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non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace

non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace

Sulfentanyl

The aim of this study is to study the safety and effectiveness of the effects on the perioperative pain control comparing between the thoracic paravertebral nerve block using the camera guided and the intrathoracic intercostals nerve block for the management of nonintubated local regional analgesia in uniport thoracoscopic surgery for the undetermined solitary nodules patients.

Thoracoscopic minor lung resection has been the reasonable option for the diagnosis and treatment of management of the undetermined peripheral pulmonary nodules. Uniport procedure could reduce postoperative pain score, the length of hospital stay, moreover, nonintubated technique can avoid the disadvantages of conventional general anesthesia such as ventilator induced lung injury, sore throat or voice change. The nonintubated technique without tracheal intubation under spontaneous ventilation combined with uniport or single port thoracoscopic surgery has emerged as the least invasive procedure of wedge resection of peripheral pulmonary nodules, even the anatomical thoracoscopic lobectomy along with mediastinal lymph nodule dissection in case of the diagnosis of the primary lung cancer during the operation.

The initial experience of nonintubated thoracoscopic surgery included the intravenous controlled sedation and pain , thoracic epidural analgesia and thoracic vagus nerve block, due to series of adverse events of the epidural analgesia, operator was willing to perform the intrathoracic intercostal nerve block guided by camera during the operation and was considered as the simple and safety method for regional analgesia .However, the intercostal nerve block can not employ the adequate pain control ,after the surgery, the patient controlled analgesia is as usual needed.

The previous study showed that paravertebral block was the same effect on relieved pain as thoracic epidural analgesia and had the less complications such as hypotension, nausea or vomiting. With the advance in the technique of application of ultrasound, it is more interesting that using the ultrasound technique before the surgery is performed for the adequate pain control of the local regional analgesia in nonintubated surgery under spontaneous ventilation. However, ultrasound technique is difficult to have the skilled experience for the most anaesthetists and increase the related puncture complications such as hematoma, bleeding or pneumothorax. The method used study is guided by camera which is very simple and safety by avoidance of the puncture of the partial pleura or intercostal blood vessel, The investigators once used this approach for postoperative pain control under general intubation for lung cancer patients, so the investigators have had a skilled experience for achieving regional analgesia of nonintubated uniport thoracoscopic wedge resection.

So far, there has been no articles about thoracic paravertebral nerve block for regional analgesia of nonintubated thoracoscopic procedure patients. The investigators designed the study to compare the short term outcome on thoracic paravertebral nerve block in nonintubated technique with those of intercostal nerve block in uniport nonintubated video-assisted thoracoscopic surgery(VATS) as the control group.

This study will be performed at the third people's hospital of Shenzhen. A total of 48 patients will be enrolled(24 patients in each arms).

Comparative Study of Nonintubated Uniport Thoracoscopic Surgery Using Thoracic Paravertebral Nerve Block Versus Intercostal Nerve Block for Peripheral Solitary Pulmonary Nodule Patients

the Safety and Effectiveness of the Effects on the Perioperative Pain Control Comparing Between the Thoracic Paravertebral Nerve Block Using the Camera Guided and the Intrathoracic Intercostals Nerve Block for the Management of Nonintubated Local Regional Analgesia in Uniport Thoracoscopic Surgery for the Undetermined Solitary Nodules Patients

there is not a plan to make individual participant data available to other researcher.

data of arterial partial pressure of oxygen(PaO2) and PaCO2 at different point during the operation

Shenzhen Third People's Hospital

Director, Head of thoracic surgical department, Principal investigator, Associate clinical professor

non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace

Propofol: anaesthetic

Sulfentanyl: anaesthetic

Dexmedetomidine: anaesthetic

Lidocaine: local anaesthetics

Ropivacaine: local anaesthetics

Paravertebral Nerve Block Group

non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace

Propofol: anaesthetic

Sulfentanyl: anaesthetic

Dexmedetomidine: anaesthetic

Lidocaine: local anaesthetics

Ropivacaine: local anaesthetics

Intercostals Nerve Block Group

paravertebral nerve block and intercostal nerve block

Per Arm

there is two arms for the overall subjects divided into the two different regional anesthesia.

