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NCT Number: NCT06838026

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

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.

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Key information

Conditions

Thoracic Agnosia Analgesia Behavior Health Behavior Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Satisfaction Perceptual Disorders Postoperative Complications Satisfaction, Patient Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph Hospital, East Jerusalem, Palestinian Territories

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About this study

The main questions this clinical trial aims to answer are:

  • 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.
  • To address the cost-effectiveness of the intercostal nerve block approaches.
  • To study the participants' level of satisfaction after VATS following each procedure of ICNB.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

External Intercostal Nerve Block

Other

External ICNB: A mixture of analgesics will be given through a needle inserted in the intercostal space from outside the chest wall.

Other names: External ICNB

Internal Intercostal Nerve Block

Other

Internal ICNB: A mixture of analgesics will be given through a needle inserted in the intercostal space inside the chest wall under direct thoracoscopic vision.

Other names: Internal ICNB

Intercostal Catheter

Other

Intercostal Catheter: it will be put 1-2 intercostal spaces above the VATS incision, and the participant will receive the 15 cc of the previously mentioned mixture every 8 hours for two to three days.

Primary outcomes

  1. The effectiveness of the three approaches of pain management after 3 hours of uniportal VATS

    Time frame: From participants enrollment until 3 hours after the surgery

    To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS through assessing the pain scores of the participants 3 hours after the surgery using the Numerical rating scale (NRS11).

    The NRS is a 11-point scale, where "0" represents "no pain", and "10" represents "the most severe pain imaginable" at 3 hours after the uniportal VATS.

    Points from "1 - 3" means mild pain, "4 - 6" indicates moderate pain, and "7 - 10" indicates severe pain.

  2. The effectiveness of the three approaches of pain management after 6 hours of uniportal VATS

    Time frame: From participants enrollment until 6 hours after the surgery

    To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS through assessing the pain scores of the participants 6 hours after the surgery using the Numerical rating scale (NRS11).

    The NRS is a 11-point scale, where "0" represents "no pain", and "10" represents "the most severe pain imaginable" at 6 hours after the uniportal VATS.

    Points from "1 - 3" means mild pain, "4 - 6" indicates moderate pain, and "7 - 10" indicates severe pain.

  3. The effectiveness of the three approaches of pain management after 24 hours of uniportal VATS

    Time frame: From participants enrollment until 24 hours after the surgery

    To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS through assessing the pain scores of the participants 24 hours after the surgery using the Numerical rating scale (NRS11).

    The NRS is a 11-point scale, where "0" represents "no pain", and "10" represents "the most severe pain imaginable" at 24 hours after the uniportal VATS.

    Points from "1 - 3" means mild pain, "4 - 6" indicates moderate pain, and "7 - 10" indicates severe pain.

  4. The effectiveness of the three approaches of pain management after uniportal VATS

    Time frame: From participants enrollment and during the 24 hours post-operatively

    To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS through assessing the participants' use of opioids, during the 24 hours post-operatively.

  5. The effectiveness of the three approaches of pain management after uniportal VATS, during different positions

    Time frame: 24 hours post-operatively

    To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS, during coughing, deep breathing, lying down, moving and chest tube removal, through the use of NRS11, 24 hours post-operatively.

    The NRS is a 11-point scale, where "0" represents "no pain", and "10" represents "the most severe pain imaginable" at the three different positions.

    Points from "1 - 3" means mild pain, "4 - 6" indicates moderate pain, and "7 - 10" indicates severe pain.

Secondary outcomes

  1. The effect of the three different approaches of pain management on post-operative hypoxemia

    Time frame: From participants enrollment until 3 hours after the uniportal VATS

    Understand the relationships between different approaches of pain management used and post-operative hypoxemia after each approach.

    Hypoxemia is defined as hypoperfusion or low oxygen concentrations in the artery that leads to a decrease the delivery of oxygen to the tissues. It will be measured using pulse oximetry at 3 hours, and compared to the patient's baseline before the surgery.

    The use of pulse oximeter will help in the early diagnosis of hypoxemia, and lead to early correction if it is present.

    Hypoxaemia will be graded as follows:

    • Mild hypoxaemia - 86-90%
    • Moderate hypoxaemia - 81-85%
    • Severe hypoxemia - 76-80%
    • Extreme hypoxaemia - <76%

  2. The effect of the three different approaches of pain management on post-operative hypoxemia

    Time frame: From participants enrollment until 6 hours after the uniportal VATS

    Understand the relationships between different approaches of pain management used and post-operative hypoxemia after each approach.

