Effect of Quadratus Lumborum Block With Compound Lidocaine and Esketamine on Pain After Colorectal Surgery

Study Overview
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Brief Summary
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Purpose: To explore effects of ultrasound-guided quadratus lumborum block with compound lidocaine and esketamine on postoperative pain after colorectal surgery.

Detailed Description
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Poor post-surgical pain control is a leading factor that hinders the physicalrehabilitation, and causes acute cognitive impairment and chronic painsyndrome. Recently, the multimodal analgesia strategies to minimise opioidrelated side effects are highly desirable in open surgical procedures. Quadratus lumborum block is a novel technique. Although ropivacaine is most commonly used forthis technique, the analgesic duration remains not dissatisfied. Compared with ropivacaine, compound lidocaine injection has a better and longer analgesic activity since it contains menthol and ethanol with appropriate concentrations. However, whether compound lidocaine injection is efficiency in the quadratus lumborum block for abdominal surgery lacks investigations. Herein, we will evaluate the efficacy of ultrasound-guided quadratus lumborum block (USG-QLB) with compound lidocaine injection and esketamine for postoperative analgesia in patients undergoing colorectal surgery.

Official Title
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Effect of Ultrasound-guided Quadratus Lumborum Block With Compound Lidocaine and Esketamine on Postoperative Pain in Patients Undergoing Colorectal Surgery: a Randomized Double-blind Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Normal saline
* Drug: Ropivacaine
* Drug: Compound lidocaine
* Drug: Esketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is scheduled to undergo colorectal cancer surgery under general anesthesia Subject's American Society of Anesthesiologists physical status is I-III. The subject's parent/legally authorized guardian has given written informed consent to participate Exclusion Criteria: Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure. Subject has a diagnosis of Insulin dependent diabetes. Subject is allergy and contraindication to local anesthetics or any components of local anesthetics. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery. Subject has any contraindication for the use of patient-controlled analgesia (PCA). Subject is pregnant or breast-feeding. Subject is obese (body mass index >30kg/m^2). Subject is incapacity to comprehend pain assessment and cognitive assessment.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal saline in quadratus lumborum block<br>After the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side. | Drug: Normal saline<br>* After the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side<br>* Other names: 0. 9% Sodium Chloride Injection;|
| Active Comparator: Ropivacaine in quadratus lumborum block<br>After the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side. | Drug: Ropivacaine<br>* After the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side<br>* Other names: Ropivacaine Hydrochloride Injection;|
| Active Comparator: Compound lidocaine in quadratus lumborum block<br>After the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side. | Drug: Compound lidocaine<br>* After the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side<br>* Other names: Compound Lidocaine Hydrochloride Injection;|
| Active Comparator: Compound lidocaine and esketamine in quadratus lumborum block<br>After the induction of anesthesia, 0.6% compound lidocaine and 0.4 mg/kg esketamine are used for bilateral quadratus lumborum block in a volume of 20 mL of each side. | Drug: Compound lidocaine<br>* After the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side<br>* Other names: Compound Lidocaine Hydrochloride Injection;Drug: Esketamine<br>* After the induction of anesthesia, 0.4mg/kg esketamine is used for bilateral quadratus lumborum block<br>* Other names: Esketamine injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption | Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing opioid in normal saline after leaving PACU (Postanesthesia care unit). Opioid cumulative consumption is recorded for 72 hours postoperatively. | 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score (NRS) | The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10= greatest imaginable pain. | 72 hours after surgery | 
| Time of First Postoperative Analgesic Requirement | First postoperative pain (NRS≥5) is initially controlled by titration of opioid. | 1 hour after surgery | 
| Total Dose of First Postoperative Analgesic Requirement | First postoperative pain (NRS≥5) is initially controlled by titration of opioid. | 1 hour after surgery | 
| The incidence of Side Effects | The number of patients with side effects including nausea, vomiting, dizziness, headache, shivering, and pruritus is recorded for 72 hours postoperatively. | 72 hours after surgery | 
| Apfel score | The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV). | The 1 day before the surgery | 
| Mean time until passage of flatus | Gastrointestinal motility was evaluated by recording mean time until passage of flatus | 96 hours after surgery | 
| Diffusion area of local anesthetics after quadratus lumborum block | Diffusion area of local anesthetics after quadratus lumborum block was calculated under ultrasound assistance. | 30 minutes after quadratus lumborum block | 
| Normalized Area of Hyperalgesia Around the Incision | The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper' feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament. | 72 hours after surgery | 
| The level of cytokines in blood By ELISA kits | Blood is collected to measure the level of cytokines (such as IL-18, IL-17, IL-23 ) using ELISA kits. | 72 hours after surgery | 
| The level of chemokines in blood By ELISA kits | Blood is collected to measure the level of chemokines (such as CXCL1, CCL7, CCL2) using ELISA kits. | 72 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compound lidocaine, Esketamine, Quadratus lumborum block, opioid consumption