Transversus Abdominis Plane Block Versus Erector Spinae Plane Block

NCT03989570 | Completed Results

• 1 other identifier: 73-7/2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The TAP block, first described by Rafi in 2001, is comprised of deposition of a local anesthetic into the anatomical plane between the internal oblique and transverses abdominis muscles, where thess thoracoabdominal nerves (T6-L1) contribute to the main sensory supply of the skin, muscles, and parietal peritoneum of the anterior abdominal wall. These nerves branch and communicate extensively with each other in the TAP . Erector spinae plane (ESP) block is a recently described interfascial block in which the local anaesthectic is placed over or below the plane of the erector spinae muscle, near where the spinal nerves come out from the spine before they start to divide. Some publications have shown its effectiveness in treating thoracic and abdominal postoperative pain. Postoperative pain is the major obstacle for early postoperative ambulation and increases the risk of venous thromboembolism, respiratory complications and prolongs the hospital stay. Parietal pain is the chief component of postoperative pain after abdominal surgeries. Large doses of opioids are required to mitigate this pain, but they are poorly tolerated. Multimodal analgesia is effective in handling postoperative pain and in attenuating the side effects of large doses of a single analgesic .

Conditions

Postoperative Pain; Laparotomy

Keywords

Erector Spinae Plane Block; Transversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (2)

• Time of First Post Operative Analgesic Request

  the pain will be assisted based on the time for the first dose of rescue analgesia

  24 hours

• Postoperative Total Fentanyl Requirement

  The total amount of postoperative fentanyl in milligram was given to the patient as rescue analgesia during 24 hours

  24 hours

Secondary Outcomes (1)

• Incidence of Any Adverse Events

  5 days

Study Arms (3)

Group I (A group)

EXPERIMENTAL

31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).

Procedure: erector spinae plane block

Group II (B group)

ACTIVE COMPARATOR

31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).

Procedure: transversus abdominis plane block

Group III (C group)

PLACEBO COMPARATOR

31 patients anesthetized with the protocol followed by Minia University Hospital

Other: control group

Interventions

transversus abdominis plane block PROCEDURE

The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected

Group II (B group)

erector spinae plane block PROCEDURE

The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes

Group I (A group)

control group OTHER

placebo

Group III (C group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age18-70 . 2. Both gender . 3 .Emergency laparotomies . 4. ASA I-III .

You may not qualify if:

• Drug allergy .
• Morbid obesity (BMI \>40 kg/m2) .
• Psychiatric disorder .
• Opioid dependence .
• patient refuse

Sponsors & Collaborators

• Hassan Mokhtar Elshorbagy Hetta: lead

Study Sites (1)

Minia University Hospital

Minya, 61511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Dr. Hassan Elshorbagy
• Organization: Minia university

Hassan.Hetta@mu.edu.eg

1204427271

Study Officials

• Nagy S. Ali, MD

  Minia University Hospital

  STUDY CHAIR

• Abeer A Hassanien

  Minia University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecture

Study Record Dates

• First Submitted: May 4, 2019
• First Posted: June 18, 2019
• Study Start: May 15, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 12, 2020
• Last Updated: June 30, 2020
• Results First Posted: March 25, 2020

Record last verified: 2020-06

Locations

EG (1)