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Ultrasound Guided Bilateral Erector Spinae Plane Block in Caesarean Delivery

NCT ID: NCT04118413

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2019-12-17

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Erector spinae plane block

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.

Group Type EXPERIMENTAL

erector spinae plane block

Intervention Type OTHER

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

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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erector spinae plane block

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients undergoing cesarean section under spinal anesthesia

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cigli Regional Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hakan Aygün

Principal Investigator,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aygun

Role: PRINCIPAL_INVESTIGATOR

izmir cigli regional hospital

Locations

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Cigli regional research hospital

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 29352577 (View on PubMed)

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.

Reference Type RESULT
PMID: 31075624 (View on PubMed)

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.

Reference Type RESULT
PMID: 31425897 (View on PubMed)

Other Identifiers

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ESPB for CD

Identifier Type: -

Identifier Source: org_study_id