose that moving the probe laterally towards the proximal intercostal space allows clearer simultaneous visualization of both pleura and needle as it advances towards the PVS, while achieving comparable injectate spread and, ultimately, similar or better clinical results. Such improved visualization will reduce the number of needle passes, increase confidence in the user, decrease block placement time, and improve overall block success. This technique combines the advantages of more lateral approaches (better visualization of structures, in particular the pleura) with the advantage of the more medial approaches (in-plane, closer, and not directed at the neuraxis).

Conditions
Pain
Being tested
Proximal Intercostal Block, Paravertebral Block
Keywords
NERVE BLOCK, ANESTHESIA RECOVERY PERIOD, PAIN MANAGEMENT
Medical subject headings
Pain, Agnosia

What participants receive

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

  • Proximal Intercostal BlockProcedure or surgery

    Also called PICB

    After identifying the correct intercostal space, the ultrasound probe will be moved medially to identify the transverse processes, then again laterally from the transverse processes to rest over the ribs so as to obtain the best view of ribs and pleura. A 10cm, 21G needle will be inserted in-plane at the caudal border of the probe. An attempt will be made to keep the needle tip and the target injection position (just under the internal intercostal membrane (IIM)) in view. Correct needle tip placement will be demonstrated by depression of the pleura/endothoracic fascia upon local anesthetic injection and by lack of retrograde spread of LA over the muscles or the ribs. The LA will be injected in 4 cc aliquots after negative aspiration of air, CSF and blood.

  • Paravertebral BlockProcedure or surgery

    Also called PVB

    After identifying the correct intercostal space, the ultrasound probe will be placed between the adjacent transverse processes in a longitudinal/parasagittal plane measuring 2.5cm from the midline. The best possible view of the transverse processes, the superior costotransverse ligament and pleura will be obtained. An attempt will be made to keep the needle tip and the target injection position (immediately beneath the costotransverse ligament) in view. Correct placement of the needle tip will be demonstrated by depression of the pleura upon injection of local anesthetic and by lack of retrograde spread of LA over the muscles or transverse processes. The LA will be injected in 4 cc aliquots after confirming negative aspiration of air, CSF and blood.

Study groups in NCT02911168
Study groupRoleWhat they receive
Proximal Intercostal BlockActive comparatorSee Intervention Section
Receives: Procedure: Proximal Intercostal Block
Paravertebral BlockActive comparatorSee Intervention Section
Receives: Procedure: Paravertebral Block

What is being measured

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

  1. Ultrasound Image Quality Score

    The following will be assessed for each image and video, and saved during each block performed:

    1. Best possible image of block anatomy (including the pleura, transverse process/rib, costotransverse ligament/internal intercostal membrane, as appropriate) as well as needle location.
    2. Video of the space during injection, reflecting the injectate spread. The images will be rated by a separate regional anesthesiologist not involved in study, but proficient with both types of blocks and ultrasound imaging.
    3. The following score 3 point scale will be used to rate visibility: 0=not visible, 1=hardly visible, 2=well visible, 3=very well visible. Maximum score possible=18 including both pieces of media.

    Measured: Evaluated at time of block

Secondary outcomes (10)
  1. Block Performance Time

    Defined as the sum of imaging and needling times

    Measured: Evaluated at time of block

  2. Imaging Time

    Defined as the time interval between contact of the ultrasound probe with the patient, and the acquisition of a satisfactory image (which will be saved and analyzed later by a regional anesthesiologist blinded to the particular aims of the study).

    Measured: Established during block performance

  3. Needling Time

    Defined as the time interval between the start of the skin wheal and the end of local anesthetic injection through the block needle.

    Measured: Established during block performance

  4. Number of Needle Passes

    Initial needle insertion will be counted as "first pass". Any subsequent needle advancement, preceded by a retraction of more than 2 cm, will be counted as an additional pass.

    Measured: Established during block performance

  5. Distance of Injection Sites from Midline

    Measured and recorded (one of our clinical aims)

    Measured: Established during block performance

  6. Presence of Perioperative Block-Related Complications

    The presence of the following complications will be recorded:

    1. Horner's syndrome
    2. Pneumothorax
    3. Local anesthetic systemic toxicity (LAST)
    4. Pain on injection
    5. Evidence of contralateral block (for unilateral procedures)

    Measured: Within 24 hours of block placement

  7. Effectiveness of the Block

    Patients will be asked to provide a verbal rating score of pain (0-10) at two time points: one hour following extubation, and 24h following block placement. At the 1 hour following extubation time point, we will be checking the coverage of the block in terms of dermatomal spread (see below).

    Measured: One hour following extubation, and at 24 hours following block placement

  8. Dermatomal spread

    Number of dermatomal block levels, determined by loss of sensation to cold (ice) or to loss of pinprick sensation in the PACU one hour after extubation.

    Measured: One hour following extubation

  9. Opioid requirement

    Opioid requirement, including intraoperative, PACU, and during the entire hospital admission, normalized to morphine equivalents.

    Measured: Evaluated at 1 hour after extubation, and then at 24 hours following the block

  10. Prolonged postoperative pain

    Postoperative contact via secure e-mail at will assess for the incidence of chronic pain.

