Effect of Ultrasound-guided Transversus Abdominis Plane Block After Laparoscopic Bariatric Surgery

NCT05286008 | Unknown DMC

• 1 other identifier: GWang022
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

To explore and compare Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative nausea and vomiting and Early Outcome After Laparoscopic Bariatric Surgery To evaluate and examine TAPB can reduce the application of intraoperative and postoperative opioids and the duration of analgesia

Conditions

Postoperative Nausea and Vomiting; Postoperative Pain

Keywords

Ropivacaine; Transversus abdominis plane block; opioid consumption; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Postoperative nausea and vomiting

  The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).

  72 hours after surgery

Secondary Outcomes (10)

• cumulative Sufentanyl Consumption during surgery

  during surgery

• cumulative Sufentanyl Consumption after surgery

  48 hours after surgery

• Time of First Postoperative Analgesic Requiremen

  1hour after surgery

• Total Dose of First Postoperative Analgesic Requirement

  1hour after surgery

• The incidence of Side Effects

  48 hours after surgery

Study Arms (3)

Normal Saline

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 at high concentration

EXPERIMENTAL

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 at high concentration

Ropivacaine and dexamethasone

EXPERIMENTAL

Before the induction of anesthesia, 0.375% Ropivacaine and 5.0mg dexamethasone are used for bilateral transversus abdominis plane block in a volume of 20 mL of each side

Drug: Ropivacaine and dexamethasone

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

Ropivacaine at high concentration 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 at high concentration

Ropivacaine and dexamethasone DRUG

Before the induction of anesthesia, 0.375% Ropivacaine and 5.0mg dexamethasone are used for bilateral transversus abdominis plane block in a volume of 20 mL of each side

Also known as: Ropivacaine Hydrochloride Injection

Ropivacaine and dexamethasone

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is scheduled to undergo Laparoscopic Bariatric Surgery
• Subject's American Society of Anesthesiologists physical status is I-III.
• BMI\>35kg/m2
• The subject's parent/legally authorized guardian has given written informed consent to participate

You may not qualify if:

• Subject has a diagnosis of renal or liver failure.
• Subject has a diagnosis of mental illness
• Subject is allergy and contraindication to Ropivacaine.
• 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
• Subject is pregnant or breast-feeding.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Saline Solution; Sodium Chloride; Ropivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

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

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; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Guolin Wang, MD

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

Central Study Contacts

Guolin Wang, MD

CONTACT

+8615822855556; wangguolinhad@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: March 18, 2022
• Study Start: March 18, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 15, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share