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

Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05016180
• Other study ID #: IRB2020-YX-083-01
• Status: Recruiting
• Phase: Phase 2
• Start date: September 25, 2020
• Est. completion date: December 25, 2021

Study information

• Verified date: August 2021
• Source: Tianjin Medical University General Hospital
• Contact: Zhen Jia, MD
• Phone: 13002211205
• Email: 1464322162[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 25, 2021
• Est. primary completion date: November 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Subject is scheduled to undergo Laparoscopic Bariatric Surgery

2. Subject's American Society of Anesthesiologists physical status is I-III.

3. BMI>35kg/m2

4. The subject's parent/legally authorized guardian has given written informed consent to participate

Exclusion Criteria:

1. Subject has a diagnosis of renal or liver failure.

2. Subject has a diagnosis of mental illness

3. Subject is allergy and contraindication to Ropivacaine.

4. 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.

5. Subject has any contraindication for the use of patient-controlled analgesia (PCA).

6. Subject is pregnant or breast-feeding.

Related Conditions & MeSH terms

• Laparoscopic Bariatric Surgery
• Nausea
• Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Zhen Jia	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative nausea and vomiting	Postoperative nausea and vomiting	72 hours after surgery
Secondary	Cumulative Sufentanyl Consumption	Each patient was administered analgesics using a PCA pump containing sufentanil (100µg) in normal saline at a total volume of 100 ml after leaving PACU. This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperatively	24 hours after surgery
Secondary	Time of First Postoperative Analgesic Requirement	First postoperative pain (NRS=4) is initially controlled by titration of sufentanyl	1 hour after surgery
Secondary	Occurrence of Side Effects	Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus	24 hours after surgery
Secondary	Total Dose of First Postoperative Analgesic Requirement	First postoperative pain (NRS=4) is initially controlled by titration of sufentanyl.	1 hour after surgery