NCT04118413

Brief Summary

Erector Spinae plane block (ESPB) is a regional anesthesia technique described three years ago. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that ESPB could be efficacious for providing postoperative analgesia in the cesarean section, the investigators have implemented the application of this blockade into practice at the clinic. The main purpose of this study is to evaluate the analgesic effect of ultrasound-guided bilateral low thoracic ESPB in cesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable 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

October 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

October 14, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2019

Completed
Last Updated

December 18, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

October 5, 2019

Last Update Submit

December 17, 2019

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • 24 hours opioid consumption

    morphine consumptions for both group will be recorded

    24 hour

Secondary Outcomes (1)

  • Numeric rating scale for postoperative pain intensity

    24 hour

Study Arms (2)

Erector spinae plane block

EXPERIMENTAL

Erector spinae plane block will be administrated to this group at end of the surgery under spinal anesthesia. An intravenous patient-controlled analgesia device within morphine will be given to the patients postoperatively and sheduled paracetamol will be given.

Other: erector spinae plane block

Control Group

NO INTERVENTION

In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia with morphine and sheduled paracetamol. No block will be performed.

Interventions

erector spinae plane blockOTHER

Erector espine plane block will be administrated bilaterally to this group at low thoracic level (Th11).

Erector spinae plane block

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients undergoing cesarean section under spinal anesthesia

You may not qualify if:

  • patients undergoing cesarean section under general anesthesia morbidly obesity, ASA III - IV , infection of the skin at the site of needle puncture area, patients with known allergies to any of the study drugs, coagulopathy, recent use of analgesic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cigli regional research hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (3)

  • Yamak Altinpulluk E, Garcia Simon D, Fajardo-Perez M. Erector spinae plane block for analgesia after lower segment caesarean section: Case report. Rev Esp Anestesiol Reanim (Engl Ed). 2018 May;65(5):284-286. doi: 10.1016/j.redar.2017.11.006. Epub 2018 Jan 17. English, Spanish.

    PMID: 29352577RESULT

  • Santonastaso DP, de Chiara A, Addis A, Mastronardi C, Pini R, Agnoletti V. Ultrasound guided erector spinae plane block for post-operative pain control after caesarean section. J Clin Anesth. 2019 Dec;58:45-46. doi: 10.1016/j.jclinane.2019.05.009. Epub 2019 May 7. No abstract available.

    PMID: 31075624RESULT

  • Aygun H, Thomas DT, Tulgar S. Comment to Santonastaso et al. 'J Clin Anesth 2019; 58: 45-46' and report of erector spinae plane block series in caesarean delivery patients. J Clin Anesth. 2020 Mar;60:4-5. doi: 10.1016/j.jclinane.2019.08.008. Epub 2019 Aug 16. No abstract available.

    PMID: 31425897RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aygun

    izmir cigli regional hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator,

Study Record Dates

First Submitted

October 5, 2019

First Posted

October 8, 2019

Study Start

October 14, 2019

Primary Completion

December 17, 2019

Study Completion

December 17, 2019

Last Updated

December 18, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)