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

NCT ID: NCT05286008

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-18
• Study Completion Date: 2022-10-15

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.

Conditions

Postoperative Nausea and Vomiting; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Ropivacaine at high concentration

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Ropivacaine and dexamethasone

Intervention Type: 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

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 Type: DRUG

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 Type: DRUG

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 Type: DRUG

Other Intervention Names

0. 9% Sodium Chloride Injection; Ropivacaine Hydrochloride Injection; Ropivacaine Hydrochloride Injection

Eligibility Criteria

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

6. Subject is pregnant or breast-feeding.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guolin Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guolin Wang, MD

Role: STUDY_DIRECTOR

Tianjin Medical University General Hospital

Central Contacts

Guolin Wang, MD

Role: CONTACT

wangguolinhad@hotmail.com

+8615822855556

Other Identifiers

GWang022

Identifier Type: -

Identifier Source: org_study_id