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

January 8, 2024 updated by: Kittitorn Supphapipat, Chiang Mai University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-group
The patients will be received the single injection of ITPB at T5-6 level
Other: Intertransverse process block
The patients will be randomized into 2 groups which will receive the different techniques of the intertransverse process block
Experimental: T-group
The patients will be received the triple injection of ITPB at T4-5, 5-6, 6-7 levels
Other: Intertransverse process block
The patients will be randomized into 2 groups which will receive the different techniques of the intertransverse process block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: at 1 hour after the end of surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 24 hour after surgery
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
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
Time Frame: 24 hour after surgery
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
Time Frame: 24 hour after intervention
24 hour after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ANE-2566-0137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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