Percutaneous Peripheral Nerve Stimulation (PPNS) for Post-Surgical Pain After Shoulder Surgery
STIM-SHOULDER
2 other identifiers
interventional
60
0 countries
N/A
Brief Summary
Despite the implementation of Enhanced Recovery After Surgery (ERAS) protocols incorporating multimodal analgesia and regional anesthesia, postoperative pain following shoulder surgery remains inadequately controlled. Percutaneous peripheral nerve stimulation (PPNS) represents a potential alternative strategy for postoperative pain management. This prospective randomized study aims to assess the efficacy of PPNS for postoperative pain control following shoulder surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2026
CompletedFirst Posted
Study publicly available on registry
March 30, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
March 30, 2026
March 1, 2026
2.4 years
March 17, 2026
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative morphine consumption at 48 hours after surgery
The cumulative morphine sulfate consumption from the operating room discharge to 48 hours after surgery
From operating room discharge to 48 hours postoperatively
Secondary Outcomes (8)
Time required for catheter placement
Before the surgery (day 0)
Pain intensity during regional anaesthesia placement
Before the surgery (day 0)
Postoperative pain intensity
From admission to the Post-Anesthesia Care Unit (PACU) to 72 hours postoperatively
Diaphragmatic excursion assessed by ultrasound
From operating room discharge to 24 hours postoperatively
Sniff nasal inspiratory pressure (SNIP)
From operating room discharge to 24 hours postoperatively
- +3 more secondary outcomes
Study Arms (2)
Neurostimulation Group
EXPERIMENTALThe catheter will be placed preoperatively and used to perform the interscalene block. Postoperative peripheral nerve stimulation therapy will be initiated in case of pain. Stimulation sessions of approximately 20 minutes will be delivered, with parameters adjusted according to the patient's perception within a patient-centered neuromodulation approach. Stimulation settings may be modified by the physician (20-100 Hz, pulse width 0.1 ms, intensity 0.1-0.5 mA), with a maximum of three sessions per day. If this strategy fails to provide adequate analgesia, rescue analgesia will be administered.
Control Group
ACTIVE COMPARATORPatients in the control group will receive preoperative regional anesthesia to perform an interscalene block. In case of postoperative pain, patients will receive rescue analgesia.
Interventions
The catheter will be placed preoperatively and used to perform the interscalene block. Postoperative peripheral nerve stimulation therapy will be initiated in case of pain. Stimulation sessions of approximately 20 minutes will be delivered, with parameters adjusted according to the patient's perception within a patient-centered neuromodulation approach. Stimulation settings may be modified by the physician (20-100 Hz, pulse width 0.1 ms, intensity 0.1-0.5 mA), with a maximum of three sessions per day. If this strategy fails to provide adequate analgesia, rescue analgesia will be administered.
Active Comparator: Control Group Arm Description: Patients in the control group will receive preoperative regional anesthesia to perform an interscalene block. In case of postoperative pain, patients will receive rescue analgesia.
Eligibility Criteria
You may qualify if:
- Patients aged over 18 years old
- Patients scheduled for shoulder surgery under regional and general anesthesia
You may not qualify if:
- Outpatient surgery
- Patients scheduled for magnetic resonance imaging (MRI)
- Patients with an implanted pacemaker
- Patients receiving chronic opioid therapy
- Opioid mesusage
- Contraindication to general anesthesia
- Contraindication to regional anesthesia
- Contraindication to analgesics (morphine sulfate, nonsteroidal anti-inflammatory drugs or acetaminophen)
- Any contraindication listed in the instructions for use of the investigational medical device
- Inability to complete a self-assessment questionnaire
- Inability to ensure follow-up for 72 hours postoperatively
- Lack of written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2026
First Posted
March 30, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share