Intercostal Nerve Block for Pain Management After Uniportal Video-assisted Thoracoscopic Surgeries (VATS)

Al-Quds University

Status: Not yet enrolling

Conditions: Thoracic; Pain, Postoperative; Analgesia; Satisfaction, Patient

Treatments: Other: Internal Intercostal Nerve Block; Other: Intercostal Catheter; Other: External Intercostal Nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06838026

20222023

Details and patient eligibility

About

The goal of this clinical trial is to compare the safety and effectiveness of the three intercostal nerve blocks used in pain management in uniportal (one port) thoracoscopic surgeries: internal intercostal nerve blocks (ICNB), external ICNB, and Intercostal catheters.

Participants will be randomly assigned to three groups:

• First group will undergo internal intercostal nerve block
• Second group will be given external intercostal nerve block
• Third group will have an intercostal catheter Researchers will compare the three groups to see their impact on post-operative pain management in uniportal VATS.

Full description

The main questions this clinical trial aims to answer are:

1. To study post-VATS complications, such as: postoperative air leak, post-operative pain, hypoxemia, atelectasis, bleeding, wound infection, pneumonia, Deep Vein Thrombosis, pulmonary embolism and their association with the different approaches of ICNBs.
2. To address the cost-effectiveness of the intercostal nerve block approaches.
3. To study the participants' level of satisfaction after VATS following each procedure of ICNB.
4. To address the relationships between the intercostal nerve block approaches and participants' characteristics such as age, gender, BMI, medical and surgical history, smoking, and alcohol history.

This study is a randomized controlled trial that will take place at Al-Ahli Hospital and Saint Joseph Hospital. The trial will involve 90 participants, who will be randomly assigned to three groups. Of these, group 1 will include 30 participants who'll receive an internal intercostal nerve block, group 2: 30 participants will receive an external intercostal block, and group 3 are the 30 participants who will have an intercostal catheter inserted.

Data will be collected from the participants' themselves through a questionnaire before the surgery. The participants will be followed up after the surgery (3, 6, 24 hours post-operatively) in order to obtain the numerical rating scale. A written informed consent will be sought.

Data Analysis will be done through International Business Machines (IBM) Statistical Package for Social Sciences (SPSS) for Windows Version 16.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All participants between the ages of 18 and 80 year-old who have elective or urgent uniportal VATS will be included in the sample.

Exclusion criteria

• Children - under the age of 18 or participants above the age of 80.
• Participants with chest wall infections and those with decorticated lungs will be excluded from the study.
• Participants with pre-existing chest pain or severe renal or hepatic dysfunction
• Participants with a history of psychiatric disorder or inability to understand the consent form or how to use a Numerical Rating Scale (NRS) for pain measurement
• Participants who have allergy to any of the given drugs, second thoracic surgery, participation in other clinical trials, obesity with body mass index>35 kg/m2, intake of antiplatelet or anticoagulant agents, spinal deformity and severe bradycardia will also be excluded.
• Participants will be withdrawn from the study if the technical failure happened in the block or VATS procedure was converted to open procedure.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

External intercostal nerve block

Experimental group

Description:

30 participants will be randomised for the External Intercostal block will receive a mixture of analgesics (Marcaine 3mg /kg 0.5%, Lidocaine 2% 10 cc, Dexamethasone 4 mg, 30 cc of Normal Saline (NS) 0.9%, through: Identifying the targeted intercostal spaces: The 3rd-7th by applying digital palpation and indentation of these spaces using the surgeon's fingers and the camera. After identifying the desired spaces, they will use 10 cc syringe connected to 23 Gauge needs, the needle will be applied externally into the chest wall, advancing it with negative pressure, making sure to keep the needle perpendicular to the chest wall to avoid injury to the intercostal neurovascular bundle, advancing the needle while keeping negative pressure, and being closer to the upper border of the ribs. Once the indentation of needle into the pleural is seen, they aspirate again to make sure that they are not into blood vessels, then they will inject 8 cc into each intercostal space.

Treatment:

Other: External Intercostal Nerve Block

Internal intercostal nerve block

Active Comparator group

Description:

30 participants will be randomised for the Internal Intercostal block will receive a mixture of analgesics (the investigators will use a mixture of local analgesics containing: Marcaine 3mg /kg 0.5%, Lidocaine 2% 10 cc, Dexamethasone 4 mg, 30 cc of Normal Saline (NS) 0.9%), through: -Using the blue color butterfly needle, 23 gauge, The needle will be introduced into the thoracic cavity under the thoracoscopic control and vision, Identification of the intercostal spaces: The third down to the seventh, total of 5 intercostal spaces, the needle will be introduced under vision into the intercostal spaces, avoiding the intercostal artery or veins, aspiration to make sure that they are not into blood vessels, then 10 injecting 8 cc of the analgesic mixture into each of the intercostal spaces, making sure to see the pleura over the intercostal space bulging to indicate that the analgesic is not injected into deeper muscular layers.

Treatment:

Other: Internal Intercostal Nerve Block

Intercostal catheter

Active Comparator group

Description:

30 Participants will be randomised for the Intercostal Catheter, the investigators will use an epidural catheter set, they will apply the catheter to one - two intercostal spaces higher that the VATS incision. The investigators will start by applying the needle from outside, into the desired intercostal space, once they see the indentation of the needle. They will inject 5 - 10 cc of normal saline to distend the intercostal space, then they will remove the stylet part and they will introduce the catheter, after making sure that there is at least 3 centimeter of the catheter into the intercostal space, they will remove the needle, making sure not to move the catheter, then they will tunnel the catheter under the skin for 2 cm , the participant will receive the 15 cc of the previously mentioned mixture every 8 hours for two to three days.

Treatment:

Other: Intercostal Catheter