Intercostal Nerve Block for Pain Management After Uniportal Video-assisted Thoracoscopic Surgeries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAl-Quds University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All participants between the ages of 18 and 80 year-old who have elective or urgent uniportal VATS will be included in the sample.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
External Intercostal Nerve Block
Other interventionExternal ICNB: A mixture of analgesics will be given through a needle inserted in the intercostal space from outside the chest wall.
Internal Intercostal Nerve Block
Other interventionInternal 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 interventionIntercostal 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: External intercostal nerve blockExperimental treatment 1 intervention
Group B: Internal intercostal nerve blockActive comparator 1 intervention
Group C: Intercostal catheterActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From participants enrollment until 3 hours after the surgery2
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.
Time frame
From participants enrollment until 6 hours after the surgery3
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.
Time frame
From participants enrollment until 24 hours after the surgery4
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.
Time frame
From participants enrollment and during the 24 hours post-operativelySecondary outcomes
1
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: * Mild hypoxaemia - 86-90% * Moderate hypoxaemia - 81-85% * Severe hypoxemia - 76-80% * Extreme hypoxaemia - \<76%
Time frame
From participants enrollment until 3 hours after the uniportal VATS2
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: * Mild hypoxaemia - 86-90% * Moderate hypoxaemia - 81-85% * Severe hypoxemia - 76-80% * Extreme hypoxaemia - \<76%
Time frame
From participants enrollment until 6 hours after the uniportal VATS3
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%
Time frame
From participants enrollment until 24 hours after the uniportal VATS4
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.
Time frame
From participants enrollment until 24 hours after the uniportal VATSSponsors and contacts
Click on the lead sponsor to view all of their trials.
Al-Quds University
Lead sponsor
Al-Ahli Hospital, Hebron
Collaborator
Saint Joseph Hospital, East Jerusalem
Collaborator
Source ClinicalTrials.gov
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