Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy
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| ClinicalTrials.gov Identifier: NCT04719507 |
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Recruitment Status :
Not yet recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain, Postoperative | Procedure: erector spinae block Procedure: thoracic paravertebral block Drug: Pethidine Only Product in Parenteral Dose Form | Not Applicable |
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 .
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 45 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Care Provider) |
| Primary Purpose: | Supportive Care |
| Official Title: | Ultrasound Guided Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy : A Randomized Controlled Trial |
| Estimated Study Start Date : | January 2021 |
| Estimated Primary Completion Date : | January 2022 |
| Estimated Study Completion Date : | March 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: erector spinae arm
ultrasound guided erector spinae block
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Procedure: erector 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.
Other Name: erector spinae plane block |
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Experimental: thoracic paravertebral arm
ultrasound guided thoracic paravertebral block.
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Procedure: thoracic 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. |
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Active Comparator: drug arm
pethidine (1 mg/kg ) once
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Drug: Pethidine Only Product in Parenteral Dose Form
pethidine (1 mg/kg ) once |
- Total morphine requirements 24 hours postoperatively [ Time Frame: 24 hours postoperative ]morphine 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
- Visual analogue score at 2, 4, 6, 12, 18, and 24 hours postoperatively [ Time Frame: 2, 4, 6, 12, 18, and 24 hours postoperatively ]the 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 analgesia [ Time Frame: calculated from the time of intervention till the time of the first rescue dose of morphine,expected form 2-3 hours ]Time span to the first postoperative analgesic request to be started from the time of the block till the first rescue dose of morphine
- operation time [ Time Frame: from start of anesthesia till the end of surgery , expected from 3-4 hours ]Duration of the anesthesia and surgery to be documented
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| Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04719507
| Contact: ezzat ezz | 01284994135 | ezzatramzy627@gmail.com | |
| Contact: Karim ghaleb | 01007451161 | karim.ghaleb87@gmail.com |
| Responsible Party: | Ezzat Ramzy Ezz, principle investigator, Cairo University |
| ClinicalTrials.gov Identifier: | NCT04719507 |
| Other Study ID Numbers: |
pain control in nephrectomy |
| First Posted: | January 22, 2021 Key Record Dates |
| Last Update Posted: | January 22, 2021 |
| Last Verified: | January 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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open nephrectomy |
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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Meperidine Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia |