Intertransverse Process BlockNCT06210958
Single- vs. Triple-Injection Techniques for Intertransverse Process Blocks in Video-Assisted Thoracoscopic Surgery: A Randomized Trial on Sensory Blockade
A study testing Intertransverse process block in people with Intertransverse Process Block and Video Assisted Thoracic Surgery, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The intertransverse process block (ITPB) is an alternatives technique of regional anesthesia for thoracic surgery. However, the precise technique of ITPB remains developing. This study aims to evaluate the efficacy of ITPB injections which are single and triple injection in adult-patients undergoing video-assisted… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Intertransverse Process Block, Video Assisted Thoracic Surgery
- What is being tested?
- Intertransverse process block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 25 Jan 2024to 1 Nov 2024
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20-70 years old
- Undergoing scheduled the first time for each side of video-assisted thoracoscopic surgery (VATS) for pulmonary resection
- American Society of Anesthesia (ASA) physical status I-III
- Patients have ability to communicate and understand the study and accept to participate in study
- Body weight >40 kg
Who cannot join
- Patients who allergic to bupivacaine, lidocaine, NSAIDS, paracetamol, and dexamethasone
- Patients who have following underlying disease: renal impairment (diagnosed of end-stage renal disease (ESRD) or chronic kidney disease (CKD) which estimated glomerular filtration rate (eGFR) < 60 ml/min per 1.73 square meters) , hepatic impairment (diagnosed of cirrhosis or evidence of abnormal liver function test which are increased liver enzymes or bilirubin level), coagulopathy (diagnosed of disease associated with abnormal coagulation, currently use any anticoagulants or evidence of prolong prothrombin time (PT) or partial thromboplastin time (PTT)), thrombocytopenia (platelet count less than 150,000/microliter), platelet disfunction from any causes such as current use antiplatelet or uremia (BUN level > 60 mg/dL) , morbid obesity (BMI >40 kg/m2), pre-existing neurological deficits, chronic pain (diagnosed of chronic pain disease or current use regular analgesic drugs), or any drug addiction • Withdrawal criteria: a participant will be withdrawn from the study in case of
- 1. Procedural failure: the operator cannot place the needle tip in the intertransverse tissue according to the technical difficulty or abnormal anatomy after 15 minutes of performing the block (from the beginning of needle insertion to the injection of local anesthetic) 2. Anesthetic related events including cardiac arrest, difficult intubation 3. Surgical related events including massive bleeding, major organ injury, converted operation to open thoracotomy and reoperation within admission 4. Participant related reasons including patient's willing to withdraw from the study or failure to adhere adequately to protocol requirements such as premature discharge. However, the withdrawn participant will be continued follow up of clinical outcome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of Cutaneous Sensory Blockade Between Ultrasound Guided Single and Triple Injections of Intertransverse Process Block in Patients Undergoing Video Assisted Thoracoscopic Surgery
The intertransverse process block (ITPB) is an alternatives technique of regional anesthesia for thoracic surgery. However, the precise technique of ITPB remains developing. This study aims to evaluate the efficacy of ITPB injections which are single and triple injection in adult-patients undergoing video-assisted thoracoscopic surgery. The investigators hypothesize that cutaneous sensory block and perioperative pain outcomes including pain intensity and opioids consumption in patients who received triple injections of ITPB are better than that of single injection.
Read the detailed description
Objectives: evaluate the efficacy of single and triple injections of ultrasound-guided ITPB in adult patients undergoing video-assisted thoracoscopic surgery for pulmonary resection Setting: Single center tertiary teaching hospital Participants: adult-patients who undergoing scheduled video-assisted thoracoscopic surgery for pulmonary resection.
Intervention: The patient will divide to 2 groups of intervention: single injection of ITPB (S-group) and triple injection of ITPB (T-group). The ITPB will be perform after routine general anesthesia. The primary outcomes is to compare the distribution of cutaneous block after single and triple injections of ultrasound-guided ITPB in adult patients undergoing video-assisted thoracoscopic surgery for pulmonary resection. The distribution of cutaneous block will be evaluate at PACU.
- Being tested
- Intertransverse process block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intertransverse process blockOther
The patients will be randomized into 2 groups which will receive the different techniques of the intertransverse process block
| Study group | Role | What they receive |
|---|---|---|
| S-group | Experimental | Single injection of ITPB at T4-5 level Receives: Other: Intertransverse process block |
| T-group | Experimental | Triple injection of ITPB at T3-4, T4-5, T5-6 levels Receives: Other: Intertransverse process block |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the distribution of cutaneous block after the inter transverse process block and triple injections of ultrasound-guided ITPB in adult patients undergoing video-assisted thoracoscopic surgery for lobectomy
the distribution of cutaneous block is the cutaneous sensory distribution of dermatomes involvement by the intertransverse process block. A cutaneous sensory distribution is defined as an area of reduced sensitivity to cold touch as compare to the abdomen which participants know as 'normal'. The assessment begins at the mid-clavicular line on the block side, processing laterally to the posterior axillary line on the chest wall and apex of axilla (between T2-T10 dermatomes) at about 1-cm intervals, bilaterally.
Measured: at 1 hour after the end of surgery
Secondary outcomes (3)
To compare pain intensity using numerical rating scale during the first 24-hours postoperative period after single and triple injections of ultrasound-guided ITPB in adult patients undergoing video-assisted thoracoscopic surgery for lobectomy
The numerical rating scale is a pain scales using numbers from 0 to 10. A score of 0 means no pain, and 10 means the worst pain.
