Single- Vs. Triple-Injection Techniques for Intertransverse Process Blocks in Video-Assisted Thoracoscopic Surgery: a Randomized Trial on Sensory Blockade

NCT ID: NCT06210958

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-25

Study Completion Date

2024-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intertransverse Process Block Video Assisted Thoracic Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients will be divided into 2 groups: single injection of intertransverse process block and triple injection of intertransverse process block
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

S-group

Single injection of ITPB at T4-5 level

Group Type EXPERIMENTAL

Intertransverse process block

Intervention Type OTHER

The patients will be randomized into 2 groups which will receive the different techniques of the intertransverse process block

T-group

Triple injection of ITPB at T3-4, T4-5, T5-6 levels

Group Type EXPERIMENTAL

Intertransverse process block

Intervention Type OTHER

The patients will be randomized into 2 groups which will receive the different techniques of the intertransverse process block

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intertransverse process block

The patients will be randomized into 2 groups which will receive the different techniques of the intertransverse process block

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients aged 20-70 years old
2. Undergoing scheduled the first time for each side of video-assisted thoracoscopic surgery (VATS) for pulmonary resection
3. American Society of Anesthesia (ASA) physical status I-III
4. Patients have ability to communicate and understand the study and accept to participate in study
5. Body weight \>40 kg

Exclusion Criteria

1. Patients who allergic to bupivacaine, lidocaine, NSAIDS, paracetamol, and dexamethasone
2. 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kittitorn Supphapipat

Co-investigator, Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kittitorn Supphapipat

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Faculty of Medicaine, Chaing Mai University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Anesthesiology

Chiang Mai, Chiang Mai, Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32008623 (View on PubMed)

Sihoe 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.

Reference Type BACKGROUND
PMID: 32734596 (View on PubMed)

Jones 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.

Reference Type BACKGROUND
PMID: 29700092 (View on PubMed)

Marshall 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.

Reference Type BACKGROUND
PMID: 32593366 (View on PubMed)

Tong 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.

Reference Type BACKGROUND
PMID: 32765060 (View on PubMed)

Takenaka 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.

Reference Type BACKGROUND
PMID: 32221089 (View on PubMed)

Zhang 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.

Reference Type BACKGROUND
PMID: 35236334 (View on PubMed)

Peng 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.

Reference Type BACKGROUND
PMID: 35251576 (View on PubMed)

Piccioni 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.

Reference Type BACKGROUND
PMID: 29445595 (View on PubMed)

Bugada 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.

Reference Type BACKGROUND
PMID: 32755088 (View on PubMed)

Nafziger 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.

Reference Type BACKGROUND
PMID: 29985526 (View on PubMed)

Olausson 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.

Reference Type BACKGROUND
PMID: 34724195 (View on PubMed)

Feray 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.

Reference Type BACKGROUND
PMID: 34739134 (View on PubMed)

Lin 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.

Reference Type BACKGROUND
PMID: 35463038 (View on PubMed)

Richardson 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.

Reference Type BACKGROUND
PMID: 9813528 (View on PubMed)

Sharma R, Louie A, Thai CP, Dizdarevic A. Chest Wall Nerve Blocks for Cardiothoracic, Breast Surgery, and Rib-Related Pain. Curr Pain Headache Rep. 2022 Jan;26(1):43-56. doi: 10.1007/s11916-022-01001-5. Epub 2022 Jan 28.

Reference Type BACKGROUND
PMID: 35089532 (View on PubMed)

Kim SH. Anatomical classification and clinical application of thoracic paraspinal blocks. Korean J Anesthesiol. 2022 Aug;75(4):295-306. doi: 10.4097/kja.22138. Epub 2022 Apr 4.

Reference Type BACKGROUND
PMID: 35368174 (View on PubMed)

Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.

Reference Type BACKGROUND
PMID: 26897642 (View on PubMed)

Junior Ade P, Erdmann TR, Santos TV, Brunharo GM, Filho CT, Losso MJ, Filho GR. Comparison between continuous thoracic epidural and paravertebral blocks for postoperative analgesia in patients undergoing thoracotomy: Systematic review. Braz J Anesthesiol. 2013 Sep-Oct;63(5):433-42. doi: 10.1016/j.bjane.2013.10.002. Epub 2013 Nov 19.

Reference Type BACKGROUND
PMID: 24565302 (View on PubMed)

Cho TH, Kwon HJ, O J, Cho J, Kim SH, Yang HM. The pathway of injectate spread during thoracic intertransverse process (ITP) block: Micro-computed tomography findings and anatomical evaluations. J Clin Anesth. 2022 May;77:110646. doi: 10.1016/j.jclinane.2022.110646. Epub 2022 Jan 10.

Reference Type BACKGROUND
PMID: 35021139 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ANE-2566-0137

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.