NCT03404908

Brief Summary

Comparison of two types of analgesia after cesarean section All patients will be anesthetized with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will be measured with visual-analog scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2018

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

First Submitted

Initial submission to the registry

January 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

February 7, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2019

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

January 12, 2018

Last Update Submit

November 22, 2023

Conditions

Cesarean SectionPostoperative Pain

Keywords

transversus abdominis plane blockquadratus lumborum blockneuropathic pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    Acute pain measured with VAS (visual-analogue scale). VAS in milimmeters. Minimum value 0, maximum 100. Less better - less severe pain. 0 no pain at all.

    up to 24 hours after the surgery

Secondary Outcomes (1)

  • Neuropathic pain

    6 months from the surgery

Study Arms (2)

TAP

EXPERIMENTAL

Ultrasound-guided transversus abdominis plane block at the end of cesarean section

Procedure: TAP (transversus abdominis plane block)Drug: RopivacaineDevice: NeedleDrug: paracetamolDrug: metamizoleDrug: KetoprofenDrug: Morphine

QLB

EXPERIMENTAL

Ultrasound-guided quadratus lumborum block at the end of cesarean section

Procedure: QL (quadratus lumborum block)Drug: RopivacaineDevice: NeedleDrug: paracetamolDrug: metamizoleDrug: KetoprofenDrug: Morphine

Interventions

TAP (transversus abdominis plane block)PROCEDURE

the ultrasound-guided regional block of abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375% ropivacaine administered (0.2 mL/kg).

TAP
QL (quadratus lumborum block)PROCEDURE

the ultrasound-guided regional block of abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with a distribution of local anesthetic towards paravertebral space. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).

QLB
RopivacaineDRUG

In both groups (TAP\&QLB) 0.375% ropivacaine will be given (0.2 mL/kg)

QLBTAP
NeedleDEVICE

Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study

QLBTAP
paracetamolDRUG

Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day

QLBTAP
metamizoleDRUG

Intravenous metamizole will be used (1.0 gram), up to 4 grams per day

QLBTAP
KetoprofenDRUG

Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day

QLBTAP
MorphineDRUG

Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)

QLBTAP

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsparturients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obtained consent
  • singleton pregnancy
  • subarachnoid anesthesia

You may not qualify if:

  • coagulopathy
  • allergy to local anesthetics
  • depression, antidepressant drugs treatment
  • epilepsy
  • usage of painkiller before surgery
  • addiction to alcohol or recreational drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

II Department of Anesthesia and Intensive Care, Medical University of Lublin

Lublin, 20-081, Poland

Location

MeSH Terms

Conditions

Pain, PostoperativeNeuralgia

Interventions

RopivacaineNeedlesAcetaminophenDipyroneKetoprofenMorphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEquipment and SuppliesAcetanilidesAminopyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Mirosław Czuczwar, M.D., PhD

    Medical University of Lublin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 19, 2018

Study Start

February 7, 2018

Primary Completion

January 14, 2019

Study Completion

April 17, 2019

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)