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Purpose: to evaluate the efficacy and safety of erector spinal block (ESB) for analgesia in laparoscopic cholecystectomy（LC）.
Method: This study is a randomized, single-blind, controlled clinical trial. Pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. Vertebral side block will be performed in the VSB group. And the control group will receive local anaesthesia after the surgery. Intraoperative and postoperative analgesia effect and side effects will be compared between the three groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erector spinal plane block group (ESPB group) | Experimental | After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. |
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| Vertebral side block group (VSB group) | Active Comparator | After induction of general anesthesia, pre-operative ultrasound-guided bilateral vertebral side block will be performed in the VSB group. |
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| Local block group （LB group） | Placebo Comparator | Local block will be performed at the surgical incisions after the surgery under general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector spinal plane block | Procedure | After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block/ vertebral side block will be performed in the ESPB/VSB group. Local block will be performed at the surgical incisions after the surgery under general anesthesia. All the intervention will be performed without patients' awareness. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity at rest(Hour 2) | Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest two hours after the surgery. | Hour 2 |
| Pain intensity at rest (Hour 6) | Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest six hours after the surgery. | Hour 6 |
| Pain intensity at rest (Hour 24) | Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest 24 hours after the surgery. | Hour 24 |
| Measure | Description | Time Frame |
|---|---|---|
| The overall dose of remifentanil | The overall dose of remifentanil used in the surgery. | During the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siyi YAN, MD | Contact | 86+010-56119610 | yansiyi03@hotmail.com | |
| Chen Yu, MD | Contact | 86+010-56119353 | yca01089@btch.edu.cn |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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A randomized, single-blinded, controlled clinical trial
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |