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| Name | Class |
|---|---|
| Al-Ahli Hospital, Hebron | UNKNOWN |
| Saint Joseph Hospital, East Jerusalem | UNKNOWN |
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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:
The main questions this clinical trial aims to answer are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| External intercostal nerve block | Experimental | 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. |
|
| Internal intercostal nerve block | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effectiveness of the three approaches of pain management after 3 hours of uniportal VATS | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of the three different approaches of pain management on post-operative hypoxemia | 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yousef Abu Asabeh, M.D. | Contact | +972592949192 | dryousefabuasbeh@gmail.com | |
| Mayar Idkedek, M.D. | Contact | +972523172244 | mayar.idkedek@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yousef Abu Asabeh, M.D. | Thoracic Surgery Department, Al-Ahli Hospital, Palestine | Study Chair |
| Mayar Idkedek, M.D. | Medical Research Club, Faculty of Medicine, Al-Quds University, Jerusalem, Palestine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Joseph Hospital | East Jerusalem | Palestinian Territories |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30422547 | Background | Mehrotra M, D'Cruz JR, Bishop MA, Arthur ME. Video-Assisted Thoracoscopy. 2024 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK532952/ | |
| 8267420 | Background | Kirby TJ, Mack MJ, Landreneau RJ, Rice TW. Initial experience with video-assisted thoracoscopic lobectomy. Ann Thorac Surg. 1993 Dec;56(6):1248-52; discussion 1252-3. doi: 10.1016/0003-4975(93)90661-z. |
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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.
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.
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
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The participants will be given the intercostal nerve block/ catheter directly after the completion of their uniportal VATS, and won't be aware which intervention was given to them in order to accurately measure the participants' level of satisfaction
| Intercostal catheter |
| Active Comparator |
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. |
|
|
| 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. |
|
|
| 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. |
|
| The effectiveness of the three approaches of pain management after uniportal VATS |
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 | 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 |
| From participants enrollment until 3 hours after the uniportal VATS |
| The effect of the three different approaches of pain management on post-operative hypoxemia | 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:
| From participants enrollment until 6 hours after the uniportal VATS |
| The effect of the three different approaches of pain management on post-operative hypoxemia | 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 | 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 | 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:
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 | 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 | 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 |
| Tabarak Al-Masri, M.D. | Medical Research Club, Faculty of Medicine, Al-Quds University, Jerusalem, Palestine | Principal Investigator |
| Al-Ahli Hospital | Hebron | Palestinian Territories |
|
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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