    Hypoxemia is defined as hypoperfusion or low oxygen concentrations in the artery that leads to a decrease the delivery of oxygen to the tissues. It will be measured using pulse oximetry at 6 hours, and compared to the patient's baseline before the surgery.

    The use of pulse oximeter will help in the early diagnosis of hypoxemia, and lead to early correction if it is present.

    Hypoxaemia will be graded as follows:

    • Mild hypoxaemia - 86-90%
    • Moderate hypoxaemia - 81-85%
    • Severe hypoxemia - 76-80%
    • Extreme hypoxaemia - <76%

  3. The effect of the three different approaches of pain management on post-operative hypoxemia

    Time frame: From participants enrollment until 24 hours after the uniportal VATS

    Understand the relationships between different approaches of pain management used and post-operative hypoxemia after each approach.

    Hypoxemia is defined as hypoperfusion or low oxygen concentrations in the artery that leads to a decrease the delivery of oxygen to the tissues. It will be measured using pulse oximetry at 24 hours, and compared to the patient's baseline before the surgery.

    The use of pulse oximeter will help in the early diagnosis of hypoxemia, and lead to early correction if it is present.

    Hypoxaemia will be graded as follows:

    Mild hypoxaemia - 86-90% Moderate hypoxaemia - 81-85% Severe hypoxemia - 76-80% Extreme hypoxaemia - <76%

  4. The effect of the three different approaches of pain management on post-operative atelectasis

    Time frame: From participants enrollment until 24 hours after the uniportal VATS

    Understand the relationships between different approaches of pain management used and post-operative atelectasis after each approach.

    Atelectasis will be defined as collapse or incomplete expansion of the pulmonary parenchyma.

    The incidence of atelectasis in each approach will be identified through chest x-ray that will be done immediately after the surgery and repeated 24 hours later.

    The signs of atelectasis on chest X-ray that will be considered are: increased opacity of the atelectatic segment, displacement of inter-lobar fissures towards the atelectatic segment, upward displacement of the diaphragm ipsilateral of atelectatic segment and crowding of pulmonary vessels and bronchi in atelectatic segment. Other signs that will be considered are: over-inflation of the healthy lung and displacement of trachea and other thoracic structures towards the side of atelectasis.

  5. The effect of the three different approaches of pain management on post-operative Pneumothorax

    Time frame: From participants enrollment until 24 hours after the uniportal VATS

    Understand the relationships between different approaches of pain management used and post-operative pneumothorax after each approach.

    Pneumothorax will be defined as a condition when air in the lung leak in the pleural cavity (following the surgical procedure).

    Pneumothorax will be diagnosed through a chest x-ray, which is the gold standard for the detection of pneumothorax.

    Pneumothorax will be classified as the following:

    • Small pneumothorax: when the space is less than 2 cm, measured from the chest wall to the edge of the lung at the level of the hilum on chest x-ray.
    • Large pneumothorax: when the space is larger than 2 cm, measured from the chest wall to the edge of the lung at the level of the hilum on chest x-ray.

    This outcome will be identified through chest x-ray that will be done immediately after the surgery and repeated 24 hours later to look for any new pneumothorax onset during the first 24 hours post-operation.

  6. Cost-effectiveness of the three approaches

    Time frame: From participants enrollment until the study completion, an average of 7 months

    The cost-effectiveness of the 3 approaches will be measured through relying on the pain Medication as a Cost Factor: The cost-effectiveness of the three analgesic approaches will be estimated by analyzing the consumption of additional pain medications. This includes both opioids and non-opioids. The total amount of additional pain medications administered to each patient will be calculated as a proxy for cost. This approach assumes that higher medication requirements correlate with lower effectiveness of the approach, thereby affecting the overall cost-effectiveness. The average medication costs across the three groups will be compared to determine the most cost-effective approach.

  7. Participants' satisfaction level

    Time frame: From participants enrollment until 24 hours after the uniportal VATS

    Identify the Participants' satisfaction level after each approach through a linear scale from 1 to 10 used in the questionnaire (The question will be: How satisfied had you been with the results of your pain treatment while in the hospital?)

    1 means completely unsatisfied, 10 means completely satisified

Study contacts

Contact information is provided by the study sponsor or research team.

Mayar Idkedek, M.D.

CONTACT

[email protected]

+972523172244

Yousef Abu Asabeh, M.D.

CONTACT

[email protected]

+972592949192

Sponsors and collaborators

Lead sponsor

Al-Quds University

Other

Collaborators

  • Al-Ahli Hospital, Hebron
  • Saint Joseph Hospital, East Jerusalem

Registry information

Official study title

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

Acronym: VATS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2025
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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