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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04719507
• Other study ID #: pain control in nephrectomy
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: March 2022

Study information

• Verified date: January 2021
• Source: Cairo University
• Contact: ezzat ezz
• Phone: 01284994135
• Email: ezzatramzy627[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: March 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.
• 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.

Drug:
• Pethidine Only Product in Parenteral Dose Form
pethidine (1 mg/kg ) once

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (14)

Baik JS, Oh AY, Cho CW, Shin HJ, Han SH, Ryu JH. Thoracic paravertebral block for nephrectomy: a randomized, controlled, observer-blinded study. Pain Med. 2014 May;15(5):850-6. doi: 10.1111/pme.12320. Epub 2013 Dec 16. — View Citation

Bonvicini D, Tagliapietra L, Giacomazzi A, Pizzirani E. Bilateral ultrasound-guided erector spinae plane blocks in breast cancer and reconstruction surgery. J Clin Anesth. 2018 Feb;44:3-4. doi: 10.1016/j.jclinane.2017.10.006. Epub 2017 Oct 21. — View Citation

Chu L, Zhang X, Lu Y, Xie G, Song S, Fang X, Cheng B. Improved Analgesic Effect of Paravertebral Blocks before and after Video-Assisted Thoracic Surgery: A Prospective, Double-Blinded, Randomized Controlled Trial. Pain Res Manag. 2019 Nov 18;2019:9158653. doi: 10.1155/2019/9158653. eCollection 2019. — View Citation

Davies RG, Myles PS, Graham JM. A comparison of the analgesic efficacy and side-effects of paravertebral vs epidural blockade for thoracotomy--a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2006 Apr;96(4):418-26. Epub 2006 Feb 13. Review. Erratum in: Br J Anaesth. 2007 Nov;99(5):768. — View Citation

Forastiere E, Sofra M, Giannarelli D, Fabrizi L, Simone G. Effectiveness of continuous wound infusion of 0.5% ropivacaine by On-Q pain relief system for postoperative pain management after open nephrectomy. Br J Anaesth. 2008 Dec;101(6):841-7. doi: 10.1093/bja/aen309. — View Citation

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. — View Citation

Gautam SKS, Das PK, Agarwal A, Kumar S, Dhiraaj S, Keshari A, Patro A. Comparative Evaluation of Continuous Thoracic Paravertebral Block and Thoracic Epidural Analgesia Techniques for Post-operative Pain Relief in Patients Undergoing Open Nephrectomy: A Prospective, Randomized, Single-blind Study. Anesth Essays Res. 2017 Apr-Jun;11(2):359-364. doi: 10.4103/0259-1162.194559. — View Citation

Greengrass R, Buckenmaier CC 3rd. Paravertebral anaesthesia/analgesia for ambulatory surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):271-83. Review. — View Citation

Gürkan Y, Aksu C, Kus A, Yörükoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4. — View Citation

Karmakar MK, Samy W, Lee A, Li JW, Chan WC, Chen PP, Tsui BCH. Survival Analysis of Patients with Breast Cancer Undergoing a Modified Radical Mastectomy With or Without a Thoracic Paravertebral Block: a 5-Year Follow-up of a Randomized Controlled Trial. Anticancer Res. 2017 Oct;37(10):5813-5820. — View Citation

Kehlet H, Rung GW, Callesen T. Postoperative opioid analgesia: time for a reconsideration? J Clin Anesth. 1996 Sep;8(6):441-5. Review. — View Citation

Santonastaso DP, de Chiara A, Musetti G, Bagaphou CT, Gamberini E, Agnoletti V. Ultrasound guided erector spinae plane block for open partial nephrectomy: only an alternative? J Clin Anesth. 2019 Sep;56:55-56. doi: 10.1016/j.jclinane.2019.01.036. Epub 2019 Jan 25. — View Citation

Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3. Review. — View Citation

Tulgar S, Senturk O. Ultrasound guided Erector Spinae Plane block at L-4 transverse process level provides effective postoperative analgesia for total hip arthroplasty. J Clin Anesth. 2018 Feb;44:68. doi: 10.1016/j.jclinane.2017.11.006. Epub 2017 Nov 14. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine requirements 24 hours postoperatively	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	24 hours postoperative
Secondary	Visual analogue score at 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)	2, 4, 6, 12, 18, and 24 hours postoperatively
Secondary	Time span to the first postoperative analgesia	Time span to the first postoperative analgesic request to be started from the time of the block till the first rescue dose of morphine	calculated from the time of intervention till the time of the first rescue dose of morphine,expected form 2-3 hours
Secondary	operation time	Duration of the anesthesia and surgery to be documented	from start of anesthesia till the end of surgery , expected from 3-4 hours