Postoperative Pain, Hemidiaphragmatic Paresis
Conditions
Keywords
Shoulder Arthroscopy, Postoperative Analgesia, Suprascapular Nerve Block, PECS I Block, Interscalene Brachial Plexus Block, Hemidiaphragmatic Paresis, Diaphragmatic Excursion, Ultrasound-Guided Regional Anesthesia, Tramadol Consumption, Non-Inferiority Trial
Brief summary
Shoulder arthroscopy can cause moderate to severe pain after surgery. An interscalene block is commonly used to reduce this pain, but it may temporarily weaken movement of the diaphragm on the treated side. This study will compare an interscalene block with a combination of suprascapular nerve block and PECS I block in adults undergoing elective shoulder arthroscopy. The researchers want to determine whether the combined blocks provide pain relief that is not meaningfully worse than the interscalene block while causing less impairment of diaphragm movement. A total of 80 participants will be randomly assigned to one of two groups. All participants will receive general anesthesia. At the end of surgery, while participants are still under anesthesia, one group will receive the combined suprascapular nerve and PECS I blocks, and the other group will receive an interscalene block. Both groups will use the same intravenous patient-controlled pain pump containing tramadol after surgery. The main outcome will be the total amount of tramadol used during the first 24 hours after surgery. The study will also assess pain scores, diaphragm movement measured by ultrasound, quality of recovery, time until additional pain medicine is first needed, nausea and vomiting, anti-nausea medicine use, and block-related side effects during the first 24 hours.
Detailed description
Interscalene brachial plexus block provides effective analgesia after shoulder surgery but is associated with ipsilateral phrenic nerve blockade and hemidiaphragmatic dysfunction. These effects may limit its use, particularly in patients with reduced respiratory reserve. The combination of suprascapular nerve block and PECS I block may provide broader coverage of the sensory innervation of the shoulder while reducing the risk of phrenic nerve involvement. This prospective, single-center, randomized, single-blind, parallel-group, active-controlled non-inferiority trial will include 80 adults aged 18 to 75 years with American Society of Anesthesiologists physical status I to III who are scheduled for elective arthroscopic shoulder surgery. Participants will be randomly allocated in a 1:1 ratio to the combined-block group or the interscalene-block group. All participants will receive standardized general anesthesia. At the end of surgery and before emergence from anesthesia, participants in the combined-block group will receive an ultrasound-guided suprascapular nerve block with 15 mL of 0.25% bupivacaine and an ultrasound-guided PECS I block with 10 mL of 0.25% bupivacaine. Participants in the interscalene-block group will receive an ultrasound-guided interscalene brachial plexus block with 15 mL of 0.5% bupivacaine. Postoperative analgesia will be standardized in both groups using intravenous patient-controlled analgesia with tramadol. Pain intensity will be assessed using the 0-to-10 Numeric Rating Scale at 1, 6, 12, and 24 hours after surgery and during the first supervised postoperative exercise. Rescue analgesia with 50 mg of intravenous tramadol will be administered when the Numeric Rating Scale score is 4 or higher. The primary objective is to determine whether the combined suprascapular nerve and PECS I blocks are non-inferior to the interscalene block with respect to cumulative tramadol consumption during the first 24 postoperative hours. The prespecified non-inferiority margin is 25% of the reference mean tramadol consumption in the interscalene-block group. Hemidiaphragmatic excursion on the operated side will be measured using M-mode ultrasonography before surgery and 30 minutes after block administration in the post-anesthesia care unit. Additional outcomes will include postoperative pain scores, Quality of Recovery-15 score at 24 hours, time to first rescue analgesic administration, postoperative nausea and vomiting, antiemetic consumption, and block-related adverse events, including Horner syndrome, hoarseness, paresthesia, hematoma, and local anesthetic systemic toxicity.
Interventions
PROCEDUREsuprascapular nerve block
At the end of surgery, while the participant is under general anesthesia, an ultrasound-guided suprascapular nerve block will be performed using 15 mL of 0.25% bupivacaine injected into the suprascapular fascial plane through a medial-to-coracoid approach. This intervention will be administered together with the PECS I block in the experimental arm.
PROCEDUREPECS I Block
At the end of surgery, while the participant is under general anesthesia, an ultrasound-guided PECS I block will be performed using 10 mL of 0.25% bupivacaine injected into the fascial plane between the pectoralis major and pectoralis minor muscles. This intervention will be administered together with the suprascapular nerve block in the experimental arm.
PROCEDUREInterscalene Brachial Plexus Block
At the end of surgery, while the participant is under general anesthesia, an ultrasound-guided interscalene brachial plexus block will be performed at the C5-C6 nerve root level using 15 mL of 0.5% bupivacaine injected between the anterior and middle scalene muscles.
Sponsors
Cansu Ofluoğlu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be unaware of their assigned intervention because the regional blocks will be performed at the end of surgery while they are under general anesthesia. The anesthesiologist performing the block will not be masked to group assignment.
