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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06089512
• Other study ID #: 2022-17/22
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: August 20, 2023

Study information

• Verified date: October 2023
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 20, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative
• Post Operative Pain

Intervention

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.
• 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.
• Control group
Only general anesthesia was applied to the patients.

Locations

Country	Name	City	State
Turkey	Bursa Uludag University	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

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