Erector Spinae Plane Block for Post-nephrectomy Pain

NCT ID: NCT04537598

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-03
• Study Completion Date: 2022-06-15

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.

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patient controlled analgesia

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

Group Type: ACTIVE_COMPARATOR

Morphine patient controlled analgesia

Intervention Type: PROCEDURE

30 patients will receive PCA only for postoperative analgesia

Erector Spinae plane block

30 patients will receive continuous ESPB for postoperative analgesia.

Group Type: ACTIVE_COMPARATOR

Erector Spinae plane block

Intervention Type: PROCEDURE

30 patients will receive continuous ESPB for postoperative analgesia

Interventions

Morphine patient controlled analgesia

30 patients will receive PCA only for postoperative analgesia

Intervention Type: PROCEDURE

Erector Spinae plane block

30 patients will receive continuous ESPB for postoperative analgesia

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Ehab Hanafy Shaker

Assistant professor of Anesthesia, intensive care and pain releif

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ehab H Gendy, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Anesthesia, intensive care and pain releif

Locations

National Cancer Institute

Cairo, , Egypt

Countries

Egypt

Other Identifiers

ESPB for nephrectomy

Identifier Type: -

Identifier Source: org_study_id