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Clinical Trials/NCT05286008
NCT05286008
Unknown
Not Applicable

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 Hospital0 sites90 target enrollmentMarch 18, 2022

Overview

Phase
Not Applicable
Intervention
Normal saline
Conditions
Postoperative Nausea and Vomiting
Sponsor
Tianjin Medical University General Hospital
Enrollment
90
Primary Endpoint
Postoperative nausea and vomiting
Last Updated
4 years ago

Overview

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

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, investigators will evaluate the efficacy of ultrasound-guided transversus abdominis plane(USG- TAP) block with ropivacaine in Laparoscopic Bariatric Surgery.

Registry
clinicaltrials.gov
Start Date
March 18, 2022
End Date
October 15, 2022
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
  • 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: Normal saline

Ropivacaine at high concentration

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

Intervention: Ropivacaine at high concentration

Ropivacaine and dexamethasone

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

Intervention: Ropivacaine and dexamethasone

Outcomes

Primary Outcomes

Postoperative nausea and vomiting

Time Frame: 72 hours after surgery

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

Secondary Outcomes

  • cumulative Sufentanyl Consumption during surgery(during surgery)
  • Mean time until passage of flatus(72 hours after surgery)
  • Diffusion area of local anesthetics after transversus abdominis plane block(30 minutes after transversus abdominis plane block)
  • Time of First Postoperative Analgesic Requiremen(1hour after surgery)
  • Apfel score(The 1 day before the surgery)
  • The incidence of Side Effects(48 hours after surgery)
  • Total Dose of First Postoperative Analgesic Requirement(1hour after surgery)
  • cumulative Sufentanyl Consumption after surgery(48 hours after surgery)
  • Time to ambulation(12 hours after surgery)
  • Normalized Area of Hyperalgesia Around the Incision(48 hours after surgery)

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