Back to results

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

Primary Purpose

Nausea and Vomiting, Laparoscopic Bariatric Surgery

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Ropivacaine

About this trial

This is an interventional prevention trial for Nausea and Vomiting

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tianjin Medical University General HospitalRecruiting
Zhen JiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Normal Saline

Ropivacaine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative nausea and vomiting

Secondary Outcome Measures

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

Time of First Postoperative Analgesic Requirement

First postoperative pain (NRS≥4) is initially controlled by titration of sufentanyl

Occurrence of Side Effects

Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus

Total Dose of First Postoperative Analgesic Requirement

First postoperative pain (NRS≥4) is initially controlled by titration of sufentanyl.

Full Information

NCT ID

NCT05016180

First Posted

June 30, 2021

Last Updated

August 16, 2021

Sponsor

Tianjin Medical University General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05016180

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 25, 2020 (Actual)

Primary Completion Date

November 26, 2021 (Anticipated)

Study Completion Date

December 25, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tianjin Medical University General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea and Vomiting, Laparoscopic Bariatric Surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Normal Saline

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Ropivacaine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ropivacaine

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative nausea and vomiting

Description

Postoperative nausea and vomiting

Time Frame

72 hours after surgery

Secondary Outcome Measure Information:

Title

Cumulative Sufentanyl Consumption

Description

Time Frame

24 hours after surgery

Title

Time of First Postoperative Analgesic Requirement

Description

First postoperative pain (NRS≥4) is initially controlled by titration of sufentanyl

Time Frame

1 hour after surgery

Title

Occurrence of Side Effects

Description

Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus

Time Frame

24 hours after surgery

Title

Total Dose of First Postoperative Analgesic Requirement

Description

First postoperative pain (NRS≥4) is initially controlled by titration of sufentanyl.

Time Frame

1 hour after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhen Jia, MD

Phone

13002211205

1464322162@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guolin Wang, MD

Organizational Affiliation

Tianjin Medical University General Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Tianjin Medical University General Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300052

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guolin Wang, M.D., Ph. D.

Phone

86-22-60362606

wang_guolin@hotmail.com

First Name & Middle Initial & Last Name & Degree

Guolin Wang, M.D PHD

Facility Name

Zhen Jia

City

Tianjin

State/Province

Tianjin

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jia Zhen, MD

Phone

13002211205

1464322162@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs