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Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy

Ultrasound Guided Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy : A Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04719507
Enrollment
45
Registered
2021-01-22
Start date
2021-01-31
Completion date
2022-03-31
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

open nephrectomy

Brief summary

the study aims to compare the analgesic efficacy of erector spinae plane block versus thoracic paravertebral block after open nephrectomy surgery.

Detailed description

Open nephrectomy is associated with substantial postoperative pain, pain relief in patients undergoing this procedure is usually provided either by thoracic epidural analgesia (EA) or systemic analgesics. EA is a very useful option for the management of postoperative pain in patients undergoing abdominal surgeries, but the risks and contraindications linked to EA like hypotension ,headache ,nerve damage or infection may limit its use. Systemic analgesics in the form of opioid analgesics may give rise to side effects like nausea ,vomiting ,constipation, allergy or drowsiness and often provide insufficient analgesia. Hence, other methods of postoperative pain management are desired. Sensory level target according to the incision site Flank(T9-T11) , Thoraco-abdominal (T7-T12 ) and Trans-abdominal (T6-T10). Ultrasound (US) guided erector spinae plane (ESP) block is one of the interfascial plane blocks that target the dorsal and ventral rami of the spinal nerves. Although there is no sufficient evidence for the spread of local anesthetic to the ventral rami, recent anecdotal reports demonstrated effective postoperative analgesia after thoracic and lumbar surgeries affecting both the ventral and dorsal rami .According to a previous study, Erector Spinae Plane block has allowed a reduction in opioid consumption and excellent pain control in partial nephrectomy. Paravertebral block (PVB) is a technique where a local anesthetic is deposited into a space found on both sides of the spine, called the paravertebral space. It is a block with a dermatomal distribution of pain relief depending on the level of the spine at which the block is sited and the quantity and type of deposited local anesthetic. PVB is effective for pain relief in the thoracic, abdominal and limb regions .

Interventions

PROCEDUREerector spinae block

ultrasound probe is placed parallel to the vertebral spine at T4 level and shifted 3 cm laterally to obtain the appropriate visualization. Under aseptic precautions, the needle is inserted and advanced perpendicular to the skin in all planes to contact the transverse process of the vertebra at a variable depth of 2-4 cm from the skin depending on the build of the individual. At this point, the needle tip lies between the erector spinae muscle and transverse process. After negative aspiration, 20 ml of 0.25% bupivacaine is administered in cephalad and caudal directions.

PROCEDUREthoracic paravertebral block

ultrasound probe is placed parallel to the vertebral spine at T4 level and shifted 2-3 cm laterally to obtain the appropriate visualization. Following the identification of pleura, transverse process and paravertebral space, the needle is inserted cranial to caudal direction using in-plane approach . After confirming the displacement of pleura with 0.5-1 ml of local anesthetic (LA), 20 ml of 0.25% bupivacaine is administered for the block.

DRUGPethidine Only Product in Parenteral Dose Form

pethidine (1 mg/kg ) once

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Adult patients (30-60 years) . * Patients with ASA I , II score

Exclusion criteria

* Patient's refusal * Coagulopathy to be cancelled if ( INR\>1.4 , Platelets count \<100x109 ) * Infection at the injection site. * Allergy to local anesthetics. * Patients receiving opioids for chronic analgesic therapy

Design outcomes

Primary

MeasureTime frameDescription
Total morphine requirements 24 hours postoperatively24 hours postoperativemorphine increment ( 0.02 mg/kg IV ) will be added to maintain a resting visual analogue score at \<3 and the total 24-hours morphine consumption will be recorded

Secondary

MeasureTime frameDescription
Visual analogue score at 2, 4, 6, 12, 18, and 24 hours postoperatively2, 4, 6, 12, 18, and 24 hours postoperativelythe score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity .no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Time span to the first postoperative analgesiacalculated from the time of intervention till the time of the first rescue dose of morphine,expected form 2-3 hoursTime span to the first postoperative analgesic request to be started from the time of the block till the first rescue dose of morphine
operation timefrom start of anesthesia till the end of surgery , expected from 3-4 hoursDuration of the anesthesia and surgery to be documented

Contacts

Primary Contactezzat ezz
ezzatramzy627@gmail.com01284994135
Backup ContactKarim ghaleb
karim.ghaleb87@gmail.com01007451161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026