The Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Comparison With Intrathecal Morphine After Elective Cesarean Section

NCT03935412 | Completed

• 1 other identifier: R 125
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to assess the analgesic efficacy of bilateral erector spinae plane block in comparison with intrathecal morphine after elective cesarean section under spinal anesthesia.

Conditions

Postoperative Pain

Keywords

Erector spinae plane block; morphine; cesarean section; postoperative analgesia; spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• the severity of pain: VAS

  VAS

  8 hour

Secondary Outcomes (8)

• the total analgesic consumption

  24 hour

• the severity of pain: VAS

  immediately in PACU

• the severity of pain: VAS

  4 hours

• the severity of pain: VAS

  12 hours

• the severity of pain: VAS

  16 hours

Study Arms (2)

ES Erector Spinae Plane Block

ACTIVE COMPARATOR

By the end of surgery parturient in the ESPB underwent bilateral ESPB at the level of T9 using a linear ultrasound (US) transducer (Phillips Saronno Italy) the transducer was placed vertically3cm lateral to the midline to visualize the muscles of the back, transverse process and the pleura in between the two transverse processes. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine 22-G short bevel needle (spinocan, B.Braun melsungen AG, Germany) was inserted in cranial-caudal direction towards the transvers process using in plane technique until the needle cross all the muscles then interfascial injection of 20ml 0.5% bupivacaine was done after ensuring negative aspiration, the procedure was repeated following the same steps on the other side of the back.

Procedure: Erector Spinae Plane Block

intrathecal morphine ITM

SHAM COMPARATOR

participant in the ITM group intrathecal injection of 10mg of hyperbaric bupivacaine 0.5 % in addition to 100 mcg of preservative-free morphine. Then, the parturient immediately placed in the supine position with 15° left tilt, and an oxygen mask was applied at 2 l.min-1. After ensuring sufficient anesthesia level, the surgical procedure was done with continuous hemodynamics monitoring and recording. While participants in the ITM group underwent sham blocks; Sham blocks consisted of a non-invasive ultrasound scan, while a blunt needle was gently pressed on both sides.

Procedure: Erector Spinae Plane Block

Interventions

Erector Spinae Plane Block PROCEDURE

Erector Spinae Plane Block

ES Erector Spinae Plane Block; intrathecal morphine ITM

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status (ASA) class Ι, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation

You may not qualify if:

• included significant hepatic, renal or cardiovascular diseases, local infection, bleeding disorders, any contraindication to intrathecal anesthesia and parturient had a known allergy to the study drugs.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Faculty of Medicine

Al Fayyum, 63511, Egypt

Location

Related Publications (2)

• Ueshima H, Otake H. Similarities Between the Retrolaminar and Erector Spinae Plane Blocks. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):123-124. doi: 10.1097/AAP.0000000000000526. No abstract available.

  PMID: 27997492 BACKGROUND

• Leung AY. Postoperative pain management in obstetric anesthesia--new challenges and solutions. J Clin Anesth. 2004 Feb;16(1):57-65. doi: 10.1016/j.jclinane.2003.02.012.

  PMID: 14984863 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: mohamed ahmed hamed

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: May 2, 2019
• Study Start: March 5, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 5, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

EG (1)