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ClinicalTrials.gov ID

NCT06838026

Lead Sponsor

Al-Quds UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

90Estimated

Last Update Posted

Apr 1, 2025Actual

Start Date

May 5, 2025Estimated

Primary Completion Date

May 5, 2026Estimated

Completion Date

Dec 5, 2026Estimated

Official Title

Internal, External Intercostal Nerve Block and Intercostal Catheter for Pain Management After Uniportal VATS: A Clinical Trial

Brief Summary

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.

Detailed 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.

• Thoracic
• Pain, Postoperative
• Analgesia
• Satisfaction, Patient

• External Intercostal Nerve Block
• Internal Intercostal Nerve Block
• Intercostal Catheter

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Al-Quds UniversityOTHER

Collaborators

Al-Ahli Hospital, HebronUNKNOWN

Saint Joseph Hospital, East JerusalemUNKNOWN

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