NCT04172727

Brief Summary

Postoperative pain management is critical for the fulfillment of the maternal duties. The transversalis fascia plane (TFP) block provides adequate postoperative analgesia in the T12 and L1 dermatomes. The aim of this study was to investigate the effect of the TFP block on postoperative opioid consumption and pain scores in patients undergoing cesarean section (CS) under spinal anesthesia.

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 phase_4

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

January 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

November 20, 2019

Last Update Submit

November 20, 2019

Conditions

Caesarean SectionPain, Acute

Outcome Measures

Primary Outcomes (1)

  • opioid consumption

    morphine consumption first 24hour

    Postoperative first 24hour

Secondary Outcomes (1)

  • pain scores

    postoperative 0-24 hours

Study Arms (2)

ultrasound guided transversalis fascia plane block

ACTIVE COMPARATOR

20 mL of 0.25% bupivacaine

Drug: Bupivacaine Hcl 0.25% Inj

ultrasound guided sham block

PLACEBO COMPARATOR

20 mL of saline

Drug: saline 0.9%

Interventions

Bupivacaine Hcl 0.25% InjDRUG

ultrasound-guided bilateral TFP block with 20 mL of 0.25% bupivacaine

ultrasound guided transversalis fascia plane block
saline 0.9%DRUG

ultrasound-guided bilateral TFP block with 20 mL of saline 0.9%

ultrasound guided sham block

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen aged between 18 and 45 with American Society of Anesthesiologists (ASA) physical score I or II undergoing elective CS
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged between 18 and 45
  • American Society of Anesthesiologists (ASA) physical score I or II

You may not qualify if:

  • Patients who received general anesthesia
  • hypersensitivity to the agents to be used
  • body mass index (BMI) greater than 35 kg/m2
  • coagulopathy
  • local infections
  • opioid addiction
  • pregnancy-related hypertension or diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ali Ahıskalıoğlu

Erzurum, 25100, Turkey (Türkiye)

Location

Related Publications (3)

  • Serifsoy TE, Tulgar S, Selvi O, Senturk O, Ilter E, Peker BH, Ozer Z. Evaluation of ultrasound-guided transversalis fascia plane block for postoperative analgesia in cesarean section: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2020 Feb;59:56-60. doi: 10.1016/j.jclinane.2019.06.025. Epub 2019 Jun 27.

    PMID: 31255890BACKGROUND

  • Hebbard PD. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anaesth. 2009 Aug;56(8):618-20. doi: 10.1007/s12630-009-9110-1. Epub 2009 Jun 4. No abstract available.

    PMID: 19495909BACKGROUND

  • Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.

    PMID: 32412986DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

BupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 21, 2019

Study Start

January 1, 2019

Primary Completion

May 1, 2019

Study Completion

June 1, 2019

Last Updated

November 21, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)