Bilateral Erector Spinae Plane Block After Elective Cesarean Section

NCT04016688 | Completed

• 1 other identifier: R 126
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of work is to assess and compare the analgesic efficacy of bilateral erector spinae plane block with that of bilateral transversus abdominis plane block after elective cesarean section.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• duration of analgesia of the two blocks

  time

  24 hours

Secondary Outcomes (7)

• Visual analogue scale

  immediatiy in pacu

• Visual analogue scale

  4 hours

• Visual analogue scale

  8 hours

• Visual analogue scale

  12 hours

• Visual analogue scale

  24 hours

Study Arms (2)

ES Erector Spinae Plane Block

ACTIVE COMPARATOR

bilateral ESP block at the level of T9 by a linear ultrasound (US) transducer (Phillips Saronno Italy) placed vertically 3cm lateral to the midline to visualize the back muscles superior to the transverse process. A 22-G short bevel needle (spinocan, B.Braun, melsungen AG, Germany) will be inserted in cranial-caudal direction until it make contact with the transverse process. Confirmation of the correct position of the tip of the needle is by injection of 1 ml saline causing hydrodisscetion between the erector spinae muscle and the transverse process. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine is injected.The same procedure is done on the other side of the back.

Procedure: ESPB and TAP block

TAP Transversus Abdominis Plane Block

ACTIVE COMPARATOR

bilateral TAP block: while the patient in the supine position, a linear ultrasound (US) transducer (Phillips Saronno Italy) is placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis. A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) is introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine is injected causing an elliptical separation of the two muscles. The same procedure is done on the other side.

Procedure: ESPB and TAP block

Interventions

ESPB and TAP block PROCEDURE

bilateral TAP block: while the patient in the supine position, a linear ultrasound (US) transducer (Phillips Saronno Italy) is placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis. A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) is introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.5 % bupivacaine is injected causing an elliptical separation of the two muscles. The same procedure is done on the other side.

ES Erector Spinae Plane Block; TAP Transversus Abdominis Plane Block

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: 18 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18 - 40 years
• American Society of Anesthesiologists physical status ІІ, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation.

You may not qualify if:

• Patient refusal.
• Contraindications to regional anesthesia.
• Known allergy to the study drugs.
• Severe cardiovascular, renal or hepatic diseases.
• Bleeding disorders.
• Local infection.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (3)

Faculty of Medicine

Al Fayyum, 63511, Egypt

Location

Mohamed Hamed

Al Fayyum, 63511, Egypt

Location

Mohamed

Al Fayyum, 65345, 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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia lecturer

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 11, 2019
• Study Start: July 8, 2019
• Primary Completion: December 31, 2019
• Study Completion: January 1, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)