Comparison of Ultrasound-Guided Bilateral Erector Spinae Plane Block Versus Bilateral Rectus Sheath Block in Adults Undergoing Major Abdominal Surgery

NCT04229420 | Completed

• 1 other identifier: MD-33-2019
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, controlled study is designed to assess the quality of analgesia provided by ultrasound guided ESPB versus RSB in adults undergoing major abdominal surgery.

Conditions

Pain; Postoperative

Keywords

erector spinae; ultrasound; rectus sheath; pain

Outcome Measures

Primary Outcomes (1)

• Time to first request of postoperative rescue analgesics

  the time interval between the block performance and the first request to postoperative analgesia and or VAS ≥ 4

  24 hours

Secondary Outcomes (5)

• Visual analogue score at rest (static), and on movement or coughing (dynamic)

  24 hours

• Total consumption of morphine

  24 hours

• Incidence of perioperative complications.

  24 hours

• Block performance time in min

  procedure (time from probe contact with skin till needle withdrawal)

• Failure rate of the block

  1st postoperative hour

Study Arms (2)

Rectus sheath block group (RSB)

ACTIVE COMPARATOR

After preparing the skin, a high frequency (5-10 MHz) ultrasound probe will be placed in a longitudinal orientation above the level of the umbilicus with the Patient in the supine position. After identifying the rectus abdominis muscle, A 22 G echogenic needle using the in plane technique will be inserted just below the costal margin then, a total of 20 ml of 0.25% bupivacaine will be injected into the plane between the rectus muscle and posterior rectus sheath. Negative aspiration will be confirmed every 5 ml. The block will then be repeated on the other side.

Device: Ultrasound guided Rectus sheath block vs Erector spinae plane block

Erector spinae plane block group (ESPB)

ACTIVE COMPARATOR

After induction of anesthesia; the patient will be positioned on the lateral position. The skin will be prepared with povidone iodine, and a high frequency (5-10 MHz) ultrasound probewill be placed in a transverse orientation on the T9 spinous process which will be located by palpating and counting down from the C7 spinous process. The tip of the T9 transverse process will be identified and centred on the ultrasound screen, the probe will then be rotated into a longitudinal orientation to produce a parasagittal view. Correct location of the needle tip in the fascial plane deep to erector spinae muscle is confirmed by injecting 0.5-1 ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total of 20 ml of 0.25% bupivacaine will then be injected into the ESP of both sides.

Device: Ultrasound guided Rectus sheath block vs Erector spinae plane block

Interventions

Ultrasound guided Rectus sheath block vs Erector spinae plane block DEVICE

Ultrasound guided Rectus sheath block vs Erector spinae plane block

Erector spinae plane block group (ESPB); Rectus sheath block group (RSB)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I-II. Age: 18 to 60 years. Undergoing midline vertical laparotomy incisions (open colorectal resections or major ventral hernia repair).

You may not qualify if:

• Refusal of patients.
• Patients with coagulation disorders (Platelets ≤ 50,000 and/or INR\> 1.5).
• History of allergic reactions to local anesthetics.
• Rash or signs of infection at the injection site.
• Emergency surgery.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasralainy

Cairo, 11559, Egypt

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Khaled Sarhan, MD

  Lecturer of anesthesia, Cairo university

  PRINCIPAL INVESTIGATOR

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: principal investigator

Model Details: Study will be conducted on 60 adults aged from 18 to 60 years presented for major abdominal surgeries (open colorectal resections or major ventral hernia repair) at general surgery operating theatres, Cairo university hospitals. Patients will be divided into two equal groups; rectus sheath block group RSB (n=30) and erector spinae plane block group ESPB (n=30).

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: January 18, 2020
• Study Start: January 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

EG (1)