ThoracicVATSNCT06838026
Intercostal Nerve Block for Pain Management After Uniportal Video-assisted Thoracoscopic Surgeries
A study testing External Intercostal Nerve Block, Internal Intercostal Nerve Block and Intercostal Catheter in people with Thoracic and Pain, Postoperative, run by Al-Quds University at 2 sites in Palestinian Territories.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracic, Pain, Postoperative, Analgesia
- What is being tested?
- External Intercostal Nerve Block, Internal Intercostal Nerve Block and Intercostal Catheter
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesPalestinian Territories
- Study dates
- 5 May 2025to 5 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants between the ages of 18 and 80 year-old who have elective or urgent uniportal VATS will be included in the sample.
Who cannot join
- 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- Participants will be withdrawn from the study if the technical failure happened in the block or VATS procedure was converted to open procedure.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Palestinian Territories2 sites
Saint Joseph Hospital
East Jerusalem
Yousef Abu Asabeh, M.D., +972592949192, dryousefabuasbeh@gmail.com
Mayar Idkedek, M.D., +972523172244, mayar.idkedek@gmail.com
Al-Ahli Hospital
Hebron
Yousef Abu Asabeh, M.D., +972592949192, dryousefabuasbeh@gmail.com
Mayar Idkedek, M.D., +972523172244, mayar.idkedek@gmail.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Thoracic, Pain, Postoperative, Analgesia, Satisfaction, Patient
- Being tested
- External Intercostal Nerve Block, Internal Intercostal Nerve Block, Intercostal Catheter
- Keywords
- Intercostal nerve block, Intercostal Catheter, Video-Assisted Thoracoscopic Surgery, Post-operative Pain, Patients' Satisfaction
- Medical subject headings
- Pain, Postoperative, Agnosia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Intercostal Nerve BlockOther
Also called External ICNB
External ICNB: A mixture of analgesics will be given through a needle inserted in the intercostal space from outside the chest wall.
Internal Intercostal Nerve BlockOther
Also called Internal ICNB
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 CatheterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: External Intercostal Nerve Block |
| 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. Receives: Other: Internal Intercostal Nerve Block |
| 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. Receives: Other: Intercostal Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From participants enrollment until 24 hours after the surgery
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.
Measured: 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.
Measured: 24 hours post-operatively
Secondary outcomes (7)
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%
Measured: 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:
- Mild hypoxaemia - 86-90%
- Moderate hypoxaemia - 81-85%
- Severe hypoxemia - 76-80%
- Extreme hypoxaemia - <76%
Measured: 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%
Measured: 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.
Measured: 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:
- 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.
Measured: 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.
Measured: 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
Measured: From participants enrollment until 24 hours after the uniportal VATS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start5 May 2025 (estimated)
- Primary completion5 May 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for ThoracicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Quds University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Ahli Hospital, Hebron, Saint Joseph Hospital, East Jerusalem
- Responsible party
- Sponsor
- Investigators
- Yousef Abu Asabeh, M.D., Study chair, Thoracic Surgery Department, Al-Ahli Hospital, PalestineMayar Idkedek, M.D., Study director, Medical Research Club, Faculty of Medicine, Al-Quds University, Jerusalem, PalestineTabarak Al-Masri, M.D., Principal investigator, Medical Research Club, Faculty of Medicine, Al-Quds University, Jerusalem, Palestine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838026
- Sponsor's protocol ID
- 20222023
- Acronym
- VATS
- Status last verified
- Feb 2025
- First submitted
- 24 Apr 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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/
PubMed 30422547Kirby 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.
PubMed 8267420Rocco G, Martin-Ucar A, Passera E. Uniportal VATS wedge pulmonary resections. Ann Thorac Surg. 2004 Feb;77(2):726-8. doi: 10.1016/S0003-4975(03)01219-0.
PubMed 14759479Kim S, Bae CM, Do YW, Moon S, Baek SI, Lee DH. Serratus Anterior Plane Block and Intercostal Nerve Block after Thoracoscopic Surgery. Thorac Cardiovasc Surg. 2021 Sep;69(6):564-569. doi: 10.1055/s-0040-1705152. Epub 2020 Mar 29.
