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

NCT05016180 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: IRB2020-YX-083-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Purpose: 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

Nausea and Vomiting; Laparoscopic Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative nausea and vomiting

  Postoperative nausea and vomiting

  72 hours after surgery

Secondary Outcomes (4)

• Cumulative Sufentanyl Consumption

  24 hours after surgery

• Time of First Postoperative Analgesic Requirement

  1 hour after surgery

• Occurrence of Side Effects

  24 hours after surgery

• Total Dose of First Postoperative Analgesic Requirement

  1 hour after surgery

Study Arms (2)

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: Ropivacaine

Ropivacaine

EXPERIMENTAL

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

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

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

Normal Saline; Ropivacaine

Eligibility Criteria

• Age: 18 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 of patient-controlled analgesia (PCA).
• Subject is pregnant or breast-feeding.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (2)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

Zhen Jia

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Guolin Wang, MD

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

Central Study Contacts

Zhen Jia, MD

CONTACT

13002211205; 1464322162@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: June 30, 2021
• First Posted: August 23, 2021
• Study Start: September 25, 2020
• Primary Completion: November 26, 2021
• Study Completion: December 25, 2021
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

CN (2)