NCT04929665

Brief Summary

Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. Generally, comparisons are made between ESPB and TPVB in studies and the analgesic effect is evaluated. However, no research could be found in the literature combining ESPB and TPVB. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of TPVB and ESPB, as in the multimodal analgesia method. This study seeks to evaluate the effect of TPVB, ESPB and combined TPVB-ESPB pain after VATS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

April 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2021

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

June 10, 2021

Last Update Submit

July 13, 2021

Conditions

Pain, PostoperativeThoracic Surgery, Video-AssistedThoracic Paravertebral BlockErector Spinae Plane Block

Keywords

Erector spinae block, Thoracic paravertebral block, VATS

Outcome Measures

Primary Outcomes (1)

  • Pain scores [ Time Frame: 24 hours after the surgery]

    Pain will be assessed at rest and on coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th and 24th hours after surgery.

    24 hours

Study Arms (3)

Thoracic Paravertebral Block

ACTIVE COMPARATOR

In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 20 ml of 0.25% bupivacaine will be injected into this area.

Procedure: Two different block and combination of these two blocks

Erector spinae block

ACTIVE COMPARATOR

Patients who are planned to have an erector spina block will be advanced to the interfacial area under the erector spinae muscle by ultrasound-guided in-plane technique. 20 ml of 0.25% bupivacaine will be injected into this area.

Procedure: Two different block and combination of these two blocks

Thoracic Paravertebral block and Erector spinae Block

ACTIVE COMPARATOR

In patients who are planned to have combined erector spinae block and thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 10 ml of 0.25% bupivacaine will be given to this area. Then, with the same needle, return 1-2 cm from the paravertebral area and inject 10 ml of 0.25% bupivacaine into the interfacial area under the erector spinae muscle.

Procedure: Two different block and combination of these two blocks

Interventions

Two different block and combination of these two blocksPROCEDURE

Thoracic paravertebral block, erector spina block, and a combination of paravertebral block and erector spinae block will be applied to the patients under real-time ultrasound guidance.

Erector spinae blockThoracic Paravertebral BlockThoracic Paravertebral block and Erector spinae Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 80 years old
  • ASA physical status I-II-III
  • BMI 18 to 30 kg/m2
  • Elective video assisted thoracoscopic surgery

You may not qualify if:

  • Patient refusing the procedure
  • Emergency surgery
  • Chronic opioid or analgesic use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Musa Zengin, MD

    Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 18, 2021

Study Start

April 1, 2021

Primary Completion

July 1, 2021

Study Completion

July 13, 2021

Last Updated

July 15, 2021

Record last verified: 2021-07

Locations

TU(1)