The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia

NCT ID: NCT05357976

Last Updated: 2023-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2023-05-13

Brief Summary

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Obesity has become one of the world's leading health problems. It is known that obesity causes many diseases and negatively affects the quality of life. For this reason, many conditions that are thought to be effective in obesity and concern the quality of life of patients have been scientifically researched and continue to be investigated. One of them is postoperative pain. Although there are studies stating that there is no relationship between body mass index (BMI) and postoperative pain, when the literature data is examined, it is thought that obesity is a risk factor for postoperative pain and changes pain sensitivity and analgesic needs of patients. There are also studies in the literature stating that the level of postoperative pain increases in parallel with each unit increase in BMI.

After thoracic surgery, many analgesic methods have been suggested, including thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), intercostal nerve blocks (ICSB), erector spina plane block (ESPB), serratus anterior plane block (SAPB). This study will compare the effects of BMI on postoperative pain in patients undergoing TPVB for postoperative analgesia and thoracoscopic surgery.

Detailed Description

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Conditions

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Pain, Postoperative Acute Pain Thoracic Paravertebral Block Body Mass Index Thoracic Surgery, Video-Assisted

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Patients with a BMI of 18-24.9 kg/m2

The needle will be advanced to the paravertebral area with an ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.

Group Type ACTIVE_COMPARATOR

Thoracic Paravertebral Block

Intervention Type PROCEDURE

Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.

Patients with a BMI of 25-29.9 kg/m2

The needle will be advanced to the paravertebral area with an ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.

Group Type ACTIVE_COMPARATOR

Thoracic Paravertebral Block

Intervention Type PROCEDURE

Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.

Patients with a BMI of 30-40 kg/m2

The needle will be advanced to the paravertebral area with an ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.

Group Type ACTIVE_COMPARATOR

Thoracic Paravertebral Block

Intervention Type PROCEDURE

Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.

Interventions

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Thoracic Paravertebral Block

Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 to 80 years old
* ASA physical status I-II-III
* BMI 18 to 40 kg/m2
* Elective video-assisted thoracoscopic surgery

Exclusion Criteria

* Patient refusing the procedure
* Emergency surgery
* Chronic opioid or analgesic use
* Patients who will operate under emergency conditions
* Patients who will not undergo VATS
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Nilgün Zengin

Principal İnvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nilgün Zengin, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

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Ankara City Hospital

Çankaya, Ankara, Turkey (Türkiye)

Site Status

Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital

Keçiören, Ankara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Zengin EN, Alagoz A, Yigit H, Sazak H, Sekerci S, Zengin M. The effect of body mass index on thoracic paravertebral block analgesia after video-assisted thoracoscopic surgery; a prospective interventional study. BMC Anesthesiol. 2023 Sep 4;23(1):297. doi: 10.1186/s12871-023-02264-0.

Reference Type DERIVED
PMID: 37667207 (View on PubMed)

Other Identifiers

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E.Kurul-E1-22-2596

Identifier Type: -

Identifier Source: org_study_id

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