PubMed 32222960Feray S, Lubach J, Joshi GP, Bonnet F, Van de Velde M; PROSPECT Working Group *of the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guidelines for video-assisted thoracoscopic surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2022 Mar;77(3):311-325. doi: 10.1111/anae.15609. Epub 2021 Nov 5.
PubMed 34739134Detterbeck FC. Efficacy of methods of intercostal nerve blockade for pain relief after thoracotomy. Ann Thorac Surg. 2005 Oct;80(4):1550-9. doi: 10.1016/j.athoracsur.2004.11.051.
PubMed 16181921Guerra-Londono CE, Privorotskiy A, Cozowicz C, Hicklen RS, Memtsoudis SG, Mariano ER, Cata JP. Assessment of Intercostal Nerve Block Analgesia for Thoracic Surgery: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Nov 1;4(11):e2133394. doi: 10.1001/jamanetworkopen.2021.33394.
PubMed 34779845Okmen K, Okmen BM, Uysal S. Serratus Anterior Plane (SAP) Block Used for Thoracotomy Analgesia: A Case Report. Korean J Pain. 2016 Jul;29(3):189-92. doi: 10.3344/kjp.2016.29.3.189. Epub 2016 Jul 1.
PubMed 27413485Reyad RM, Shaker EH, Ghobrial HZ, Abbas DN, Reyad EM, Abd Alrahman AAM, Al-Demery A, Issak ERH. The impact of ultrasound-guided continuous serratus anterior plane block versus intravenous patient-controlled analgesia on the incidence and severity of post-thoracotomy pain syndrome: A randomized, controlled study. Eur J Pain. 2020 Jan;24(1):159-170. doi: 10.1002/ejp.1473. Epub 2019 Sep 6.
PubMed 31433893Joshi GP, Bonnet F, Shah R, Wilkinson RC, Camu F, Fischer B, Neugebauer EA, Rawal N, Schug SA, Simanski C, Kehlet H. A systematic review of randomized trials evaluating regional techniques for postthoracotomy analgesia. Anesth Analg. 2008 Sep;107(3):1026-40. doi: 10.1213/01.ane.0000333274.63501.ff.
PubMed 18713924Grogan EL, Jones DR. VATS lobectomy is better than open thoracotomy: what is the evidence for short-term outcomes? Thorac Surg Clin. 2008 Aug;18(3):249-58. doi: 10.1016/j.thorsurg.2008.04.007.
PubMed 18831499Abd-Elshafy SK, Abdallal F, Kamel EZ, Edwar H, Allah EA, Maghraby HHM, Sayed JA, Ali MS, Elkhayat H, Mahran GSK. Paravertebral Dexmedetomidine in Video-Assisted Thoracic Surgeries for Acute and Chronic Pain Prevention. Pain Physician. 2019 May;22(3):271-280.
PubMed 31151335Zhang X, Zhang C, Zhou X, Chen W, Li J, Wang H, Liu J. Analgesic Effectiveness of Perioperative Ultrasound-Guided Serratus Anterior Plane Block Combined with General Anesthesia in Patients Undergoing Video-Assisted Thoracoscopic Surgery: A Systematic Review and Meta-analysis. Pain Med. 2020 Oct 1;21(10):2412-2422. doi: 10.1093/pm/pnaa125.
PubMed 32488265Thangavel AR, Sethi S, Gupta V. Comparison of Continuous Wound Infusion versus Continuous Epidural Infusion in Upper Abdominal Surgery: Noninferiority Randomized Controlled Trial. Anesth Essays Res. 2019 Oct-Dec;13(4):676-682. doi: 10.4103/aer.AER_133_19. Epub 2019 Dec 16.
PubMed 32009714Fusco P, Cofini V, Petrucci E, Scimia P, Fiorenzi M, Paladini G, Behr AU, Borghi B, Flamini S, Pizzoferrato R, Colafarina O, Di Francesco A, Tabacco T, Necozione S, Marinangeli F. Continuous wound infusion and local infiltration analgesia for postoperative pain and rehabilitation after total hip arthroplasty. Minerva Anestesiol. 2018 May;84(5):556-564. doi: 10.23736/S0375-9393.17.12110-3. Epub 2017 Oct 4.
PubMed 28984095