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

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

Purpose:

To explore effects of ultrasound-guided transversus abdominis plane block with compound lidocaine and esketamine on postoperative pain after colorectal cancer surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Normal saline; Drug: Ropivacaine; Drug: Compound lidocaine; Drug: Esketamine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is scheduled to undergo colorectal cancer surgery under general anesthesia
2. Subject's American Society of Anesthesiologists physical status is I-II.
3. The subject's parent/legally authorized guardian has given written informed consent to participate.

Exclusion Criteria:

1. Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure.
2. Subject has a diagnosis of Insulin dependent diabetes.
3. Subject is allergy and contraindication to local anesthetics or any components of local anesthetics.
4. 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.
5. Subject has any contraindication for the use of patient-controlled analgesia (PCA).
6. Subject is pregnant or breast-feeding.
7. Subject is obese (body mass index >30kg/m^2).
8. Subject is incapacity to comprehend pain assessment and cognitive assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Normal saline in transversus abdominis plane block; 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; Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side; Other Names: 0. 9% Sodium Chloride Injection
Active Comparator: Ropivacaine in transversus abdominis plane block; 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; 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; Other Names: Ropivacaine Hydrochloride Injection
Active Comparator: Compound lidocaine in transversus abdominis plane block; 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; 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; Other Names: Compound Lidocaine Hydrochloride Injection
Active Comparator: Compound lidocaine and esketamine in transversus abdominis plane block; 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; 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; Other Names: Compound Lidocaine Hydrochloride Injection; Drug: Esketamine; Before the induction of anesthesia, 0.4mg/kg esketamine is used for bilateral transversus abdominis plane block; 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
Apfel score	The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).	The 1 day before the 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
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
Mean time until passage of flatus	Gastrointestinal motility was evaluated by recording mean time until passage of flatus	96 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

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital
• Investigators: Study Director: Guolin Wang, Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): May 15, 2022
• Study Completion (Anticipated): June 15, 2022

Study Registration Dates

• First Submitted: November 7, 2021
• First Submitted That Met QC Criteria: November 13, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 13, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Ropivacaine; opioid consumption; Transversus abdominis plane block; Compound lidocaine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Psychotropic Drugs; Membrane Transport Modulators; Antidepressive Agents; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Ropivacaine; Esketamine
• Other Study ID Numbers: GWang021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No