Effecot of Serratus Posterior Superior Intercostal Plane Block and Thoracic Paravertebral Block in VATS

NCT06219369 | Completed

• 1 other identifier: Hitit
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Video-assisted thoracoscopic surgery (VATS) has become a standard procedure in both minor and major lung surgeries in thoracic surgery operations. Although postoperative pain in patients undergoing VATS is not as severe as that seen after thoracotomy, it still occurs. This, in turn, affects postoperative pulmonary complications and patients\' lengths of hospital stay. Thoracic epidural analgesia (TEA) is still considered the gold standard in the treatment of postoperative pain. However, due to side effects such as post-procedural hypotension, urinary retention, or nausea/vomiting, alternative analgesic methods such as thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block (SAPB), erector spinae plane block (ESPB), and serratus posterior superior intercostal plane block (SPSIPB) are being considered instead of epidural analgesia. Among these methods, TPVB performed under ultrasound guidance is already a commonly preferred and classical method. In patients undergoing thoracotomy and VATS, Tulgar and colleagues have defined SPSIPB as a new technique and demonstrated its efficacy in providing analgesia in the hemithorax when considering the sensory dermatome of SPSIPB in a cadaveric and a case series study with five patients conducted in 2023. Similarly, Avcı and colleagues, in their article published in 2023, emphasized the analgesic effectiveness of SPSIPB in the thoracic region after VATS. As far as we know, there is no published study comparing TPVB and SPSIPB under ultrasound guidance to date. Therefore, the aim of this study was to compare ultrasound-guided TPVB and SPSIPB in postoperative analgesia after VATS. Our primary goal is to investigate whether there are any superiority in terms of postoperative Visual analog score (VAS), time to first rescue analgesia, opioid consumption, postoperative nausea and vomiting (PONV) score, and complications, and to determine which one is more effective.

Conditions

Video-assisted Thoracoscopic Surgery

Keywords

thoracic paravertebral block; VATS; serratus posterior superior interkostal plane block

Outcome Measures

Primary Outcomes (1)

• Postoperatative Pain

  Evaluation of patients' post-operative pain levels

  24 hours

Study Arms (2)

Group T

ACTIVE COMPARATOR

Group T patients who underwent TPVB

Procedure: Group T

Group S

ACTIVE COMPARATOR

Group S patients who underwent SPSIPB

Procedure: Group T

Interventions

Group T PROCEDURE

SPSIPB Technique: The SPSIPB block, which follows the guidelines we routinely use, will be performed after the completion of the surgical procedure and before the patient wakes up. TPVB Technique: The US probe (11-12 MHz, Vivid Q) will be placed 2-3 cm lateral to the T5 spinous process. After visualizing the transverse process, the paravertebral area, internal intercostal membrane, paravertebral space, and pleura, the needle will be advanced to the paravertebral space using an in-plane technique.

Also known as: Group S

Group S; Group T

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A minimum of 70 patients who will undergo VATS surgery,
• American Society of Anesthesiologists (ASA) physical classification 1-2-3,
• Aged between 18-65,
• Who have read and accepted the voluntary informed consent form,
• Body mass index (BMI) of \<35.

You may not qualify if:

• Patients who refuse to participate in the study,
• BMI \>35,
• ASA physical classifications 4-5,
• Patients unable to perform pain scoring using the NRS system,
• Those allergic to the administered local anesthetic and designated analgesic medication, individuals declaring pregnancy or lactation,
• Patients under 18 or over 65 years of age,
• Uncontrollable anxiety,
• Alcohol and drug addiction,
• Neuromuscular and peripheral nerve diseases,
• Using high doses of opioid medication three days before surgery,
• Widespread chronic pain,
• Diabetes mellitus,
• Hepatic and renal insufficiency,
• Coagulation disorders,
• Using anticoagulant drugs,

Sponsors & Collaborators

• Hitit University: lead
• Ankara Ataturk Sanatorium Training and Research Hospital: collaborator

Study Sites (1)

Hitit university

Çorum, Çorum, 19100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Sensitivity Training Groups

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Guvenc Dogan, MD

  Hitit Universirty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: SPSIPB Technique: The SPSIPB block, which follows the guidelines we routinely use, will be performed after the completion of the surgical procedure and before the patient wakes up. TPVB Technique: The US probe (11-12 MHz, Vivid Q) will be placed 2-3 cm lateral to the T5 spinous process. After visualizing the transverse process, the paravertebral area, internal intercostal membrane, paravertebral space, and pleura, the needle will be advanced to the paravertebral space using an in-plane technique.

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 23, 2024
• Study Start: January 31, 2024
• Primary Completion: May 20, 2024
• Study Completion: August 15, 2024
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)