Intervention model description
Participants will be randomized in a 1:1 ratio to receive either a combined ultrasound-guided suprascapular nerve block and PECS I block or an ultrasound-guided interscalene brachial plexus block. Both interventions will be performed at the end of surgery while participants are under general anesthesia. Participants will receive the same standardized postoperative analgesic regimen and will be followed for 24 hours after surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75 years * American Society of Anesthesiologists physical status I to III * Scheduled for elective arthroscopic shoulder surgery, including rotator cuff repair, superior labrum anterior-to-posterior lesion repair, Bankart lesion repair, subacromial decompression, or acromioplasty * Able to provide written informed consent * Able to understand and use the study pain-rating scales
Exclusion criteria
* Known allergy or contraindication to local anesthetics * Coagulopathy, defined as an international normalized ratio greater than 1.5 or a platelet count below 80,000/µL * Current anticoagulant or antiplatelet treatment * Active infection or skin lesion at the planned injection site * Severe cardiopulmonary disease, defined as New York Heart Association functional class III or IV or a forced expiratory volume in one second below 50% of the predicted value * Contralateral phrenic nerve paralysis or a single functional lung * Chronic opioid use, defined as daily opioid use for more than 3 months * Regular analgesic use for chronic shoulder pain * History of neuromuscular disease * Pregnancy or breastfeeding * Psychiatric or cognitive condition preventing reliable completion of the study assessments * Revision shoulder surgery * Preexisting neurological deficit in the ipsilateral upper extremity * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Tramadol Consumption During the First 24 Postoperative Hours | From the end of surgery to 24 hours after surgery | The total dose of intravenous tramadol administered to each participant through patient-controlled analgesia and as rescue analgesia will be calculated from the patient-controlled analgesia record and medication chart and reported in milligrams. Higher values indicate greater postoperative analgesic requirement. Cumulative tramadol consumption will be compared between the combined suprascapular nerve and PECS I block group and the interscalene block group to assess non-inferiority of postoperative analgesia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ipsilateral Hemidiaphragmatic Excursion | Preoperative baseline and 30 minutes after block administration in the post-anesthesia care unit | Hemidiaphragmatic excursion on the operated side will be measured in centimeters using M-mode ultrasonography. The mean of three respiratory cycles will be recorded at each assessment. The absolute change and percentage reduction from the preoperative baseline value will be calculated. A greater reduction indicates greater diaphragmatic impairment. |
| Incidence of Hemidiaphragmatic Paresis | 30 minutes after block administration in the post-anesthesia care unit | Hemidiaphragmatic function will be classified according to the percentage reduction in excursion from the preoperative baseline value. A reduction of less than 25% will indicate no paresis, a reduction of 25% to 75% will indicate partial paresis, and a reduction greater than 75% or paradoxical movement will indicate complete paresis. The number and percentage of participants with partial or complete paresis will be reported. |
| Postoperative Pain Intensity at Rest | At 1, 6, 12, and 24 hours after surgery | Pain intensity at rest will be assessed using the 11-point Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded separately at each specified postoperative time point. Lower scores indicate less pain. |
| Pain Intensity During the First Supervised Shoulder Exercise | During the first supervised postoperative shoulder exercise, within 24 hours after surgery | Pain during the first postoperative shoulder exercise performed under orthopedic supervision will be assessed using the 11-point Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate less movement-related pain. |
| Quality of Recovery at 24 Hours | 24 hours after surgery | Postoperative recovery will be evaluated using the 15-item Quality of Recovery questionnaire. The total Quality of Recovery-15 score ranges from 0 to 150, with higher scores indicating better overall postoperative recovery. |
| Time to First Rescue Analgesic Administration | From emergence from anesthesia to 24 hours after surgery | The elapsed time from emergence from general anesthesia to the first administration of rescue analgesia will be recorded in minutes. Rescue analgesia will consist of 50 mg of intravenous tramadol administered when the Numeric Rating Scale pain score is 4 or higher. Participants who do not require rescue analgesia will be censored at 24 hours. |
| Incidence of Postoperative Nausea and Vomiting | During the first 24 hours after surgery | The number and percentage of participants experiencing at least one episode of nausea, vomiting, or both will be recorded. Each participant will be counted once for the overall incidence, regardless of the number of episodes. |
| Rescue Antiemetic Requirement | During the first 24 hours after surgery | The number and percentage of participants who receive at least one dose of rescue antiemetic medication will be recorded. The number of rescue antiemetic doses administered to each participant will also be documented. |
| Incidence of Block-Related Adverse Events | From block administration to 24 hours after surgery | The number and percentage of participants experiencing block-related adverse events will be recorded. Prespecified events include Horner syndrome, hoarseness, paresthesia, injection-site hematoma, and local anesthetic systemic toxicity. Each adverse event will also be recorded separately. |
Countries
Turkey (Türkiye)
Contacts
CONTACTcansu ofluoglu, MD
Outcome results
None listed