Physical Stabilization in Post-VATS

• Sponsor: National Taiwan University Hospital Hsin-Chu Branch (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04735614
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.1
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

Background: Post-video-assisted thoracic surgery (VATS) pain remains an open issue, though most patients experience less acute pain after VATS than thoracotomy. So far, there was no gold standard regarding pain control post-VATS.

Objective: To conduct a randomized controlled trial assessing the effect of physical thoracic stabilization on post-VATS pain control.

Method: The investigators aimed to recruit 40 patients with operable lung cancer in the outpatient clinic from January to December 2021. The patients will be randomized into the intervention or control group. The intervention group will receive physical thoracic stabilization with POSTHORAX ThoraxBelt after the surgery, whereas the control group will have standard care. The follow-up period will last for 6 months.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Pain, Postoperative	Device: Posthorax Thoraxbelt	N/A

Detailed Description

The study has been approved by the hospital research ethics committee.

Arm 1: Physical thoracic stabilization with ThoraxBelt after VATS Arm 2: Standard care after VATS

Primary outcome: Visual analog scale (VAS) 6 hours, 24 hours, and 48 hours after the surgery.

Secondary outcomes:

1. The accumulated dose of the intervenous patient-controlled analgesic drug.

2. The dose of oral painkiller administered during the hospital stay.

3. Complications related to the ThoraxBelt.

4. Hospital stay

5. VAS before discharge

6. Unanticipated events (ICU admission, a second surgery, death)

7. VAS during the 2-week, 1-month, 2-month, 6-month outpatient clinic visit after the surgery.

8. Compliance on ThoraxBelt.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Masking Description: The surgeon will not know the patients' group before or during the surgery. The outcome assessor won't know the group during the whole research.
• Primary Purpose: Prevention
• Official Title: The Effect of Physical Thoracic Stabilization on Pain Control in Patients Who Had a Lung Tumor and Received Video-assisted Thoracoscopic Surgery: A Randomized Controlled Trial.
• Actual Study Start Date: Jan 27, 2021
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ThoraxBelt Received ThoraxBelt after the surgery. Standard care for pain management will be the same as the Standard Care Arm.	Device: Posthorax Thoraxbelt; The patients will be assisted to put on the ThoraxBelt after the surgery by our research member and will be asked to keep it on except for during showering through the whole study period.
No Intervention: Standard care Standard care with IV PCA and on-request oral painkiller.

Outcome Measures

Primary Outcome Measures

1. Visual analog scale(VAS) [48 hours]

   A pain score will be assigned to each patient after the total amount of visual analog scale. The minimum is 0 and the maximum is 10, which 10 indicated the most pain.

Secondary Outcome Measures

1. IV PCA dose [48 hours]

   the accumulated IV PCA drug dose

2. On-request oral painkiller dose [48 hours]

   the accumulated oral painkiller dose

3. Complications during hospital stay [48 hours]

   Any complications related to ThoraxBelt or not

4. Length of hospital stay [1 month]

   The number of days in the hospital stay.

5. The number of unanticipated events [1 month]

   The number of unanticipated events including ICU admission, a second surgery or death will be documented in both groups.

6. Visual analog scale in outpatient clinic follow-up [6 months]

   follow-up 2-week, 1-month, and 6-month after discharge. The minimum is 0 and the maximum is 10, which 10 indicated the most pain.

7. Compliance of ThoraxBelt after discharge [2 months]

   How long is the ThoraxBelt removed except during bath in a day. The unit is hour.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Operable lung cancer

• Eligible for video-assisted thoracoscopic surgery

Exclusion Criteria:

• Known allergy to ThoraxBelt

• Chest wall Infection or other diseases

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital Hsin-Chu Branch	Hsinchu		Taiwan	300

Sponsors and Collaborators

• National Taiwan University Hospital Hsin-Chu Branch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital Hsin-Chu Branch
• ClinicalTrials.gov Identifier: NCT04735614
• Other Study ID Numbers: 109-118-F
• First Posted: Feb 3, 2021
• Last Update Posted: Apr 12, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Taiwan University Hospital Hsin-Chu Branch: video-assisted thoracoscopic surgery; VATS; post-operation pain control; patient-controlled analgesia; visual analogue scale; Posthorax Thoraxbelt
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Apr 12, 2021