NCT07782073

Brief Summary

The overall goal of this work is to find the preferred continues catheter- based thoracic block for patients who undergoing major ROBOTIC assisted thoracic surgery (Lobectomy, multiple segmental resection and thoracotomy). Specifically, this project aims to complete the following:

  1. 1.To compare analgesic efficiency of continuous TPVB vs ESP block in patients undergoing major robotic thoracoscopic operation
  2. 2.To assess failure rate, time to catheter placement and patient satisfaction of each block group
  3. 3.To compare complication rate of each block

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jul 2026Jul 2028

Study Start

First participant enrolled

July 1, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

July 28, 2026

Last Update Submit

August 19, 2026

Conditions

Keywords

Paravertebral blockErector spinal blockcontinues block catheter basedRobotic surgeryThoracoscopic surgeryRegional anesthesia

Outcome Measures

Primary Outcomes (2)

  • Post operative opioid consumption

    measured by MME (morphine equivalent)

    From completion of surgery through hospital discharge, assessed up to 24 hours postoperatively

  • post operative pain

    measured by Visual Analog Scale (VAS); measured from 0 to 5, when 5- is maximal pain and 0 - no pain at all.

    Every 2 hours starting from PACU admission until hospital discharge, assessed up to 96 hours postoperatively.

Secondary Outcomes (1)

  • Patient satisfaction

    immediately before discharge from the hospital

Study Arms (2)

group A - TPVB

ACTIVE COMPARATOR

continues paravertebral block

Procedure: Paravertebral Nerve Block

group B - ESP

ACTIVE COMPARATOR

continues erector spinal block

Procedure: ESP block group

Interventions

Thoracic paravertebral block (TPVB) is the technique of injecting local anesthetic adjacent to the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramina. This results in ipsilateral somatic and sympathetic nerve blockade in multiple contiguous thoracic dermatomes above and below the site of injection It is effective in treating acute and chronic pain of unilateral origin from the chest and abdomen. Bilateral use of TPVB has also been described. Our understanding of the safety and efficacy of TPVB has improved significantly in the last two decades, prompting its use in children and neonates and for surgical anesthesia The TPVB is used to provide anesthesia and analgesia for breast surgery, surgery that requires coverage of the axilla (eg, creation of dialysis access, axillary lymph node dissection), or for thoraco-abdominal surgery as an alternative to thoracic epidural. The selected level for the block should be as close to the loca

group A - TPVB

we started performing ESP block for postoperative pain control in thoracic and abdominal surgery, with very satisfactory results so far. The block appears to be sufficient for postoperative pain control and the complications are yet to be seen. The results of our previous study show that ESP block is superior to pectoralis and serratus blocks-also used in thoracic surgery-in regard for a larger area of analgesia, easier injection, and longer duration. Also, it offers better safety profile than neuraxial analgesia or the thoracic paravertebral block The current literature suggests that ESP block is an excellent adjuvant to multi-modal analgesia not just for thoracic, but for abdominal surgery as well. It is an ultrasound guided interfacial block, achieved by injecting the local anesthetic solution between the transverse process and the erector spinae muscles (iliocostalis, longissimus, and spinalis). It can be performed either as a single shot or as a continuous catheter techniqu

group B - ESP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • All patients undergo major robotic thoracic surgery

You may not qualify if:

  • Patients who refuse to participate in the study.
  • Patients who are unable to give an informed consent.
  • Patients with local inflammation at the puncture site
  • Patients with known allergy to local anesthetisc
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka Medical center

Beersheba, Israel

Location

Related Publications (1)

  • 1. H,Nagano, T. Suda, Advantages and disadvantages of robotic and uniportal video-assisted thoracoscopic surgery, Video-assist Thorac Surg 2021;6:14 | http://dx.doi.org/ 2. Veronesi G. Robotic lobectomy and segmentectomy for lung cancer: results and operating technique. J Thorac Dis 2015;7 3. Novellis P, Bottoni E, Vonlaz E, et al. Robotic surgery, video-assisted thoracic surgery, and open surgery for early stage lung cancer: comparison of costs and outcomes at a single institute. J Thorac Dis 2018;1 4. Louie BE, Farivar AS, Aye RW, et al. Early experience with robotic lung resection results in similar operative outcomes and mobidity with compared with matched video-assisted thoracoscopic surgery cases. Ann Thorac Surg 2012;93:1598-6 5. Karmakar M., Thoracic Paravertebral Block, Anesthesiology 2001; 95:771-80 6. S. Feray,J. Lubach,G. P. Joshi,F. Bonnet, M. Van de Velde, PROSPECT guidelines for video-assisted thoracoscopic surgery: a systematic review and procedure-specific postoperative pain management recommendations, Anaesthesia 2022, 77, 311-325 7. Krishna, S.N.; Chauhan, S.; Bhoi, D.; Kaushal, B.; Hasija, S.; Sangdup, T.; Bisoi, A.K. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J. Cardiothorac. Vasc. Anesth. 2019, 33, 368-375. 8. Kawagoe, I.; Hayashida, M.; Satoh, D.; Kochiyama, T.; Fukuda, M.; Kishii, J. Postoperative analgesia in patients undergoing robot-assisted thoracic surgery: A comparison between thoracic epidural analgesia and intercostal nerve block combined with intravenous patient-controlled analgesia. Ann. Palliat. Med. 2021, 10, 1985-1993 9. A. Pawa,, T. Wojcikiewicz,, A. Barron, ,K. El-Boghdadly,, Paravertebral Blocks: Anatomical, Practical, and Future Concepts, Current Anesthesiology Reports (2019) 9:263-270 10. A. Ardon, J. Lee, C. D. Franco, K. T. Riutort, R. A. Greengrass, Paravertebral block: anatomy and relevant safety issues, Korean J Anesthe

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: comparing two types of regional anesthesia blocks for specific type operation ( ROBOTIC )
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician, Anesthesia and acute pain service; Principal Investigator.

Study Record Dates

First Submitted

July 28, 2026

First Posted

August 24, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

August 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication will be shared in future publication

Locations