Comparison of Midpoint Transverse Process to Pleura Block and Thoracic Paravertebral Block

NCT ID: NCT06089512

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-08-20

Brief Summary

In this study, hypothesis is that the MTPB (mid point transverse process block), which is easier and has fewer complications in patients aged 18-80 undergoing video-assisted thoracic surgery (VATS), provides analgesia as effective as PVB.

Detailed Description

Patients between the ages of 18 to 80, scheduled for Video-Assisted Thoracoscopic Surgery (VATS) and classified under the American Society of Anesthesiologists (ASA) class I and II, will be included in the study. Patients with known or suspected local anesthetic allergies, coagulopathy, site injection infections, a history of thoracic surgery, severe neurological or psychiatric disorders, severe cardiovascular diseases, liver failure, kidney failure (glomerular filtration rate <15 ml/min/1.73 m2), and chronic opioid use will be excluded from the study.

Demographic information of the patients (name, protocol number, weight, height, age, body mass index, comorbidities, ASA score) will be recorded. Subsequently, after necessary information is provided, and written and verbal consent is obtained, patients will be randomized into three groups:

Group MTPB: After the induction of general anesthesia and intubation in the operating room, the patient will be placed in the lateral decubitus position. Using ultrasound guidance, a linear probe will be used to perform a MTPB at the midpoint of the superior costotransverse ligament at the level of the 5th intercostal space. A 0.5 ml/kg solution of 0.25% bupivacaine will be administered in-plane.

Group PVB: After the induction of general anesthesia and intubation in the operating room, the patient will be placed in the lateral decubitus position. Using ultrasound guidance, a linear probe will be used to perform a paravertebral block (PVB) at the level of the 5th intercostal space. A 0.5 ml/kg solution of 0.25% bupivacaine will be administered in-plane.

Group P: No peripheral block will be performed in this group.

All patients' hemodynamic data (mean arterial pressure, heart rate, oxygen saturation) will be recorded at 30-minute intervals during the intraoperative period, as well as the amount of opioids used during the surgery. Fifteen minutes before awakening, an intravenous patient-controlled analgesia (PCA) device will be connected, delivering a bolus dose of 2 ml of 1 mg/ml morphine solution with a lockout time of 15 minutes.

During the postoperative period, visual analog pain scores (VAS) will be assessed at 0, 30 minutes, 1, 2, 4, 8, 12, 24, 36, and 48 hours, both at rest and during coughing. Additionally, the time to first analgesic requirement, total analgesic consumption, need for rescue analgesia (contramal 100 mg/2 ml), amount required, possible opioid side effects (nausea, vomiting, respiratory depression, sedation), and time to awakening will be recorded.

The time to first mobilization, postoperative complications, time to discharge, and satisfaction of both patients and the surgical team will be recorded using a 5-point Likert scale.

Conditions

Analgesia; Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control group

group receiving general anesthesia only

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: PROCEDURE

Only general anesthesia was applied to the patients.

paravertebral block group

received single-shot paravertebral block after induction of anesthesia.

Group Type: ACTIVE_COMPARATOR

paravertebral block group

Intervention Type: PROCEDURE

Paravertebral block was applied to the patients after induction of general anesthesia; Intraoperative opioid requirement and postoperative pain scores and analgesic requirement were evaluated.

mid transverse process block group

received a mid-transverse process -to- pleura block after induction of anesthesia.

Group Type: ACTIVE_COMPARATOR

Mid point transverse process block group

Intervention Type: PROCEDURE

Mid point transverse process block was applied to the patients after induction of general anesthesia; Intraoperative opioid requirement and postoperative pain scores and analgesic requirement were evaluated.

Interventions

paravertebral block group

Paravertebral block was applied to the patients after induction of general anesthesia; Intraoperative opioid requirement and postoperative pain scores and analgesic requirement were evaluated.

Intervention Type: PROCEDURE

Mid point transverse process block group

Mid point transverse process block was applied to the patients after induction of general anesthesia; Intraoperative opioid requirement and postoperative pain scores and analgesic requirement were evaluated.

Intervention Type: PROCEDURE

Control group

Only general anesthesia was applied to the patients.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients between 18 and 80 years of age
• American Society of Anesthesiologists I-II physical status of and
• Body mass index of 19 to 28 kg/m2

Exclusion Criteria

• Patients who had coagulopathy
• Previous thoracic surgery
• Emotional instability
• Significant encephalopathy
• Preexisting motor or sensory deficit
• Other contraindications to local anaesthesia, such as allergies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uludag University

OTHER

Sponsor Role: lead

Responsible Party

Seda Cansabuncu

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

seda cansabuncu

Role: PRINCIPAL_INVESTIGATOR

BURSA ULUDAG UNIVERSITY HOSPITAL

Locations

Bursa Uludag University

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022-17/22

Identifier Type: -

Identifier Source: org_study_id