The Effect of Bilateral Erector Spina Plane Block on Postoperative Analgesia in Cesarean Section Under SpinalAnaesthesia

Pain, Postoperative Clinical Trial

Official title:

The Effect of Bilateral Erector Spina Plane Block on Postoperative Analgesia in Cesarean Section Under Spinal Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05695625
• Other study ID #: AnkaraU-CS-ESPB
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: January 2023
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute pain after cesarean section (SC) can be variable. Untreated pain can affect patients' life quality. Currently regional nerve blocks are frequently used as a part of multimodal analgesia. Erector spina plane block (ESPB), a recently defined interfacial plane block, provides multisegmental analgesia by spreading to both ventral and dorsal branches of the spinal nerve roots in the cranio-caudal plane with a single injection. The aim of this study is to evaluate the effects of ESPB on postoperative pain, analgesic use and patient satisfaction in patients delivered by CS under spinal anesthesia.

Description:

Cesarean section (CS) is one of the most common surgical procedures in the world. Acute pain intensity after cesarean section can be variable, making difficult to predict pain severity. Untreated pain can affect patients' life quality. Currently regional nerve blocks are frequently used as a part of multimodal analgesia. Erector spina plane block (ESPB) is a recently defined interfascial plane block. As a result of ultrasound (USG) guided local anesthetic drug injection into the fascial plane between erector spina muscle and vertebral transverse process, multisegmental analgesia provided by spreading to the both ventral and dorsal branches of the spinal nerve roots in cranio-caudal plane with a single injection. The primary aim of this study was to evaluate the effects of bilateral ESPB on postoperative pain, using the visual analog scale (VAS) in patients delivered by CS under spinal anesthesia. The secondary aims of the study are to evaluate the effects of ESPB on analgesic drug use and patient satisfaction in the postoperative period.

116 pregnants, aged between 18-45 years, delivered by CS from May 2020 to June 2021 included the prospective, randomised, single centre study. Exclusion criteria were age under 18 years, over 45 years, body mass index (BMI) over 35 kg/m2, ASA status over III, multiple pregnancy, preeclampsia, bleeding diathesis, opioid use and allergy to drugs to be used in the study. Spinal anesthesia was administered with 0.5% bupivacaine and fentanyl 12.5mcg at the level of L4-5 interspace with 26G quincke spinal needle in the sitting position. At the end of the surgery, in ESPB group, patients were given a sitting position with the help of 2 people for USG-guided ESPB. The high-frequency linear USG probe was placed in the midline at T12 level, after the spinous process visualized, the transverse process was visualized by moving probe 3-4cm laterally. After confirming the location of the needle tip with 1-2ml hydrodissection, 10 ml bupivacaine + 10 ml salin was applied both right and left sides. At the postoperative 2, 4, 6, 12 and 24th hours, patients' rest, cough, movement, low back and headache VAS values, analgesic drug use, first analgesic use time and satisfaction were evaluated. ESPB spread level was evaluated with pin-prick at the 4-6th hours. The SPSS 11.5 program was used for statistical analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 1, 2022
• Est. primary completion date: June 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• between 18-45 years, pregnants delivered by CS from May 2020 to June 2021

Exclusion Criteria:

• age under 18 years, over 45 years, body mass index (BMI) over 35 kg/m2, ASA status over III, multiple pregnancy, preeclampsia, bleeding diathesis, opioid use and allergy to drugs to be used in the study

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Other:
• Spinal anesthesia + bilateral erector spine plane block
Intraoperative period: Spinal anesthesia was administered with 0.5% bupivacaine and fentanyl 12.5mcg at the level of L4-5 interspace in the sitting position. At the end of the surgery, patients were given a sitting position with the help of 2 people for USG-guided ESPB. The high-frequency linear USG probe was placed in the midline at T12 level, after the spinous process visualized, the transverse process was visualized by moving probe 3-4cm laterally. After confirming the location of the needle tip with 1-2ml hydrodissection, 10 ml bupivacaine + 10 ml salin was applied both right and left sides. Postoperative period: If patients' VAS value >4, 75mg diclofenac intramuscular was administered. After 30 mins if patients' VAS values >4, 1000mg paracetamol intravenously was administered.
• Spinal anesthesia
Intraoperative period: Spinal anesthesia was administered with 0.5% bupivacaine and fentanyl 12.5mcg at the level of L4-5 interspace in the sitting position. Postoperative period: If patients' VAS value >4, 75mg diclofenac intramuscular was administered. After 30 mins if patients' VAS values >4, 1000mg paracetamol intravenously was administered.

Locations

Country	Name	City	State
Turkey	Bengi Safak	Ankara

Sponsors (6)

Lead Sponsor	Collaborator
Ankara University	Ahmet Onat Bermede, Bulut Varli, Hanife Asuman Uysalel, Süheyla Karadag Erkoç, Volkan Baytas

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	VAS scores at 2, 4, 6, 12 and 24th hours. (VAS is an 11 point numeric scale ranges from 0 to 10. )	24 hours
Secondary	Postoperative analgesic drug consumption	Diclofenac consumption in the first 24 hours was measured.	24 hours
Secondary	Need for rescue analgesic	The number of patients who required rescue analgesic in the first 24 hours and paracetamol consumption were recorded.	24 hours
Secondary	Number of patients with postoperative nausea-vomiting and need of antiemetic usage	Number of patients with postoperative nausea-vomiting and need of antiemetic usage were recorded.	24 hours
Secondary	Patients' satisfaction	At the postoperative 2, 4, 6, 12 and 24th hours patients' satisfaction was assessed using a descriptive verbal scale (11 point scale from 0 to 10. 0: not satisfied, 10: very satisfied).	24 hours
Secondary	First analgesic using time, first mobilization time, hospitalization time	Postoperative first analgesic using time, first mobilization time and hospitalization time were recorded.	Postoperative 4 days on an average
Secondary	ESPB spread level	The range of sensory block level in ESPB group was evaluated as dermatomal after the effect of spinal anesthesia passed, at 4-6th hours with pin-prick test.	4-6th hours