Age, Continuous

there is two arms for the overall subjects of this study divided into the two different regional anesthsia

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Thoracic surgical department

Interleukin-6 T0

Interleukin-6 T1

Interleukin-6 T2

Interleukin-6 T3

Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group

During the operation, 0m

During the operation, 15m

During the operation, 30m

During the operation, 60m

Concentration of Cortisol at Different Point During the Operation

mean arterial pressure T0

mean arterial pressure T1

mean arterial pressure T2

mean arterial pressure T3

Comparing the Hemodynamics of the Intervention of the Each Group During the Operation

heart rate T0

heart rate T1

heart rate T2

heart rate T3

arterial partial pressure of oxygen(PaO2)

arterial partial pressure of PaC

Comparing the Blood Gas Analysis After the Intervention of the Each Group

hematoma

pain of punture position

Number of Participants With Puncture Related Complications

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Psychotropic Drugs

Rocuronium

Midazolam

Remifentanil

The T Group received PECS II(PMID: 22939099) combined with intercostal nerve block

C Group underwent laryngeal mask insertion after general anesthesia induction.

The patient was in a supine position, and under ultrasound guidance, the needle tip was first placed in the plane between the pectoralis major and minor muscles, and 10ml of 0.3% ropivacaine was injected. The needle was then advanced into the space between the pectoralis minor and serratus anterior muscles, and 20ml of 0.3% ropivacaine was injected. Intercostal nerve blockade: The range of intercostal blockade was determined based on the location of the breast surgery. The needle was inserted into the intercostal space from the posterior axillary line, and 3ml of 0.3% ropivacaine was injected into each intercostal space.

PECS II combined with intercostal nerve blockade;

The C Group underwent general anesthesia induction using TCI propofol 3-3.5μg/ml, TCI remifentanil 1-2ng/ml, sufentanil 0.3μg/kg iv, midazolam 0.05mg/kg iv, and rocuronium 0.6mg/kg iv after loss of consciousness. After muscle relaxation, the laryngeal mask was inserted, and mechanical ventilation was performed with a tidal volume of 6ml/kg. Anesthesia maintenance included propofol 3-4μg/ml and remifentanil 1-2ng/ml.

General anesthesia with laryngeal mask

Jun Zhang, PhD

Dandan Ling, MD

The aim of this randomized controlled trial (RCT) is to assess the Quality of Recovery (QoR) in Breast-conserving Surgery (BCS) with Sentinel Lymph Node Biopsy (SLNB) using Pectoral Nerves (PECS) Block and General Anesthesia (GA). The primary objectives are as follows: First, to determine if the PECS group exhibits better QoR; Second, to investigate if the PECS group experiences less postoperative pain and complications; Third, to examine if the PECS group demonstrates more stable hemodynamics.

This study is a randomized controlled trial, with a 1:1 ratio for grouping. The experimental group is the T group, receiving Pecs II combined with intercostal nerve block, while the control group is the C group, receiving general anesthesia. The primary outcome measure is the QoR-15 score of the subjects 6 hours after surgery. Based on preliminary results, the control group had a QoR-15 score of 133±8 (n=6), and the experimental group needs to improve by at least 8 points (which is generally considered clinically significant, PMID:27159009). With a two-sided α=0.05 and a power of 99%, accounting for a 20% dropout rate, the final required sample size was calculated to be 96 cases, with 48 cases in each group.

If the proportion of dropout cases is less than 5% and considered "completely random missing," the missing records generated by the dropout cases will be directly excluded. Depending on the specific circumstances, either single imputation or multiple imputation methods will be used.

The nerve block group was named the test group (T Group), and the laryngeal mask general anesthesia group was named the control group (C Group). The T Group received PECS II combined with intercostal nerve blockade, while the C Group underwent laryngeal mask insertion after general anesthesia induction.

The follow-up personnel and data analysts are blind.

Comparing the QoR of PECS Block and GA in Breast-conserving Surgery With Sentinel Lymph Node Biopsy

Comparing the Quality of Recovery(QoR) of Pectoral Nerves(PECS) Block and General Anesthesia(GA) in Breast-conserving Surgery(BCS) With Sentinel Lymph Node Biopsy(SLNB):A Randomized Controlled Trial

The 15-item quality of recovery(QoR-15) at 2 hours after the surgery.

