Analgesia, Pain, Postoperative, Satisfaction, Patient, Thoracic
Conditions
Keywords
Intercostal nerve block, Intercostal Catheter, Video-Assisted Thoracoscopic Surgery, Post-operative Pain, Patients' Satisfaction
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.
Interventions
OTHERExternal 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.
OTHERInternal 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.
OTHERIntercostal 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.
Sponsors
Al-Ahli Hospital, Hebron
Saint Joseph Hospital, East Jerusalem
Al-Quds University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effectiveness of the three approaches of pain management after uniportal VATS, during different positions | 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. |
| The effectiveness of the three approaches of pain management after 3 hours of uniportal VATS | 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. |
| The effectiveness of the three approaches of pain management after 6 hours of uniportal VATS | 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. |
| The effectiveness of the three approaches of pain management after 24 hours of uniportal VATS | 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. |
| The effectiveness of the three approaches of pain management after uniportal VATS | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of the three different approaches of pain management on post-operative hypoxemia | 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% |
| The effect of the three different approaches of pain management on post-operative atelectasis | 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. |
| The effect of the three different approaches of pain management on post-operative Pneumothorax | 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. |
| Cost-effectiveness of the three approaches | 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. |
| Participants' satisfaction level | 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 |
Countries
Palestinian Territories
Contacts
Primary ContactYousef Abu Asabeh, M.D.
Backup ContactMayar Idkedek, M.D.
Outcome results
None listed