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Clinical Trials/NCT05016180
NCT05016180
Unknown
Phase 2

Impact of Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Nausea and Vomiting and Early Outcome After Laparoscopic Bariatric Surgery: a Randomized Double-Blinded Controlled Trial

Tianjin Medical University General Hospital2 sites in 1 country120 target enrollmentSeptember 25, 2020

Overview

Phase
Phase 2
Intervention
Ropivacaine
Conditions
Nausea and Vomiting
Sponsor
Tianjin Medical University General Hospital
Enrollment
120
Locations
2
Primary Endpoint
Postoperative nausea and vomiting
Last Updated
4 years ago

Overview

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

Detailed Description

Poor postoperative nausea and vomiting control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. Recently, the multimodal analgesia strategies to minimise opioid-related side effects are highly desirable in open surgical procedures. The transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. Although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. Herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (USG-TAP) block with ropivacaine in Laparoscopic Bariatric Surgery

Registry
clinicaltrials.gov
Start Date
September 25, 2020
End Date
December 25, 2021
Last Updated
4 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 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

Exclusion Criteria

  • 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.

Arms & Interventions

Normal Saline

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

Intervention: Ropivacaine

Ropivacaine

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

Intervention: Ropivacaine

Outcomes

Primary Outcomes

Postoperative nausea and vomiting

Time Frame: 72 hours after surgery

Postoperative nausea and vomiting

Secondary Outcomes

  • 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 Sites (2)

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