Erector Spinae Plane Block for Post-nephrectomy Pain

Sponsor
National Cancer Institute, Egypt (Other)
Overall Status
Completed
CT.gov ID
NCT04537598
Collaborator
(none)
60
1
2
27.4
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Morphine patient controlled analgesia
  • Procedure: Erector Spinae plane block
N/A

Detailed Description

Acute postoperative pain proper management is important not only for patient satisfaction but also for patient outcome. In addition to its early effects, poorly controlled acute postoperative pain may 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, which is the main method for open nephrectomy at our institution, could make for better dissection of the renal pelvis and the pedicles, and provide the best circumstances for nephrectomy; however, it induces more persistent pain compared with other approaches.

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. In addition, opioids have many side effects like respiratory depression, nausea, vomiting and constipation hence it is important to decrease opioids use and the transition to other modalities such as regional blocks, nerve blocks, NSAIDs and multimodalities.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 erector spinae muscle (ESM) is a complex formed by the spinalis, longissimus thoracis, and iliocostalis muscles that run vertically in the back. The ESP block is performed by depositing the local anesthetic (LA) in the fascial plane, deeper than the ESM at the tip of the transverse process of the vertebra. Hence, LA is distributed in the cranio-caudal fascial plane.Additionally, it diffuses anteriorly to the paravertebral and epidural spaces, and laterally to the intercostal space at several levels.

There are different case studies about the use of erector spinae block in nephrectomy but there is no randomized controlled study about it until now so it will be one of the earliest studies that investigate the effect of ESPB to relief acute postoperative pain in patients undergoing open nephrectomy.

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ultrasound Guided Continuous Erector Spinae Plane Block Versus Patient Controlled Analgesia in Patients Undergoing Nephrectomy for Renal Malignancies: A Randomized Controlled Study
Actual Study Start Date :
Mar 3, 2020
Actual Primary Completion Date :
May 28, 2022
Actual Study Completion Date :
Jun 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: patient controlled analgesia

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

Procedure: Morphine patient controlled analgesia
30 patients will receive PCA only for postoperative analgesia

Active Comparator: Erector Spinae plane block

30 patients will receive continuous ESPB for postoperative analgesia.

Procedure: Erector Spinae plane block
30 patients will receive continuous ESPB for postoperative analgesia

Outcome Measures

Primary Outcome Measures

  1. measurement of visual analogue score [1 week]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Physical status ASA II.

  • Age ≥ 18 and ≤ 65 Years.

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

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cancer Institute Cairo Egypt

Sponsors and Collaborators

  • National Cancer Institute, Egypt

Investigators

  • Principal Investigator: Ehab H Gendy, MD, Assistant Professor of Anesthesia, intensive care and pain releif

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ehab Hanafy Shaker, Assistant professor of Anesthesia, intensive care and pain releif, National Cancer Institute, Egypt
ClinicalTrials.gov Identifier:
NCT04537598
Other Study ID Numbers:
  • ESPB for nephrectomy
First Posted:
Sep 3, 2020
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2022