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

Primary Purpose

Analgesia, Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
paravertebral block group
Mid point transverse process block group
Control group
Sponsored by
Uludag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Analgesia focused on measuring thoracic, analgesia, post operative pain, surgery-complication

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bursa Uludag University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control group

paravertebral block group

mid transverse process block group

Arm Description

group receiving general anesthesia only

received single-shot paravertebral block after induction of anesthesia.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 29, 2023
Last Updated
October 12, 2023
Sponsor
Uludag University
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1. Study Identification

Unique Protocol Identification Number
NCT06089512
Brief Title
Comparison of Midpoint Transverse Process to Pleura Block and Thoracic Paravertebral Block
Official Title
Comparison of Midpoint Transverse Process to Pleura Block and Thoracic Paravertebral Block for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery (VATS)"
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
August 15, 2023 (Actual)
Study Completion Date
August 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uludag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Post Operative Pain
Keywords
thoracic, analgesia, post operative pain, surgery-complication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
group receiving general anesthesia only
Arm Title
paravertebral block group
Arm Type
Active Comparator
Arm Description
received single-shot paravertebral block after induction of anesthesia.
Arm Title
mid transverse process block group
Arm Type
Active Comparator
Arm Description
received a mid-transverse process -to- pleura block after induction of anesthesia.
Intervention Type
Procedure
Intervention Name(s)
paravertebral block group
Intervention Description
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
Intervention Name(s)
Mid point transverse process block group
Intervention Description
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
Intervention Name(s)
Control group
Intervention Description
Only general anesthesia was applied to the patients.
Primary Outcome Measure Information:
Title
Intraoperative analgesic effects of peripheral blocks
Description
Investigators will compare the intraoperative analgesic effects by opioid consumption in intraoperative phase.
Time Frame
First day
Title
Postoperative analgesic effects of peripheral blocks
Description
Visual Analogue Scale (VAS) will be used for postoperative analgesic effects.
Time Frame
First day
Secondary Outcome Measure Information:
Title
opioid consumed through PCA (patient controlled analgesia)
Description
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.
Time Frame
first day
Title
Side effects
Description
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.
Time Frame
First day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
seda cansabuncu
Organizational Affiliation
BURSA ULUDAG UNIVERSITY HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bursa Uludag University
City
Bursa
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
we plan share ,study Protocol, statistical Analysis Plan (SAP), informed Consent Form (ICF)

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

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