NCT03634111

Brief Summary

The transversus abdominis plane block (TAP block) has effect to postoperative analgesia for cesarean section with spinal anesthesia but it was limited for cesarean section with general anesthesia. The hypothesis that this technique has effect to postoperative analgesia for cesarean section with general anesthesia and it could reduce 50% of total morphine consumption during 24 hours after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2017

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

5 days

First QC Date

August 12, 2018

Last Update Submit

August 14, 2018

Conditions

Obstetric Pain

Keywords

transversus abdominis plane block (TAP block)postoperative analgesiacesarean section

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption during 24 hours

    Morphine was intravenous perfusion to participants during 24 hours with patients controlled analgesia (PCA).

    24 hours

Secondary Outcomes (5)

  • The time required the first of dose of morphine (hours)

    24 hours

  • Pain score: VAS

    24 hours

  • The rate of complications of TAP block

    24 hours

  • The rate of side effect of morphine

    24 hours

  • The satisfaction of participants: Likert

    24 hours

Study Arms (2)

T group

ACTIVE COMPARATOR

The TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery.

Procedure: TAP blockDrug: MorphineDrug: Ropivacaine

C group

PLACEBO COMPARATOR

The controlled group was called C group. The participants has not TAP block and were treated postoperative analgesia with intravenous morphine to patients controlled analgesia

Drug: MorphineDrug: Ropivacaine

Interventions

TAP blockPROCEDURE

TAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.

Also known as: Transversus abdominis plane block
T group
MorphineDRUG

Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.

Also known as: Opioids
C groupT group
RopivacaineDRUG

Ropivacaine 0.25% 20 ml each side

Also known as: Anaropin
C groupT group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Cesarean section with general anesthesia.
  • The ASA classification was from II to III

You may not qualify if:

  • The acute fetal impairment.
  • The severe live or renal failure.
  • Tolerance opioids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

THANG Nguyen Trong

Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Labor Pain

Interventions

MorphineAnalgesics, OpioidRopivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsNarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • THANG T Nguyen, Mr

    Gia Dinh People Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants were cesarean section with general anesthesia
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Transversus abdominis plane block under the ultrasound guidance
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2018

First Posted

August 16, 2018

Study Start

July 10, 2017

Primary Completion

July 15, 2017

Study Completion

March 31, 2018

Last Updated

August 16, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)