Measured: 24 hour after surgery
To compare opioids consumption during the intraoperative and the first 24-hours postoperative period after single and triple injections of ultrasound-guided ITPB in adult patients undergoing video-assisted thoracoscopic surgery for lobectomy
Measured: 24 hour after surgery
To compare adverse complication (pneumothorax, hemothorax) after single and triple injections of ultrasound-guided ITPB in adult patients undergoing video-assisted thoracoscopic surgery for lobectomy
Measured: 24 hour after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start25 Jan 2024
- Primary completion31 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Intertransverse Process BlockStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be divided into 2 groups: single injection of intertransverse process block and triple injection of intertransverse process block
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kittitorn Supphapipat, MD, Chiang Mai University
- Investigators
- Kittitorn Supphapipat, Principal investigator, Department of Anesthesiology, Faculty of Medicaine, Chaing Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210958
- Sponsor's protocol ID
- ANE-2566-0137
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared
Publications
Bade BC, Dela Cruz CS. Lung Cancer 2020: Epidemiology, Etiology, and Prevention. Clin Chest Med. 2020 Mar;41(1):1-24. doi: 10.1016/j.ccm.2019.10.001.
PubMed 32008623Sihoe ADL. Video-assisted thoracoscopic surgery as the gold standard for lung cancer surgery. Respirology. 2020 Nov;25 Suppl 2:49-60. doi: 10.1111/resp.13920. Epub 2020 Jul 30.
PubMed 32734596Jones GS, Baldwin DR. Recent advances in the management of lung cancer. Clin Med (Lond). 2018 Apr 1;18(Suppl 2):s41-s46. doi: 10.7861/clinmedicine.18-2-s41.
PubMed 29700092Marshall K, McLaughlin K. Pain Management in Thoracic Surgery. Thorac Surg Clin. 2020 Aug;30(3):339-346. doi: 10.1016/j.thorsurg.2020.03.001. Epub 2020 Apr 29.
PubMed 32593366Tong Y, Wei P, Wang S, Sun Q, Cui Y, Ning N, Chen S, He X. Characteristics of Postoperative Pain After VATS and Pain-Related Factors: The Experience in National Cancer Center of China. J Pain Res. 2020 Jul 21;13:1861-1867. doi: 10.2147/JPR.S249134. eCollection 2020.
PubMed 32765060Takenaka S, Saeki A, Sukenaga N, Ueki R, Kariya N, Tatara T, Hirose M. Acute and chronic neuropathic pain profiles after video-assisted thoracic surgery: A prospective study. Medicine (Baltimore). 2020 Mar;99(13):e19629. doi: 10.1097/MD.0000000000019629.
PubMed 32221089Zhang Y, Zhou R, Hou B, Tang S, Hao J, Gu X, Ma Z, Zhang J. Incidence and risk factors for chronic postsurgical pain following video-assisted thoracoscopic surgery: a retrospective study. BMC Surg. 2022 Mar 2;22(1):76. doi: 10.1186/s12893-022-01522-1.
PubMed 35236334Peng J, Wang Z, Ma L, Ma W, Liu G, Zhang H, Wang Q, Zhu B, Zhao L. Incidence and Influencing Factors of Chronic Postthoracotomy Pain in Lung Tumor Patients. J Healthc Eng. 2022 Feb 24;2022:7584481. doi: 10.1155/2022/7584481. eCollection 2022.
PubMed 35251576Piccioni F, Ragazzi R. Anesthesia and analgesia: how does the role of anesthetists changes in the ERAS program for VATS lobectomy. J Vis Surg. 2018 Jan 11;4:9. doi: 10.21037/jovs.2017.12.11. eCollection 2018.
PubMed 29445595Bugada D, Lorini LF, Lavand'homme P. Opioid free anesthesia: evidence for short and long-term outcome. Minerva Anestesiol. 2021 Feb;87(2):230-237. doi: 10.23736/S0375-9393.20.14515-2. Epub 2020 Aug 4.
PubMed 32755088Nafziger AN, Barkin RL. Opioid Therapy in Acute and Chronic Pain. J Clin Pharmacol. 2018 Sep;58(9):1111-1122. doi: 10.1002/jcph.1276. Epub 2018 Jul 9.
PubMed 29985526Olausson A, Svensson CJ, Andrell P, Jildenstal P, Thorn SE, Wolf A. Total opioid-free general anaesthesia can improve postoperative outcomes after surgery, without evidence of adverse effects on patient safety and pain management: A systematic review and meta-analysis. Acta Anaesthesiol Scand. 2022 Feb;66(2):170-185. doi: 10.1111/aas.13994. Epub 2021 Nov 11.
PubMed 34724195Feray 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 34739134Lin J, Liao Y, Gong C, Yu L, Gao F, Yu J, Chen J, Chen X, Zheng T, Zheng X. Regional Analgesia in Video-Assisted Thoracic Surgery: A Bayesian Network Meta-Analysis. Front Med (Lausanne). 2022 Apr 6;9:842332. doi: 10.3389/fmed.2022.842332. eCollection 2022.
PubMed 35463038Richardson J, Lonnqvist PA. Thoracic paravertebral block. Br J Anaesth. 1998 Aug;81(2):230-8. doi: 10.1093/bja/81.2.230. No abstract available.
PubMed 9813528