NCT02804126

Brief Summary

Comparison of two types of analgesia after cesarean section. All patients will anaesthetised with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue 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
232

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2017

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

June 8, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

June 8, 2016

Last Update Submit

November 22, 2023

Conditions

Cesarean SectionPain ManagementNeuropathic Pain

Keywords

acute paintransversus abdominis plane blockquadratus lumborum blockneuropathic pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain measured with VAS

    Acute pain measured with VAS (visual-analogue scale).

    up to 24 hours after surgery

Secondary Outcomes (1)

  • Neuropathic pain assessed with NPSI

    6 months from the surgery

Study Arms (2)

TAP (transversus abdominis plane)

EXPERIMENTAL

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

Procedure: TAP (transversus abdominis plane block)Drug: BupivacaineDevice: NeedleDrug: ParacetamolDrug: MetamizolDrug: KetoprofenDrug: Morphine

QL (quadratus lumborum)

EXPERIMENTAL

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

Procedure: QL (quadratus lumborum block)Drug: BupivacaineDevice: NeedleDrug: ParacetamolDrug: MetamizolDrug: KetoprofenDrug: Morphine

Interventions

TAP (transversus abdominis plane block)PROCEDURE

ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).

TAP (transversus abdominis plane)
QL (quadratus lumborum block)PROCEDURE

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

QL (quadratus lumborum)
BupivacaineDRUG

In both groups (TAP\&QL) 0.25% bupivacaine will be given (0.2 mL/kg)

QL (quadratus lumborum)TAP (transversus abdominis plane)
NeedleDEVICE

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

QL (quadratus lumborum)TAP (transversus abdominis plane)
ParacetamolDRUG

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

QL (quadratus lumborum)TAP (transversus abdominis plane)
MetamizolDRUG

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

QL (quadratus lumborum)TAP (transversus abdominis plane)
KetoprofenDRUG

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

QL (quadratus lumborum)TAP (transversus abdominis plane)
MorphineDRUG

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

QL (quadratus lumborum)TAP (transversus abdominis plane)

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obtained consent
  • singleton pregnancy
  • subarachnoid anaesthesia

You may not qualify if:

  • coagulopathy
  • allergy to 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

Lublin, 20-081, Poland

Location

Related Publications (3)

  • Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.

    PMID: 24249997BACKGROUND

  • Kadam VR. Ultrasound guided quadratus lumborum block or posterior transversus abdominis plane block catheter infusion as a postoperative analgesic technique for abdominal surgery. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):130-1. doi: 10.4103/0970-9185.150575. No abstract available.

    PMID: 25788791BACKGROUND

  • Kanazi GE, Aouad MT, Abdallah FW, Khatib MI, Adham AM, Harfoush DW, Siddik-Sayyid SM. The analgesic efficacy of subarachnoid morphine in comparison with ultrasound-guided transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2010 Aug;111(2):475-81. doi: 10.1213/ANE.0b013e3181e30b9f. Epub 2010 May 20.

    PMID: 20488929BACKGROUND

MeSH Terms

Conditions

AgnosiaNeuralgiaAcute Pain

Interventions

BupivacaineNeedlesAcetaminophenDipyroneKetoprofenMorphine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesPain

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

  • Miroslaw Czuczwar, MD, PhD

    II Department of Anesthesiology and Intensive Care Medial University of Lublin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 17, 2016

Study Start

June 1, 2017

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

PL(1)