Erector Spinae vs TAP in Lower Abdominal Surgery

NCT04555993 | Unknown

• 1 other identifier: MS-39-2019
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the analgesic effect and safety profile of erector spinae plane block with transverses abdominis plane block in controlling peri-operative pain for lower abdominal cancer surgery.

Conditions

Postoperative Pain

Keywords

erector spinae block; TAP Block; abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  The total amount of morphine which was consumed post-operatively measured in milligrams

  24 hours

Secondary Outcomes (1)

• Intraoperative fentanyl consumption.

  intraoperative

Other Outcomes (5)

• Postoperative nausea and vomiting

  24 hours postoperative

• Time for first rescue analgesia.

  24 hours postoperative

• Heart rate

  24 hours

Study Arms (2)

Transversus abdomis plane block

ACTIVE COMPARATOR

Patients will receive Transversus abdomis plane block

Procedure: lower abdominal surgery; Other: Transversus abdominis plane block

Erector spinae plane block

EXPERIMENTAL

Patients will receive Erector spinae plane block.

Procedure: lower abdominal surgery; Other: Erector spinae plane block

Interventions

lower abdominal surgery PROCEDURE

Patients will undergo lower abdominal surgery under general anesthesia.

Erector spinae plane block; Transversus abdomis plane block

Erector spinae plane block OTHER

patients will receive erector spinae plane block using 20 mL levobupivacaine (0.25%).

Erector spinae plane block

Transversus abdominis plane block OTHER

patients will receive transversus abdominis plane block using 20 mL levobupivacaine (0.25%).

Transversus abdomis plane block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physical status ASA II.
• Age ≥ 18 and ≤ 65 Years.
• Cancer patients undergoing laparotomies for radical cystectomy or radical hysterectomy or low anterior resection (lower abdominal procedures).
• Patient is able to provide a written informed consent.
• Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2.

You may not qualify if:

• Age \<18 years or \>65 years.
• BMI \<20 kg/m2 and \>40 kg/m2.
• Known sensitivity to local anaesthetics and morphine.
• History of psychological disorders and/or chronic pain.
• Significant liver or renal insufficiency.
• Contraindication to regional anaesthesia e.g. local sepsis, preexisting peripheral neuropathies and coagulopathy.
• Patient refusal.
• Severe respiratory or cardiac disorders.
• Pregnancy.
• ASA III-IV.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, Egypt

RECRUITING

Related Publications (9)

• Randerath WJ, George S. Opioid-induced sleep apnea: is it a real problem? J Clin Sleep Med. 2012 Oct 15;8(5):577-8. doi: 10.5664/jcsm.2162. No abstract available.

  PMID: 23066371 BACKGROUND

• Finnerty O, Carney J, McDonnell JG. Trunk blocks for abdominal surgery. Anaesthesia. 2010 Apr;65 Suppl 1:76-83. doi: 10.1111/j.1365-2044.2009.06203.x.

  PMID: 20377549 BACKGROUND

• Hebbard P. Subcostal transversus abdominis plane block under ultrasound guidance. Anesth Analg. 2008 Feb;106(2):674-5; author reply 675. doi: 10.1213/ane.0b013e318161a88f. No abstract available.

  PMID: 18227342 BACKGROUND

• Yarwood J, Berrill A (2010). Nerve blocks of the anterior abdominal wall, Continuing Education in Anaesthesia Critical Care & Pain, Vol10, Issue 6, pp 182-186.

  BACKGROUND

• Abrahams MS, Horn JL, Noles LM, Aziz MF. Evidence-based medicine: ultrasound guidance for truncal blocks. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S36-42. doi: 10.1097/AAP.0b013e3181d32841.

  PMID: 20216023 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.

  PMID: 28188621 BACKGROUND

• Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.

  PMID: 28252539 BACKGROUND

• De Cassai A, Marchet A, Ori C. The combination of erector spinae plane block and pectoralis blocks could avoid general anesthesia for radical mastectomy in high risk patients. Minerva Anestesiol. 2018 Dec;84(12):1420-1421. doi: 10.23736/S0375-9393.18.13031-8. Epub 2018 Jul 9. No abstract available.

  PMID: 29991225 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• waleed hamimy, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

ahmed hasanin, Professor

CONTACT

+201095076954; ahmedmohamedhasanin@gmail.com

ahmed zaghloul, Professor

CONTACT

00201001839591; a_zaghloul2000@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of anesthesia and critical care medicine

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 21, 2020
• Study Start: February 28, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 15, 2020
• Last Updated: September 21, 2020

Record last verified: 2020-09

Locations

EG (1)