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Clinical Trials/NCT05964985
NCT05964985
Not yet recruiting
Not Applicable

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

Tianjin Medical University General Hospital0 sites160 target enrollmentAugust 6, 2023

Overview

Phase
Not Applicable
Intervention
Normal saline
Conditions
Postoperative Pain
Sponsor
Tianjin Medical University General Hospital
Enrollment
160
Primary Endpoint
Postoperative opioid consumption
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

Purpose:

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

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.

Registry
clinicaltrials.gov
Start Date
August 6, 2023
End Date
February 15, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guolin Wang

Professor

Tianjin Medical University General Hospital

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-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.

Arms & Interventions

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.

Intervention: Normal saline

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.

Intervention: Ropivacaine

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.

Intervention: Compound lidocaine

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.

Intervention: Compound lidocaine

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.

Intervention: Esketamine

Outcomes

Primary Outcomes

Postoperative opioid consumption

Time Frame: 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 Outcomes

  • Pain Score (NRS)(72 hours after surgery)
  • Time of First Postoperative Analgesic Requirement(1 hour after surgery)
  • The incidence of Side Effects(72 hours after surgery)
  • The level of cytokines in blood By ELISA kits(72 hours after surgery)
  • The level of chemokines in blood By ELISA kits(72 hours after surgery)
  • Total Dose of First Postoperative Analgesic Requirement(1 hour after surgery)
  • Apfel score(The 1 day before the surgery)
  • Mean time until passage of flatus(96 hours after surgery)
  • Diffusion area of local anesthetics after quadratus lumborum block(30 minutes after quadratus lumborum block)
  • Normalized Area of Hyperalgesia Around the Incision(72 hours after surgery)

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