The 15-item quality of recovery(QoR-15) at 24 hours after the surgery.

Postoperative numeric rating scales pain score at 2 hours after the surgery. Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. The numerical rating scale (NRS) is a line with numbers from 0 to 10 are spaced evenly across the page. And the NRS is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable". Pain levels below "4" are considered mild, "4-7" is moderate pain, and anything above "7" is considered severe pain. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. The movement status refers to maximum mobility of the upper arm of the surgical side. Remedial pain relief measures are initiated when the Numeric Rating Scale (NRS) score exceeds 4.

Postoperative numeric rating scales pain score at 24 hours after the surgery. Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. The numerical rating scale (NRS) is a line with numbers from 0 to 10 are spaced evenly across the page. And the NRS is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable". Pain levels below "4" are considered mild, "4-7" is moderate pain, and anything above "7" is considered severe pain. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. The movement status refers to maximum mobility of the upper arm of the surgical side. Remedial pain relief measures are initiated when the Numeric Rating Scale (NRS) score exceeds 4.

The number of patients requiring additional analgesics for rescue analgesia after the surgery is completed.

A systolic blood pressure below 80mmHg is defined as hypotension. Record the number of patients who experience intraoperative hypotension.

During the surgery and anesthesia process, a heart rate below 45 bpm is defined as intraoperative Bradycardia. Record the number of patients who experience intraoperative Bradycardia.

A heart rate below 45 bpm is defined as Bradycardia. Record the number of patients who experience Bradycardia.

Proportion of patients experiencing postoperative nausea and vomiting at least once at 24 hours postoperatively.

The 15-item quality of recovery(QoR-15) at 6 hours after the surgery.

Postoperative numeric rating scales pain score at 6 hours after the surgery. Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. The numerical rating scale (NRS) is a line with numbers from 0 to 10 are spaced evenly across the page. And the NRS is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable". Pain levels below "4" are considered mild, "4-7" is moderate pain, and anything above "7" is considered severe pain. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. The movement status refers to maximum mobility of the upper arm of the surgical side. Remedial pain relief measures are initiated when the Numeric Rating Scale (NRS) score exceeds 4.

During the surgery and anesthesia process, a systolic blood pressure below 80mmHg is defined as intraoperative hypotension. Record the number of patients who experience intraoperative hypotension.

Monitor the magnitude of hemodynamic changes compared to baseline after the incision. The main comparison is the magnitude of changes in mean arterial pressure between the two groups.

Monitor the magnitude of hemodynamic changes compared to baseline after the incision. The main comparison is the magnitude of changes in heart rate between the two groups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparative Study of Nonintubated Uniport Thoracoscopic Surgery Using Thoracic Paravertebral Nerve Block Versus Intercostal Nerve Block for Peripheral Solitary Pulmonary Nodule Patients	NCT03086213	Peripheral Soli...	Propofol Sulfentanyl Dexmedetomidine Lidocaine Ropivacaine	18 Years - 65 Years	Shenzhen Third People's Hospital
Comparative Study of Nonintubated Uniport Thoracoscopic Surgery Using Thoracic Paravertebral Nerve Block Versus Intercostal Nerve Block for Peripheral Solitary Pulmonary Nodule Patients	NCT03086213	Peripheral Soli...	Propofol Sulfentanyl Dexmedetomidine Lidocaine Ropivacaine	18 Years - 65 Years	Shenzhen Third People's Hospital
Comparing the QoR of PECS Block and GA in Breast-conserving Surgery With Sentinel Lymph Node Biopsy	NCT06120439	Breast Cancer Pectoral Nerves... Breast-Conservi... Sentinel Lymph ...	PECS II combine... General anesthe...	18 Years - 70 Years	Fudan University
Comparing the QoR of PECS Block and GA in Breast-conserving Surgery With Sentinel Lymph Node Biopsy	NCT06120439	Breast Cancer Pectoral Nerves... Breast-Conservi... Sentinel Lymph ...	PECS II combine... General anesthe...	18 Years - 70 Years	Fudan University

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