Interscalene Block Versus Anterior Suprascapular Nerve Block for Shoulder Surgery in the Outpatient Setting: Postoperative Pain Managemente and Quality of Recovery With a Multimodal Analgesic Strategy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity at 6 hours after surgery
研究概览
简要总结
Shoulder surgery performed in the outpatient setting can be associated with moderate to severe postoperative pain, especially during the first hours after surgery. Regional anesthesia is commonly used to improve postoperative pain control, reduce opioid use, and support early recovery and safe discharge.
The interscalene block (ISB) is widely considered an effective regional anesthesia technique for shoulder surgery, but it may be associated with adverse effects such as diaphragmatic impairment, dyspnea, hoarseness, Horner syndrome, and prolonged upper limb motor block. The anterior suprascapular nerve block (SSNB-A) is a more selective regional anesthesia technique that may provide comparable postoperative analgesia with fewer block-related adverse effects.
This prospective, randomized, single-blind, noninferiority trial compares SSNB-A with ISB in adult patients undergoing unilateral shoulder surgery in the outpatient setting. All participants receive general anesthesia and the same multimodal analgesic strategy. The primary objective is to determine whether SSNB-A is noninferior to ISB for postoperative pain control, assessed using the Numeric Rating Scale (NRS). Secondary outcomes include quality of recovery measured with the QoR-15 questionnaire, block-related adverse events, sensory and motor block characteristics, and the need for rescue analgesic medication.
详细描述
Shoulder surgery in the outpatient setting requires an anesthetic and analgesic strategy that provides effective postoperative pain control while allowing early recovery and safe discharge. Unilateral shoulder procedures may be associated with moderate to severe postoperative pain, particularly during the first 24 to 48 hours after surgery. In this context, regional anesthesia is an important component of perioperative pain management because it can reduce postoperative pain, decrease the need for opioid analgesics, limit postoperative nausea and vomiting, and facilitate early rehabilitation and recovery.
The interscalene brachial plexus block (ISB) is commonly used for postoperative analgesia after shoulder surgery and is considered one of the most effective regional anesthesia techniques for this indication. However, ISB may be associated with block-related adverse effects, including variable phrenic nerve involvement with diaphragmatic impairment, dyspnea, Horner syndrome, hoarseness, and prolonged motor block of the upper limb. These effects may be particularly relevant in the outpatient setting, where delayed discharge, unplanned admission, or reduced quality of recovery may occur if adverse effects persist after surgery.
The anterior suprascapular nerve block (SSNB-A) has been proposed as a regional anesthesia technique for shoulder surgery that may provide effective analgesia while potentially reducing some of the adverse effects associated with ISB. The suprascapular nerve contributes substantially to the sensory innervation of the shoulder. The anterior approach targets the nerve in the supraclavicular region and may also allow local anesthetic spread toward relevant components of the superior trunk region involved in shoulder innervation. Available evidence suggests that SSNB-A may provide postoperative analgesia comparable to ISB in selected shoulder procedures, with a potentially more favorable side-effect profile.
This study is a prospective, monocentric, randomized, single-blind, noninferiority trial comparing SSNB-A with ISB for postoperative analgesia in adult patients undergoing unilateral shoulder surgery in the outpatient setting. Participants are randomized to receive either an ultrasound-guided interscalene block or an ultrasound-guided anterior suprascapular nerve block before surgery. Randomization is performed shortly before the procedure using block randomization in order to ensure balanced allocation between the two study groups.
