A Comparison of Cutaneous Sensory Blockade Between Single and Triple Injection of Intertransverse Process Block in Video Assisted Thoracoscopic Surgery Guided Single and Triple Injections of Intertransverse Process Block in Patients Undergoing Video Assisted Thoracoscopic Surgery

Video Assisted Thoracic Surgery Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06210958
• Other study ID #: ANE-2566-0137
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: January 2024
• Source: Chiang Mai University
• Contact: Kittitorn Supphapipat
• Phone: 0891920066
• Email: kittitorn.pans[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Description:

Objectives: evaluate the efficacy of single and triple injections of ultrasound-guided ITPB in adult patients undergoing video-assisted thoracoscopic surgery for lobectomy Setting: Single center tertiary teaching hospital Participants: adult-patients who undergoing scheduled video-assisted thoracoscopic surgery for lobectomy.

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 before 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 lobectomy. The distribution of cutaneous block will be evaluate at PACU.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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 lobectomy

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.

Related Conditions & MeSH terms

• Video Assisted Thoracic Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

References & Publications (20)

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 midline of the posterior thorax at level of the block then move laterally (left and right side), cranially and caudally (between T2-T10 dermatomes) at about 1-cm intervals.	at 1 hour after the end of surgery
Secondary	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.	24 hour after surgery
Secondary	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
Secondary	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