    Measured: 6 and 12 months 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 posted22 Sep 2016 (estimated)
  2. Study start9 Sep 2016
  3. Primary completion13 Jul 2017
  4. Study completion7 Jan 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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02911168
Sponsor's protocol ID
2016P000174/MGH
Status last verified
Nov 2025
First submitted
12 Aug 2016
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14.

    PubMed 20947592
  • Fleischmann K. Ultrasound-guided thoracic parvertebral blocks: anatomy , approaches and techniques. Asra. 2012.

  • Luyet C, Herrmann G, Ross S, Vogt A, Greif R, Moriggl B, Eichenberger U. Ultrasound-guided thoracic paravertebral puncture and placement of catheters in human cadavers: where do catheters go? Br J Anaesth. 2011 Feb;106(2):246-54. doi: 10.1093/bja/aeq309. Epub 2010 Nov 25.

    PubMed 21112880
  • Eason MJ, Wyatt R. Paravertebral thoracic block-a reappraisal. Anaesthesia. 1979 Jul-Aug;34(7):638-42. doi: 10.1111/j.1365-2044.1979.tb06363.x.

    PubMed 517716
  • Naja Z, Lonnqvist PA. Somatic paravertebral nerve blockade. Incidence of failed block and complications. Anaesthesia. 2001 Dec;56(12):1184-8. doi: 10.1046/j.1365-2044.2001.02084-2.x.

    PubMed 11736777
  • Lonnqvist PA, MacKenzie J, Soni AK, Conacher ID. Paravertebral blockade. Failure rate and complications. Anaesthesia. 1995 Sep;50(9):813-5. doi: 10.1111/j.1365-2044.1995.tb06148.x.

    PubMed 7573876
  • Naja MZ, Ziade MF, Lonnqvist PA. Nerve-stimulator guided paravertebral blockade vs. general anaesthesia for breast surgery: a prospective randomized trial. Eur J Anaesthesiol. 2003 Nov;20(11):897-903. doi: 10.1017/s0265021503001443.

    PubMed 14649342
  • Mehta Y, Arora D, Sharma KK, Mishra Y, Wasir H, Trehan N. Comparison of continuous thoracic epidural and paravertebral block for postoperative analgesia after robotic-assisted coronary artery bypass surgery. Ann Card Anaesth. 2008 Jul-Dec;11(2):91-6. doi: 10.4103/0971-9784.41576.

    PubMed 18603748
  • Richardson J, Cheema SP, Hawkins J, Sabanathan S. Thoracic paravertebral space location. A new method using pressure measurement. Anaesthesia. 1996 Feb;51(2):137-9. doi: 10.1111/j.1365-2044.1996.tb07700.x.

    PubMed 8779368
  • Pusch F, Wildling E, Klimscha W, Weinstabl C. Sonographic measurement of needle insertion depth in paravertebral blocks in women. Br J Anaesth. 2000 Dec;85(6):841-3. doi: 10.1093/bja/85.6.841.

    PubMed 11732516
  • O Riain SC, Donnell BO, Cuffe T, Harmon DC, Fraher JP, Shorten G. Thoracic paravertebral block using real-time ultrasound guidance. Anesth Analg. 2010 Jan 1;110(1):248-51. doi: 10.1213/ANE.0b013e3181c35906. Epub 2009 Nov 21.

    PubMed 19933536
  • Ben-Ari A, Moreno M, Chelly JE, Bigeleisen PE. Ultrasound-guided paravertebral block using an intercostal approach. Anesth Analg. 2009 Nov;109(5):1691-4. doi: 10.1213/ANE.0b013e3181b72d50.

    PubMed 19843811
  • Burns DA, Ben-David B, Chelly JE, Greensmith JE. Intercostally placed paravertebral catheterization: an alternative approach to continuous paravertebral blockade. Anesth Analg. 2008 Jul;107(1):339-41. doi: 10.1213/ane.0b013e318174df1d.

    PubMed 18635506
  • Renes SH, Bruhn J, Gielen MJ, Scheffer GJ, van Geffen GJ. In-plane ultrasound-guided thoracic paravertebral block: a preliminary report of 36 cases with radiologic confirmation of catheter position. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):212-6. doi: 10.1097/aap.0b013e3181c75a8b.

    PubMed 20301827
  • Marhofer P, Kettner SC, Hajbok L, Dubsky P, Fleischmann E. Lateral ultrasound-guided paravertebral blockade: an anatomical-based description of a new technique. Br J Anaesth. 2010 Oct;105(4):526-32. doi: 10.1093/bja/aeq206. Epub 2010 Aug 3.

    PubMed 20685684

Questions about this trial

What is this clinical trial studying?

A study testing Proximal Intercostal Block and Paravertebral Block in people with Pain, run by Brigham and Women's Hospital at 1 site in United States.

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 3 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 25 Nov 2025. 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 United States. 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?

Ultrasound Image Quality Score (time frame: Evaluated at time of block). 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 NCT02911168, which also lists 18 linked publications.

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 25 Nov 2025.

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