Effect of Modified Arm Positioning on Shoulder Pain After Thoracoscopic Lobectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChengdu Jinjiang Maternity and Child Health Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Severe cervical spine disease or history of brachial plexus injury.
Cognitive impairment or psychiatric disorder precluding understanding of pain assessment scales.
Trial design
Design model
Parallel
Treatments tested in this trial
Modified Double-Arm Wrap Positioning
Other interventionParticipants 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.
Traditional Arm-Board Position
Other interventionParticipants 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.
Treatment groups
270 Participants
are divided into 2 treatment groupsGroup A: Traditional Arm-Board PositionActive comparator 1 intervention
Group B: Modified Bilateral Arm-Wrapping PositionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Ipsilateral Shoulder Pain Within 24 Hours Postoperatively
Time frame
Within the first 24 hours after surgerySecondary outcomes
1
Incidence of Contralateral Shoulder Pain Within 24 Hours Postoperatively
Time frame
Within the first 24 hours after surgery (Postoperative Day 1, 0-24 hours)2
VAS scores for Ipsilateral Shoulder Pain at rest and on movement at 24 h postoperatively.
Time frame
At 24 hours postoperatively3
incidence of ipsilateral shoulder pain at postoperative day 3
Time frame
Postoperative Day 34
Positioning Setup Time
Time frame
Intraoperative recordingSponsors and contacts
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Source ClinicalTrials.gov