- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05901129
The Efficacy of SPSIPB on Postoperative Pain in Patients Undergoing Shoulder Surgery
June 5, 2024 updated by: Oguz Gundogdu, Cumhuriyet University
The Efficacy of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Shoulder Surgery
Aim is to assess the postoperative analgesic efficacy of SPSIPB and its effect on opioid consumption in patients undergoing shoulder surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There were three randomized groups: Group 1 (no block-control group, n=12) Group 2 (SPSIPB-2nd rib targetted, n=12), Group 3 (SPSIPB-3rd rib targetted, n=12).
All patients had standard general anesthesia.
Group 2 and Group 3 had serratus posterior superior intercostal plane block (SPSIPB) with 0.25% bupivacaine (total volume of 30 ml) before the surgery.
Local anesthetic was injected between 2nd rib an serratus posterior superior muscle in Group 2 and it was injected between 3rd rib and same muscle in Group 3. All patients had 50 mg dexketoprofen and 1 gr paracetamol intravenos (i.v.) 10 minutes prior to skin closure.
All patients had ibuprofen 3x400 mg in postoperative 24 hours.
Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery.
50 mg tramadol was administered as a rescue analgesic in all patients.Total tramadol consumption was calculated.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sivas, Turkey, 58000
- Sivas Cumhuriyet University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult patients older than 18 years of age who underwent open or arthroscopic shoulder surgery under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
Exclusion Criteria:
- Patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
- patients with unstable hemodynamics,
- patients who could not cooperate during postoperative pain assessment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SPSIPB
SPSIP block is the intervention used in this study.
It was performed when the patient is in lateral decubitis position.
A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized.
The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles.
After contact of the needle with the rib gently, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle.
All patients had 3x400 mg ibuprofen intravenous (i.v.) in postoperative 24 hours.
50 mg tramadol was given as a rescue analgesic drug to the patients who had numerical rating scale (NRS) 4 or higher.
|
Serratus posterior superior intercostal plane block is the intervention used in this study.
It was performed when the patient is in lateral decubitis position.
A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized.
The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles.
After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle.
|
No Intervention: Control
Control group patients were not subjected to any block or local infiltration anesthesia (local anesthetic administration around the incision).
Their postoperative pain was relieved with ibuprofen 3x400mg intravenous (i.v.) in postoperative 24 hours.
The patients had NRS score 4 or higher were given 50 mg tramadol as a rescue analgesic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical rating scale (NRS) scores
Time Frame: Postoperative 24 hours
|
Numerical rating scale is used for pain assessment.
The scores of the numerical rating scale changes between 0 to 10 points.
10 points mean "the most severe pain that the patient ever had".
0 point means "there is no pain."
Higher scores mean worse outcome.
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Postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total tramadol consumption
Time Frame: Postoperative 24 hours
|
Postoperative total analgesic need was recorded as "milligram" in unit.
|
Postoperative 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Oğuz Gündoğdu, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 29, 2023
Primary Completion (Actual)
May 25, 2023
Study Completion (Actual)
June 1, 2023
Study Registration Dates
First Submitted
June 1, 2023
First Submitted That Met QC Criteria
June 12, 2023
First Posted (Actual)
June 13, 2023
Study Record Updates
Last Update Posted (Actual)
June 6, 2024
Last Update Submitted That Met QC Criteria
June 5, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPSIPB on shoulder surgery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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