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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05286008
Enrollment
90
Registered
2022-03-18
Start date
2022-03-18
Completion date
2022-10-15
Last updated
2022-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting, Postoperative Pain

Keywords

Ropivacaine, Transversus abdominis plane block, opioid consumption, Dexamethasone

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.

Interventions

DRUGNormal 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

DRUGRopivacaine 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

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

Sponsors

Tianjin Medical University General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Double (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative nausea and vomiting72 hours after surgeryThe Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).

Secondary

MeasureTime frameDescription
cumulative Sufentanyl Consumption after surgery48 hours after surgeryEach patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a totalvolume of 100 ml after leaving PACU. This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperative
Time of First Postoperative Analgesic Requiremen1hour after surgeryFirst postoperative pain (NRS≥5) is initially controlled by titration of sufentany
Total Dose of First Postoperative Analgesic Requirement1hour after surgeryFirst postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
The incidence of Side Effects48 hours after surgeryThe number of patients with side effects including nausea, vomiting, dizziness, headache, shivering, and pruritus is recorded for 48 hours postoperatively
cumulative Sufentanyl Consumption during surgeryduring surgeryEach patient was administered sufentanil for analgesic during surgery
Time to ambulation12 hours after surgeryThe obesity's time to ambulation after surge
Mean time until passage of flatus72 hours after surgeryGastrointestinal motility was evaluated by recording mean time until passage of flatus
Diffusion area of local anesthetics after transversus abdominis plane block30 minutes after transversus abdominis plane blockDiffusion area of local anesthetics after transversus abdominis plane block was calculated under ultrasound assistance.
Normalized Area of Hyperalgesia Around the Incision48 hours after surgeryThe skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper'feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.
Apfel scoreThe 1 day before the surgeryThe Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).

Contacts

Primary ContactGuolin Wang, MD
wangguolinhad@hotmail.com+8615822855556

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026