The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia

NCT05357976 — Not applicable, Completed, 75 participants, Ankara City Hospital Bilkent

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The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia Treatment in Patients Undergoing Thoracoscopic Surgery

Registry	NCT05357976
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: quadruple, treatment
Enrollment	75 (Actual)
Sponsor	Ankara City Hospital Bilkent (Other)
Conditions	Pain, Postoperative, Acute Pain, Thoracic Paravertebral Block, Body Mass Index, Thoracic Surgery, Video-Assisted
Interventions	Thoracic Paravertebral Block (Procedure)
Dates	start 2022-04-25, primary completion 2023-05-01, completion 2023-05-13, first posted 2022-05-03, last updated 2023-05-16
Locations	2 sites in Turkey (Türkiye)

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients with a BMI of 18-24.9 kg/m2	Active comparator	Procedure: Thoracic Paravertebral Block	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.
Patients with a BMI of 25-29.9 kg/m2	Active comparator	Procedure: Thoracic Paravertebral Block	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.
Patients with a BMI of 30-40 kg/m2	Active comparator	Procedure: Thoracic Paravertebral Block	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.

Thoracic Paravertebral Block (Procedure): Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.

+Outcome measures

Primary outcomes

Pain Scores [1st hour after surgery.]: Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at the 1st, 2nd, 4th, 12th, 24th, and 48th hours after surgery.
Pain Scores [2nd-hour after surgery.]: Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain Scores [4th-hour after surgery.]: Pain will be assessed at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain Scores [12th-hour after surgery.]: Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain Scores [24th-hour after surgery.]: Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain Scores [48th-hour after surgery.]: Pain will be assessed at the 48th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

Secondary outcomes

Morphine Consumption [24 hours after surgery]: Morphine consumption for 24 hours will be recorded

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Locations (2)

Facility	City	Country	Status
Ankara City Hospital	Çankaya, Ankara	Turkey (Türkiye)
Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital	Keçiören, Ankara	Turkey (Türkiye)

+Publications

Results publication: 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. PMID 37667207

+Investigators

Nilgün Zengin, MD, Principal investigator, Ankara City Hospital Bilkent

My Notes

Public

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