Ultrasound Guided Bilateral Erector Spinae Plane Block in Caesarean Delivery

Pain Clinical Trial

Official title:

Bilateral Ultrasound Guided Low Thoracic Erector Spinae Plane Block for Postoperative Analgesia in Caesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118413
• Other study ID #: ESPB for CD
• Status: Completed
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: December 17, 2019

Study information

• Verified date: December 2019
• Source: Cigli Regional Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• erector spinae plane block
Erector espine plane block will be administrated bilaterally to this group at low thoracic level (Th11).

Locations

Country	Name	City	State
Turkey	Cigli regional research hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Cigli Regional Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 — View Citation

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 20 — View Citation

Yamak Altinpulluk E, García Simón D, Fajardo-Pérez M. Erector spinae plane block for analgesia after lower segment caesarean section: Case report. Rev Esp Anestesiol Reanim. 2018 May;65(5):284-286. doi: 10.1016/j.redar.2017.11.006. Epub 2018 Jan 17. Engli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hours opioid consumption	morphine consumptions for both group will be recorded	24 hour
Secondary	Numeric rating scale for postoperative pain intensity	Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	24 hour