NCT04938882

Brief Summary

Purpose: To explore effects of ultrasound-guided transversus abdominis plane block with compound lidocaine on postoperative pain after gynecological laparotomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2022

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

June 22, 2021

Last Update Submit

February 21, 2022

Conditions

Postoperative Pain

Keywords

Compound lidocaineRopivacainepain intensityTransversus abdominis plane block

Outcome Measures

Primary Outcomes (1)

  • Pain Score (NRS)

    The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.

    72 hours after surgery

Secondary Outcomes (9)

  • Time of First Postoperative Analgesic Requirement

    1 hour after surgery

  • Total Dose of First Postoperative Analgesic Requirement

    1 hour after surgery

  • Cumulative Sufentanyl Consumption

    72 hours after surgery

  • Occurrence of Side Effects

    72 hours after surgery

  • Normalized Area of Hyperalgesia Around the Incision

    72 hours after surgery

  • +4 more secondary outcomes

Study Arms (4)

Normal saline in transversus abdominis plane block

PLACEBO COMPARATOR

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

Drug: Normal saline

Ropivacaine in transversus abdominis plane block

ACTIVE COMPARATOR

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

Drug: Ropivacaine

Compound lidocaine at low-concentration in transversus abdominis plane block

ACTIVE COMPARATOR

Before the induction of anesthesia, 0.4% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side

Drug: Compound lidocaine at low concentration

Compound lidocaine at high-concentration in transversus abdominis plane block

ACTIVE COMPARATOR

Before the induction of anesthesia, 0.6% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side

Drug: Compound lidocaine at high concentration

Interventions

Normal salineDRUG

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

Also known as: 0. 9% Sodium Chloride Injection
Normal saline in transversus abdominis plane block
RopivacaineDRUG

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

Also known as: Ropivacaine Hydrochloride Injection
Ropivacaine in transversus abdominis plane block
Compound lidocaine at low concentrationDRUG

Before the induction of anesthesia, 0.4% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side

Also known as: Compound Hydrochloride Lidocaine Injection
Compound lidocaine at low-concentration in transversus abdominis plane block
Compound lidocaine at high concentrationDRUG

Before the induction of anesthesia, 0.6% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side

Also known as: Compound Hydrochloride Lidocaine Injection
Compound lidocaine at high-concentration in transversus abdominis plane block

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is scheduled to undergo gynecological laparotomy under general anesthesia
  • Subject's American Society of Anesthesiologists physical status is I-II.
  • The subject's parent/legally authorized guardian has given written informed consent to participate.

You may not qualify if:

  • Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure.
  • Subject has a diagnosis of Insulin dependent diabetes.
  • Subject is allergy and contraindication to local anesthetics or any components of local anesthetics.
  • 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.
  • Subject is obese (body mass index \>30kg/m\^2).
  • Subject is incapacity to comprehend pain assessment and cognitive assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Related Publications (3)

  • Tran DQ, Bravo D, Leurcharusmee P, Neal JM. Transversus Abdominis Plane Block: A Narrative Review. Anesthesiology. 2019 Nov;131(5):1166-1190. doi: 10.1097/ALN.0000000000002842.

    PMID: 31283738BACKGROUND

  • Ma N, Duncan JK, Scarfe AJ, Schuhmann S, Cameron AL. Clinical safety and effectiveness of transversus abdominis plane (TAP) block in post-operative analgesia: a systematic review and meta-analysis. J Anesth. 2017 Jun;31(3):432-452. doi: 10.1007/s00540-017-2323-5. Epub 2017 Mar 7.

    PMID: 28271227BACKGROUND

  • Zhang L, Jia Z, Gao T, Wang Y, Zhao Y, Li J, Yu Y, Li Q, Wang G. A randomized controlled trial evaluating the effects of transversus abdominis plane block with compound lidocaine hydrochloride injection on postoperative pain and opioid consumption and gastrointestinal motility in patients undergoing gynecological laparotomy. Front Mol Neurosci. 2023 Jan 25;16:967917. doi: 10.3389/fnmol.2023.967917. eCollection 2023.

    PMID: 36760605DERIVED

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

Saline SolutionSodium ChlorideRopivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Guolin Wang, MD

    Tianjin Medical University General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 24, 2021

Study Start

August 15, 2021

Primary Completion

February 10, 2022

Study Completion

February 14, 2022

Last Updated

February 23, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)