Erector Spinae Plane Block for Post-nephrectomy Pain

NCT04537598 | Completed

• 1 other identifier: ESPB for nephrectomy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Acute postoperative pain proper management is important not only for patient satisfaction but also for patient outcome. It may also predispose patients to chronic post-surgical pain .Open nephrectomy is still conducted, although the use of laparoscopic or robotic surgery has increased recently. A flank approach with an eleventh rib partial resection.Several modalities have been implemented for acute postoperative pain control. Intravenous (IV) opioids is one of the earliest and most widely used method, it is insufficient only for managing postoperative pain in some patients with severe pain besides their side effects.ESPB is a relatively simple technique with easily identified sonographic landmarks. Additionally, the ESPB has the potential to provide both somatic and visceral sensory blockade.The aim of this study is to evaluate the effect of ESPB in acute postoperative pain and opioid consumption in patients undergoing open nephrectomy in renal cancer patients.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• measurement of visual analogue score

  it is a scoring system from 0 to 100 mm where 100 represents the worst pain and 0 indicates no pain

  1 week

Study Arms (2)

patient controlled analgesia

ACTIVE COMPARATOR

30 patients will receive only postoperative IV PCA alone for postoperative analgesia.

Procedure: Morphine patient controlled analgesia

Erector Spinae plane block

ACTIVE COMPARATOR

30 patients will receive continuous ESPB for postoperative analgesia.

Procedure: Erector Spinae plane block

Interventions

Morphine patient controlled analgesia PROCEDURE

30 patients will receive PCA only for postoperative analgesia

patient controlled analgesia

Erector Spinae plane block PROCEDURE

30 patients will receive continuous ESPB for postoperative analgesia

Erector Spinae 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.
• Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2.

You may not qualify if:

• Patient refusal
• Known sensitivity or contraindication to local anesthetics.
• History of psychological disorders.
• Localized infection at the site of block.
• Coagulopathies with platelet count below 50,000 or an INR\>1.5.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, Egypt

Location

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

• Ehab H Gendy, MD

  Assistant Professor of Anesthesia, intensive care and pain releif

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia, intensive care and pain releif

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 3, 2020
• Study Start: March 3, 2020
• Primary Completion: May 28, 2022
• Study Completion: June 15, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)