Effect of Transversus Abdominis Plane Block With Compound Lidocaine and Esketamine on Pain After Surgery

Study Overview
=================
Brief Summary
-----------------
Purpose: To explore effects of ultrasound-guided transversus abdominis plane block with compound lidocaine and esketamine on postoperative pain after colorectal cancer surgery.

Detailed Description
-----------------
Poor post-surgical pain control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. Recently, the multimodal analgesia strategies to minimise opioid related side effects are highly desirable in open surgical procedures. The transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. Although ropivacaine is most commonly used for this 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 transversus abdominis plane block for abdominal surgery lacks investigations. Herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (USG-TAP) block with compound lidocaine injection and esketamine for postoperative analgesia in patients undergoing colorectal cancer surgery.

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

Conditions
-----------------
Postoperative Pain

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is scheduled to undergo colorectal cancer surgery under general anesthesia Subject's American Society of Anesthesiologists physical status is I-II. 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
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 transversus abdominis plane block<br>Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side. | Drug: Normal saline<br>* Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side<br>* Other names: 0. 9% Sodium Chloride Injection;|
| Active Comparator: Ropivacaine in transversus abdominis plane block<br>Before the induction of anesthesia, 0.375% ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side. | Drug: Ropivacaine<br>* Before the induction of anesthesia, 0.375% ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side<br>* Other names: Ropivacaine Hydrochloride Injection;|
| Active Comparator: Compound lidocaine in transversus abdominis plane block<br>Before the induction of anesthesia, 0.4% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side. | Drug: Compound lidocaine<br>* Before the induction of anesthesia, 0.4% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side<br>* Other names: Compound Lidocaine Hydrochloride Injection;|
| Active Comparator: Compound lidocaine and esketamine in transversus abdominis plane block<br>Before the induction of anesthesia, 0.4% compound lidocaine and 0.4mg/kg esketamine are used for bilateral transversus abdominis plane block in a volume of 20 mL of each side. | Drug: Compound lidocaine<br>* Before the induction of anesthesia, 0.4% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side<br>* Other names: Compound Lidocaine Hydrochloride Injection;Drug: Esketamine<br>* Before the induction of anesthesia, 0.4mg/kg esketamine is used for bilateral transversus abdominis plane block<br>* Other names: Esketamine injection;|

What is the study measuring?
-----------------
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 48 hours postoperatively. | 48 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. | 48 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 48 hours postoperatively. | 48 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 transversus abdominis plane block | Diffusion area of local anesthetics after transversus abdominis plane block was calculated under ultrasound assistance. | 30 minutes after transversus abdominis plane 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. | 48 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. | 48 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. | 48 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Compound lidocaine, Ropivacaine, Transversus abdominis plane block, opioid consumption