NCT07746323

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
May 2026Sep 2026

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

August 5, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 22, 2026

Last Update Submit

July 31, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of Ipsilateral Shoulder Pain Within 24 Hours Postoperatively

    Within the first 24 hours after surgery

Secondary Outcomes (8)

  • Incidence of Contralateral Shoulder Pain Within 24 Hours Postoperatively

    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.

    At 24 hours postoperatively

  • incidence of ipsilateral shoulder pain at postoperative day 3

    Postoperative Day 3

  • Positioning Setup Time

    Intraoperative recording

  • Total Surgical Duration

    Intraoperative recording

  • +3 more secondary outcomes

Study Arms (2)

Traditional Arm-Board Position

ACTIVE COMPARATOR
Other: Traditional Arm-Board Position

Modified Bilateral Arm-Wrapping Position

EXPERIMENTAL
Other: Modified Double-Arm Wrap Positioning

Interventions

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.

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. 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.

Traditional Arm-Board Position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Severe cervical spine disease or history of brachial plexus injury.
  • Cognitive impairment or psychiatric disorder precluding understanding of pain assessment scales.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chengdu Shangjin Nanfu Hospita

Chengdu, Sichuan, 610011, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Anesthesiology Department

Study Record Dates

First Submitted

July 22, 2026

First Posted

August 5, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

August 5, 2026

Record last verified: 2026-07

Locations