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

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

Purpose:

To explore effects of ultrasound-guided quadratus lumborum block with compound lidocaine and esketamine on postoperative pain after colorectal 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 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.

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

Contacts and Locations

• Study Contact: Name: Guolin Wang, MD; Phone Number: +86 15822855556; Email: wangguolinghad@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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-III.
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 quadratus lumborum block; 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; After the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side; Other Names: 0. 9% Sodium Chloride Injection
Active Comparator: Ropivacaine in quadratus lumborum block; 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; After the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side; Other Names: Ropivacaine Hydrochloride Injection
Active Comparator: Compound lidocaine in quadratus lumborum block; 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; 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; Other Names: Compound Lidocaine Hydrochloride Injection
Active Comparator: Compound lidocaine and esketamine in quadratus lumborum block; 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; 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; Other Names: Compound Lidocaine Hydrochloride Injection; Drug: Esketamine; After the induction of anesthesia, 0.4mg/kg esketamine is used for bilateral quadratus lumborum 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 72 hours postoperatively.	72 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
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
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
Mean time until passage of flatus	Gastrointestinal motility was evaluated by recording mean time until passage of flatus	96 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.	72 hours 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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 6, 2023
• Primary Completion (Estimated): January 15, 2024
• Study Completion (Estimated): February 15, 2024

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Esketamine; opioid consumption; Compound lidocaine; Quadratus lumborum block
• 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: GWang023

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