Clinical trial NCT06838026: Intercostal Nerve Block for Pain Management After Uniportal Video-assisted Thoracoscopic Surgeries
Official title: Internal, External Intercostal Nerve Block and Intercostal Catheter for Pain Management After Uniportal VATS: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thoracic
Pain, Postoperative
Analgesia
Satisfaction, Patient
Keywords: Intercostal nerve block
Intercostal Catheter
Video-Assisted Thoracoscopic Surgery
Post-operative Pain
Patients' Satisfaction
Lead sponsor: Al-Quds University
Sponsor class: OTHER
Collaborators: name: Al-Ahli Hospital, Hebron
name: Saint Joseph Hospital, East Jerusalem
First posted: 2025-02-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 outcomes:
measure: The effectiveness of the three approaches of pain management after 3 hours of uniportal VATS
timeFrame: From participants enrollment until 3 hours after the surgery
measure: The effectiveness of the three approaches of pain management after 6 hours of uniportal VATS
timeFrame: From participants enrollment until 6 hours after the surgery
measure: The effectiveness of the three approaches of pain management after 24 hours of uniportal VATS
timeFrame: From participants enrollment until 24 hours after the surgery
measure: The effectiveness of the three approaches of pain management after uniportal VATS
timeFrame: From participants enrollment and during the 24 hours post-operatively
measure: The effectiveness of the three approaches of pain management after uniportal VATS, during different positions
timeFrame: 24 hours post-operatively
Secondary outcomes:
measure: The effect of the three different approaches of pain management on post-operative hypoxemia
timeFrame: From participants enrollment until 3 hours after the uniportal VATS
measure: The effect of the three different approaches of pain management on post-operative hypoxemia
timeFrame: From participants enrollment until 6 hours after the uniportal VATS
measure: The effect of the three different approaches of pain management on post-operative hypoxemia
timeFrame: From participants enrollment until 24 hours after the uniportal VATS
measure: The effect of the three different approaches of pain management on post-operative atelectasis
timeFrame: From participants enrollment until 24 hours after the uniportal VATS
measure: The effect of the three different approaches of pain management on post-operative Pneumothorax
timeFrame: From participants enrollment until 24 hours after the uniportal VATS
measure: Cost-effectiveness of the three approaches
timeFrame: From participants enrollment until the study completion, an average of 7 months
measure: Participants' satisfaction level
timeFrame: From participants enrollment until 24 hours after the uniportal VATS
Other outcomes:
Locations:
city: East Jerusalem
country: Palestinian Territory, occupied
facility: Saint Joseph Hospital
city: Hebron
country: Palestinian Territory, occupied
facility: Al-Ahli Hospital
Study officials:
affiliation: Thoracic Surgery Department, Al-Ahli Hospital, Palestine
name: Yousef Abu Asabeh, M.D.
role: STUDY_CHAIR
affiliation: Medical Research Club, Faculty of Medicine, Al-Quds University, Jerusalem, Palestine
name: Mayar Idkedek, M.D.
role: STUDY_DIRECTOR
affiliation: Medical Research Club, Faculty of Medicine, Al-Quds University, Jerusalem, Palestine
name: Tabarak Al-Masri, M.D.
role: PRINCIPAL_INVESTIGATOR
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