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

NCT06210958 | Completed DMC

• 1 other identifier: ANE-2566-0137
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Intertransverse Process Block; Video Assisted Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  24 hour after intervention

Study Arms (2)

S-group

EXPERIMENTAL

Single injection of ITPB at T4-5 level

Other: Intertransverse process block

T-group

EXPERIMENTAL

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

Other: Intertransverse process block

Interventions

Intertransverse process block OTHER

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

S-group; T-group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• \. 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.

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Department of Anesthesiology

Chiang Mai, Chiang Mai, 50200, Thailand

Location

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Study Officials

• Kittitorn Supphapipat

  Department of Anesthesiology, Faculty of Medicaine, Chaing Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-investigator, Department of Anesthesiology

Model Details: The patients will be divided into 2 groups: single injection of intertransverse process block and triple injection of intertransverse process block

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 18, 2024
• Study Start: January 25, 2024
• Primary Completion: October 31, 2024
• Study Completion: November 1, 2024
• Last Updated: February 19, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)