Clinical trial NCT06160375: Erector Spine Plane Block Versus Single-injection Thoracic Paravertebral Block Via Intrathoracic Approach in Single-port Video-assisted Thoracoscopic Lung Surgeries
Official title: Effect of Ultrasound-guided Erector Spine Plane Block Versus Single-injection Thoracic Paravertebral Block Via Intrathoracic Approach in Single-port Video-assisted Thoracoscopic Lung Surgeries in Postoperative Analgesia: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracoscopic Surgeries
Keywords: thoracoscopic surgery
paravertebral block
erector spine block
ultrasound guided
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of ultrasound-guided erector spine plane block versus single-injection thoracic paravertebral block via intrathoracic approach in single-port video-assisted thoracoscopic lung surgeries in postoperative analgesia: a randomized controlled trial.

Detailed description: Traditional thoracotomy has great trauma and severe postoperative pain. At present, thoracoscopic minimally invasive surgery is the main method of thoracic surgery. Recently, single-port video-assisted thoracoscopic (SPVAT) surgery has been widely used in thoracic surgery, especially in lung wedge resection. SPVAT lung wedge resection has the advantages of less incision, less pain, and faster recovery. It was considered to have mild postoperative pain, and ignored the need for postoperative analgesia, resulting in insufficient analgesic measures after surgery. The postoperative pain is still severe, which seriously affects the patient's postoperative recovery Pain is more than just a physical process; it is a complex, subjective phenomenon. Pain can impair the hematologic, immune, hormonal, cardiac, and respiratory systems. Pain also can limit mobility, interfere with sleep and rest, and contribute to agitation, Psychosis, aggressive behavior, and delirium. Surgical centers need to pay attention to pain management because there appears to be a direct relationship between unrelieved pain and the cost of medical care, time spent in an intensive care unit, and length of hospital stay.

Inadequate analgesia causes respiratory, hemodynamic, endocrine, and metabolic complications. The preferred drugs for postoperative pain management are opioids. Usually, morphine is used for hemodynamic stability but it has a series of side effects like nausea, vomiting, constipation, and respiratory depression. NSAIDs are also used for analgesia. It also has some side effects such as gastrointestinal disturbance, renal impairment, decreased platelet function, and impaired coagulation.

Ultrasound guidance is rapidly becoming the gold standard for regional anesthesia. There is an ever-growing weight of evidence, matched with improving technology, to show that the use of ultrasound has significant benefits. The improved safety and efficacy that ultrasound brings to regional anesthesia will help promote its use and realize the benefits that regional anesthesia has, such as decreased morbidity and mortality, superior postoperative analgesia, cost-effectiveness, decreased postoperative complications, and an improved postoperative course. Although the risk of complications is minimized with the use of ultrasound, it requires advanced experience owing to its proximity to the pleura, epidural, and subarachnoid distance.

A simpler, quicker, effective, less invasive, and less complicated analgesic method can be used for postoperative analgesia after SPVAT lung wedge resection is to inject local anesthetics (LAs) directly into the paravertebral space via the intrathoracic approach under thoracoscopic direct vision to achieve the purpose of TPB under thoracoscopic direct vision, thereby reducing postoperative pain.

The erector spine plane block (ESPB) is a new technique that is easier to visualize and perform because it is more superficial. Owing to these advantages, it has been preferred frequently for postoperative analgesia in different types of operations such as thorax, abdomen, hip, and lumbar surgeries in recent years.

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Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years
* American Society of Anesthesiologists (ASA) physical status of I and II,
* Having body mass index (BMI) \<35 kg/m2, pneumothorax, and bullae or lung nodules considered carcinoma in situ with a requirement for minimally invasive surgery and the patient will have single-port VATS.

Exclusion Criteria:

* Patient's refusal
* Age \<18, pregnancy
* Spinal deformity or spinal surgical history
* Renal, hepatic patient,
* Allergies to local anesthetics.

Primary outcomes:
measure: postoperative cumulative morphine consumption in the first 24 hours.
timeFrame: 24 hours
Secondary outcomes:
measure: 1st postoperative rescue analgesic
timeFrame: discharge from OR to time to 1st dose of morphine
measure: numerical rating scale
timeFrame: at the PACU, 2 hours, 4 hours, 6 hours, 18 hours, and at 24 hours post operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: