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

Comparison of Midpoint Transverse Process to Pleura Block and Thoracic Paravertebral Block for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery (VATS)"

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Post Operative Pain
• Intervention / Treatment: Procedure: Control group; Procedure: paravertebral block group; Procedure: Mid point transverse process block group

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey
    • Bursa Uludag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; group receiving general anesthesia only	Procedure: Control group; Only general anesthesia was applied to the patients.
Active Comparator: paravertebral block group; received single-shot paravertebral block after induction of anesthesia.	Procedure: 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.
Active Comparator: mid transverse process block group; received a mid-transverse process -to- pleura block after induction of anesthesia.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative analgesic effects of peripheral blocks	Investigators will compare the intraoperative analgesic effects by opioid consumption in intraoperative phase.	First day
Postoperative analgesic effects of peripheral blocks	Visual Analogue Scale (VAS) will be used for postoperative analgesic effects.	First day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumed through PCA (patient controlled analgesia)	PCA was used for pain control. An iv solution was prepared to all participants with 100 mg morphine hydrochloride at a concentration of 1 mg/ml in 90 ml saline and the bolus dose was set as 2 ml and the locked time as 15 min. From the recovery unit, a bolus dose of morphine was administered with the PCA device if VAS≥4 by questioning or upon the request of the participants. Participants who had VAS≥4 despite PCA were administered 50 mg dexketoprofen iv as rescue analgesic and 50 mg tramadol intramuscularly as the second rescue analgesic if VAS≥4 continued.	first day
Side effects	The necessity for supplementary analgesics, any complications associated with the puncture procedure such as infection, hematoma, and pneumothorax (confirmed via direct thoracoscopic visualization), the incidence of postoperative nausea and vomiting.	First day

Collaborators and Investigators

• Sponsor: Uludag University
• Investigators: Principal Investigator: seda cansabuncu, Bursa Uludag University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 20, 2023

Study Registration Dates

• First Submitted: September 29, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: post operative pain; analgesia; thoracic; surgery-complication
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2022-17/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: we plan share ,study Protocol, statistical Analysis Plan (SAP), informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No