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

NCT04719507 | Unknown

• 1 other identifier: pain control in nephrectomy
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pain, Postoperative

Keywords

open nephrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Visual analogue score at 2, 4, 6, 12, 18, and 24 hours postoperatively

  2, 4, 6, 12, 18, and 24 hours postoperatively

• Time span to the first postoperative analgesia

  calculated from the time of intervention till the time of the first rescue dose of morphine,expected form 2-3 hours

• operation time

  from start of anesthesia till the end of surgery , expected from 3-4 hours

Study Arms (3)

erector spinae arm

EXPERIMENTAL

ultrasound guided erector spinae block

Procedure: erector spinae block

thoracic paravertebral arm

EXPERIMENTAL

ultrasound guided thoracic paravertebral block.

Procedure: thoracic paravertebral block

drug arm

ACTIVE COMPARATOR

pethidine (1 mg/kg ) once

Drug: Pethidine Only Product in Parenteral Dose Form

Interventions

erector spinae block PROCEDURE

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.

Also known as: erector spinae plane block

erector spinae arm

thoracic paravertebral block PROCEDURE

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.

thoracic paravertebral arm

Pethidine Only Product in Parenteral Dose Form DRUG

pethidine (1 mg/kg ) once

drug arm

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (14)

• 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.

  PMID: 28663622 BACKGROUND

• 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. doi: 10.1093/bja/ael020. Epub 2006 Feb 13.

  PMID: 16476698 BACKGROUND

• Kehlet H, Rung GW, Callesen T. Postoperative opioid analgesia: time for a reconsideration? J Clin Anesth. 1996 Sep;8(6):441-5. doi: 10.1016/0952-8180(96)00131-6.

  PMID: 8872683 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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. No abstract available.

  PMID: 29065335 BACKGROUND

• 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. No abstract available.

  PMID: 29149734 BACKGROUND

• 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. No abstract available.

  PMID: 30690313 BACKGROUND

• 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. doi: 10.21873/anticanres.12024.

  PMID: 28982906 BACKGROUND

• 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.

  PMID: 31827657 BACKGROUND

• Greengrass R, Buckenmaier CC 3rd. Paravertebral anaesthesia/analgesia for ambulatory surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):271-83. doi: 10.1053/bean.2002.0238.

  PMID: 12491557 BACKGROUND

• 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.

  PMID: 24341324 BACKGROUND

• Gurkan Y, Aksu C, Kus A, Yorukoglu 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.

  PMID: 31280100 BACKGROUND

• 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.

  PMID: 30292068 BACKGROUND

• 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.

  PMID: 19004914 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Injections

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

ezzat ezz

CONTACT

01284994135; ezzatramzy627@gmail.com

Karim ghaleb

CONTACT

01007451161; karim.ghaleb87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: January 9, 2021
• First Posted: January 22, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: January 22, 2021

Record last verified: 2021-01