- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07746323
Effect of Modified Arm Positioning on Shoulder Pain After Thoracoscopic Lobectomy
Effect of Modified Bilateral Arm Wrapping Position on Postoperative Ipsilateral Shoulder Pain in Patients Undergoing Video-Assisted Thoracoscopic Lobectomy: A Prospective Randomized Controlled Trial
This study is a prospective randomized controlled trial aiming to reduce shoulder pain after lung surgery. Shoulder pain on the surgical side is common after video-assisted thoracoscopic lobectomy, affecting about 20%-58% of patients. It can limit coughing, moving, and sleeping, and may delay recovery.
The pain may come from two sources: nerve stimulation during surgery and the prolonged arm position used during the operation. While nerve stimulation is hard to avoid, the arm position can be modified. Currently, most pain treatments rely on medications or nerve blocks given after surgery, which have side effects or risks. No one has tried to prevent the pain by changing the arm position during the operation.
We plan to enroll 270 patients scheduled for thoracoscopic lung removal surgery at Chengdu Shangjin Nanfu Hospital. Patients will be randomly divided into two groups. One group will receive the standard side-lying position with arms extended on arm boards (traditional position). The other group will receive a modified position where both arms are bent at the elbows and wrapped with surgical drapes, without using arm boards (modified double-arm wrap position).
Our main goal is to compare the rate of shoulder pain (on the operated side) within 24 hours after surgery between the two groups. We will also compare pain on the opposite shoulder, pain severity, time needed to set up the position, total surgery time, hospital stay, and any nerve or skin complications.
This study has been approved by the Biomedical Ethics Review Committee of West China Hospital, Sichuan University. All participants will provide written informed consent. The findings may help improve intraoperative positioning and enhance early recovery after lung surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: LU FENG
- Phone Number: +86 15982012545
- Email: fengluhx@163.com
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610011
- Recruiting
- Chengdu Shangjin Nanfu Hospita
-
Contact:
- Lu Lu
- Phone Number: 18981859640
- Email: jiafeijjfy@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18 years.
- Diagnosed with pulmonary space-occupying lesion and scheduled for elective video-assisted thoracoscopic standard lobectomy.
- ASA physical status classification I-III.
- No pre-existing shoulder pain or shoulder mobility impairment prior to surgery.
- No long-term use of analgesic medications (>1 week) before surgery.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Severe cervical spine disease or history of brachial plexus injury.
- Cognitive impairment or psychiatric disorder precluding understanding of pain assessment scales.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional Arm-Board Position
|
Participants in this arm are placed in the standard lateral decubitus position with a thin pillow under the lower side.
The contralateral upper arm is abducted to slightly less than 90 degrees with the elbow extended, and the forearm is placed on an arm board with a strap secured at the elbow.
The ipsilateral arm is similarly positioned on a separate arm board.
Both arm boards are used for fixation throughout the entire surgical procedure.
|
|
Experimental: Modified Bilateral Arm-Wrapping Position
|
Participants in this arm are placed in the standard lateral decubitus position with a thin pillow under the lower side.
Both upper arms are abducted to slightly less than 90 degrees, with elbows flexed at 90 degrees.
A soft pad is placed between the hands.
The forearms are positioned forward above the head, and both arms are wrapped together with surgical drapes for secure fixation.
No arm boards are used.
This modified position is maintained throughout the entire surgical procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of Ipsilateral Shoulder Pain Within 24 Hours Postoperatively
Time Frame: Within the first 24 hours after surgery
|
Within the first 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of Contralateral Shoulder Pain Within 24 Hours Postoperatively
Time Frame: Within the first 24 hours after surgery (Postoperative Day 1, 0-24 hours)
|
Within the first 24 hours after surgery (Postoperative Day 1, 0-24 hours)
|
|
VAS scores for Ipsilateral Shoulder Pain at rest and on movement at 24 h postoperatively.
Time Frame: At 24 hours postoperatively
|
At 24 hours postoperatively
|
|
incidence of ipsilateral shoulder pain at postoperative day 3
Time Frame: Postoperative Day 3
|
Postoperative Day 3
|
|
Positioning Setup Time
Time Frame: Intraoperative recording
|
Intraoperative recording
|
|
Total Surgical Duration
Time Frame: Intraoperative recording
|
Intraoperative recording
|
|
Postoperative Hospital Stay
Time Frame: At hospital discharge
|
At hospital discharge
|
|
Incidence of Brachial Plexus Injury-Related Signs Within 72 Hours Postoperatively
Time Frame: Within 72 hours postoperatively
|
Within 72 hours postoperatively
|
|
Position-related pressure injury within 72 h
Time Frame: From the end of surgery to 72 hours postoperatively
|
From the end of surgery to 72 hours postoperatively
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025(693)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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