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

March 26, 2025 updated by: Al-Quds University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Palestinian Territory, occupied
      • East Jerusalem, Palestinian Territory, occupied
      • Hebron, Palestinian Territory, occupied
        • Al-Ahli hospital
        • Contact:
        • Contact:
        • Contact:
          • Tabarak Al-Masri, M.D.
        • Contact:
          • Alaaeddin Hliqawi, M.D.
        • Contact:
          • Athar Mustafa
        • Contact:
          • Tasneem Shalaan
        • Contact:
          • Esraa Kurdi
        • Contact:
          • Malik Itmaiza
        • Contact:
          • Hadeel Ayesh, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: External intercostal nerve block
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.
Other: External Intercostal Nerve Block
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
Active Comparator: Internal intercostal nerve block

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.
Other: Internal Intercostal Nerve Block
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
Active Comparator: Intercostal catheter
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.
Other: Intercostal Catheter
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From participants enrollment until 3 hours after the surgery
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.
From participants enrollment until 6 hours after the surgery
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.
From participants enrollment until 24 hours after the surgery
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.
From participants enrollment and during the 24 hours post-operatively
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.
24 hours post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
From participants enrollment until 3 hours after the uniportal VATS
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%
From participants enrollment until 6 hours after the uniportal VATS
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%
From participants enrollment until 24 hours after the uniportal VATS
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.
From participants enrollment until 24 hours after the uniportal VATS
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.
From participants enrollment until 24 hours after the uniportal VATS
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.
From participants enrollment until the study completion, an average of 7 months
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
From participants enrollment until 24 hours after the uniportal VATS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Quds University

Collaborators

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

Investigators

  • Study Chair: Yousef Abu Asabeh, M.D., Thoracic Surgery Department, Al-Ahli Hospital, Palestine
  • Study Director: Mayar Idkedek, M.D., Medical Research Club, Faculty of Medicine, Al-Quds University, Jerusalem, Palestine
  • Principal Investigator: Tabarak Al-Masri, M.D., Medical Research Club, Faculty of Medicine, Al-Quds University, Jerusalem, Palestine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 5, 2025

Primary Completion (Estimated)

May 5, 2026

Study Completion (Estimated)

December 5, 2026

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20222023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in the final published article, after deidentification (text, tables, figures, and appendices) will be shared beginning 3 months and ending 5 years following article publication. Extensions will be considered on a case-by-case basis.

IPD Sharing Time Frame

Data requests can be submitted starting 3 months and ending 5 years following article publication, extensions will be considered on a case-by-case basis.

IPD Sharing Access Criteria

Access to trial Sharing statement can be requested by qualified researchers engaging in scientific research, interested in the field of the trial, and whose proposed use of the data has been approved by an independent review committee.

Access will be provided following review and approval of a research proposal, Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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