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

NCT05122338 | Unknown DMC

• 1 other identifier: GWang021
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postoperative Pain

Keywords

Compound lidocaine; Ropivacaine; Transversus abdominis plane 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 48 hours postoperatively.

  48 hours after surgery

Secondary Outcomes (10)

• Pain Score (NRS)

  48 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

  48 hours after surgery

• Apfel score

  The 1 day before the surgery

Study Arms (4)

Normal saline in transversus abdominis plane block

PLACEBO COMPARATOR

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

Ropivacaine in transversus abdominis plane block

ACTIVE COMPARATOR

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

Compound lidocaine in transversus abdominis plane block

ACTIVE COMPARATOR

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

Compound lidocaine and esketamine in transversus abdominis plane block

ACTIVE COMPARATOR

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; Drug: Esketamine

Interventions

Normal saline DRUG

Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side

Also known as: 0. 9% Sodium Chloride Injection

Normal saline in transversus abdominis plane block

Ropivacaine DRUG

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

Also known as: Ropivacaine Hydrochloride Injection

Ropivacaine in transversus abdominis plane block

Compound lidocaine DRUG

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

Also known as: Compound Lidocaine Hydrochloride Injection

Compound lidocaine and esketamine in transversus abdominis plane block; Compound lidocaine in transversus abdominis plane block

Esketamine DRUG

Before the induction of anesthesia, 0.4mg/kg esketamine is used for bilateral transversus abdominis plane block

Also known as: Esketamine injection

Compound lidocaine and esketamine in transversus abdominis plane 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-II.
• 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

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

Central Study Contacts

Guolin Wang, MD

CONTACT

+8615822855556; 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: November 7, 2021
• First Posted: November 16, 2021
• Study Start: December 1, 2021
• Primary Completion: May 15, 2022
• Study Completion: June 15, 2022
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share