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

Sponsor

Tianjin Medical University General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05964985

Collaborator

(none)

160

Enrollment

Arms

6.3

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Purpose:

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Normal saline Drug: Ropivacaine Drug: Compound lidocaine Drug: Esketamine	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 6, 2023

Anticipated Primary Completion Date :

Jan 15, 2024

Anticipated Study Completion Date :

Feb 15, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Postoperative opioid consumption [72 hours after surgery]
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.

Secondary Outcome Measures

Pain Score (NRS) [72 hours after surgery]
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.
Time of First Postoperative Analgesic Requirement [1 hour after surgery]
First postoperative pain (NRS≥5) is initially controlled by titration of opioid.
Total Dose of First Postoperative Analgesic Requirement [1 hour after surgery]
First postoperative pain (NRS≥5) is initially controlled by titration of opioid.
The incidence of Side Effects [72 hours after surgery]
The number of patients with side effects including nausea, vomiting, dizziness, headache, shivering, and pruritus is recorded for 72 hours postoperatively.
Apfel score [The 1 day before the surgery]
The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
Mean time until passage of flatus [96 hours after surgery]
Gastrointestinal motility was evaluated by recording mean time until passage of flatus
Diffusion area of local anesthetics after quadratus lumborum block [30 minutes after quadratus lumborum block]
Diffusion area of local anesthetics after quadratus lumborum block was calculated under ultrasound assistance.
Normalized Area of Hyperalgesia Around the Incision [72 hours after surgery]
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.
The level of cytokines in blood By ELISA kits [72 hours after surgery]
Blood is collected to measure the level of cytokines (such as IL-18, IL-17, IL-23 ) using ELISA kits.
The level of chemokines in blood By ELISA kits [72 hours after surgery]
Blood is collected to measure the level of chemokines (such as CXCL1, CCL7, CCL2) using ELISA kits.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.