Eligible participants are adult patients scheduled for unilateral shoulder surgery in the outpatient setting under general anesthesia. Surgical procedures may include long head of biceps tenotomy, biceps anchor repair, Bankart procedure, rotator cuff repair with or without biological membrane augmentation, subacromial decompression, acromioplasty, and acromioclavicular stabilization. Participants are screened according to predefined inclusion and exclusion criteria. Exclusion criteria include contraindications to regional anesthesia, allergy to local anesthetics or study analgesic drugs, known neuropathy or sensory or motor deficits in the surgical area or block territory, severe obesity, severe chronic obstructive pulmonary disease, pregnancy, known phrenic nerve paralysis with diaphragmatic paralysis, chronic opioid use, severe chronic pain, and inability or unwillingness to follow the postoperative analgesic protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and postoperative outcome assessors are blinded to treatment allocation. The anesthesiologist performing the regional anesthesia technique is not blinded because the two blocks require different anatomical approaches. Postoperative data collection is performed by assessors unaware of grous assignment
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •ASA physical status I, II, or III.
- •Scheduled for unilateral shoulder orthopedic surgery in the outpatient/day surgery setting under general anesthesia.
- •Surgical procedures may include long head of biceps tenotomy, biceps anchor repair, Bankart procedure, rotator cuff repair with or without biological membrane augmentation, subacromial decompression, acromioplasty, or acromioclavicular stabilization.
- •Ability to understand the study procedures and provide written informed consent.
排除标准
- •Contraindication to regional anesthesia, including allergy to local anesthetics, infection at the injection site, bleeding diathesis, or other contraindications according to applicable clinical practice recommendations.
- •Allergy to paracetamol or to any drug used in the multimodal rescue analgesic strategy.
- •Known neuropathy or sensory/motor deficit in the surgical area or in the territory of innervation of the study blocks.
- •History of psychiatric or behavioral disorders that may interfere with study participation or outcome assessment.
- •Severe obesity, defined as body mass index (BMI) > 40 kg/m
- •Severe chronic obstructive pulmonary disease, GOLD stage III-IV.
- •Pregnancy.
- •Known phrenic nerve palsy associated with diaphragmatic paralysis.
- •Chronic opioid use during the previous 3 months.
- •Severe chronic pain during the previous 3 months, defined as NRS >
- •Non-adherence to the postoperative analgesic protocol.
研究组 & 干预措施
Interscalene block
Participants randomized to this group receive an ultrasound-guided interscalene brachial plexus block before shoulder surgery, followed by standardized general anesthesia and the same multimodal postoperative analgesic protocol used in both study groups.
干预措施: Interscalene Nerve Block (Procedure)
Anterior Suprascapular Nerve Block
Participants randomized to this group receive an ultrasound-guided anterior suprascapular nerve block before shoulder surgery, followed by standardized general anesthesia and the same multimodal postoperative analgesic protocol used in both study groups.
干预措施: Anterior suprascapular nerve block (Procedure)
Interscalene block
Participants randomized to this group receive an ultrasound-guided interscalene brachial plexus block before shoulder surgery, followed by standardized general anesthesia and the same multimodal postoperative analgesic protocol used in both study groups.
干预措施: Ropivacaine (Drug)
Anterior Suprascapular Nerve Block
Participants randomized to this group receive an ultrasound-guided anterior suprascapular nerve block before shoulder surgery, followed by standardized general anesthesia and the same multimodal postoperative analgesic protocol used in both study groups.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Postoperative pain intensity at 6 hours after surgery
时间窗: 6 hours after surgery
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary analysis compares NRS pain scores between the anterior suprascapular nerve block group and the interscalene block group to assess noninferiority.
次要结局
- Postoperative Pain Intensity at Other Predefined Postoperative Time Points(At post-anesthesia care unit arrival and at 12, 18, 24, 36, 48, and 72 hours after surgery)
- Quality of Recovery(On postoperative day 0, postoperative day 1, postoperative day 2, postoperative day 3, and postoperative day 5)
- Incidence of Block-Related Adverse Events(From block performance through postoperative day 0)
- Rescue Analgesic Consumption(From post-anesthesia care unit arrival through postoperative day 5)
- Sensory and Motor Block Characteristics(At 30 minutes after block performance, at post-anesthesia care unit arrival, and 6 hours after surgery)
研究者
Giorgio Rossoni
MD
Ospedale di Circolo - Fondazione Macchi
