Clinical trial NCT04191850: Ultrasound-Guided Serratus Anterior Plane Block in Pneumothorax Surgery
Official title: Comparison of the Analgesic Effect Between Ultrasound-Guided Serratus Anterior Plane Block and Intercostal Nerve Block After Single Port Video-Assisted Thoracoscopic Surgery in Primary Spontaneous Pneumothorax
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Postoperative Pain
Pneumothorax
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized controlled study was undertaken to compare the postoperative analgesic effect between ultrasound-guided serratus anterior plane block and intercostal nerve block after single port video-assisted thoracoscopic surgery with primary spontaneous pneumothorax.

Detailed description: Post-thoracotomy pain is one of the most notorious postsurgical pains that one can experience. The pain is known to last for an extensive period of time with significantly high intensity.

In field of thoracic surgery, video-assisted thoracoscopic surgery has been played an important role in alleviating the postoperative pain. Furthermore, single-port thoracoscopic surgery, which reduces the number of surgical incision, is increasingly carried out by many institutions world widely.

In field of anesthesiology, various attempts to alleviate post-thoracotomy pain have been tried along advancement of thoracic surgical techniques. It began with postoperative medication of non-steroid anti-inflammatory drugs, opioids and progressed into implementations such as local analgesia, thoracic epidural block, paravertebral block, intercostal nerve block, interpleural block and serratus anterior plane block.

Many analgesic methods have been applied to alleviate postoperative pain in patients who have undergone thoracoscopic surgeries. However, there are no prospective randomized controlled studies between intercostal nerve block and serratus anterior plane block in single port video-assisted thoracoscopic surgeries. The main purpose of this study is to compare and analyze the effects between conventional intercostal nerve block and newly introduced serratus anterior plane block in primary spontaneous pneumothorax patients who have undergone single port video-assisted thoracoscopic wedge resection. This prospective study will discover the efficacy and differences between two methods.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1 or 2
2. primary spontaneous pneumothorax
3. elective single port video-assisted thoracoscopic wedge resection of the lung.

Exclusion Criteria:

1. secondary spontaneous pneumothorax
2. reoperation in ipsilateral thorax
3. a history of drug allergy for analgesics
4. participants who have difficulty understanding the study protocol
5. refusal of participants

Primary outcomes:
measure: Postoperative pain: numeric rating scale
timeFrame: 3 hours later operation
measure: Postoperative pain: numeric rating scale
timeFrame: 6 hours later operation
measure: Postoperative pain: numeric rating scale
timeFrame: 12 hours later operation
measure: Postoperative pain: numeric rating scale
timeFrame: After removal of chest tube
Secondary outcomes:
measure: Number of analgesics consumption
timeFrame: through study completion, an average of 1 year
measure: Amount of analgesics consumption
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Saeyoung Saeyoung
role: PRINCIPAL_INVESTIGATOR
References: