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

NCT05964985 | Unknown DMC

• 1 other identifier: GWang023
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postoperative Pain

Keywords

Compound lidocaine; Esketamine; Quadratus lumborum block; opioid consumption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Pain Score (NRS)

  72 hours after surgery

• Time of First Postoperative Analgesic Requirement

  1 hour after surgery

• Total Dose of First Postoperative Analgesic Requirement

  1 hour after surgery

• The incidence of Side Effects

  72 hours after surgery

• Apfel score

  The 1 day before the surgery

Study Arms (4)

Normal saline in quadratus lumborum block

PLACEBO COMPARATOR

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

Ropivacaine in quadratus lumborum block

ACTIVE COMPARATOR

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

Compound lidocaine in quadratus lumborum block

ACTIVE COMPARATOR

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

Compound lidocaine and esketamine in quadratus lumborum block

ACTIVE COMPARATOR

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; Drug: Esketamine

Interventions

Normal saline DRUG

After the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side

Also known as: 0. 9% Sodium Chloride Injection

Normal saline in quadratus lumborum block

Ropivacaine DRUG

After the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side

Also known as: Ropivacaine Hydrochloride Injection

Ropivacaine in quadratus lumborum block

Compound lidocaine DRUG

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

Also known as: Compound Lidocaine Hydrochloride Injection

Compound lidocaine and esketamine in quadratus lumborum block; Compound lidocaine in quadratus lumborum block

Esketamine DRUG

After the induction of anesthesia, 0.4mg/kg esketamine is used for bilateral quadratus lumborum block

Also known as: Esketamine injection

Compound lidocaine and esketamine in quadratus lumborum block

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Saline Solution; Sodium Chloride; Ropivacaine; Esketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Guolin Wang, MD

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

Central Study Contacts

Guolin Wang, MD

CONTACT

+86 15822855556; wangguolinghad@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: August 6, 2023
• Primary Completion: January 15, 2024
• Study Completion: February 15, 2024
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share