Dexmedetomidine Versus Fentanyl As Adjuvants to Erector Spinae Plane Block for Postoperative Analgesia Following Simple Nephrectomy: a Randomized Clinical Trial

NCT06799442 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: DEX/Fentanyl ESPB Nephrectomy
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to compare the time to first analgesic request between dexmedetomidine and fentanyl as adjuvants in erector spinae plane block in patients undergoing simple nephrectomy . • Secondary outcome Pain scores; Numerical Rating Scale (NRS) at rest and when coughing \[at 1, 2, 4, 8, 16 and 24 hours postoperatively.\] The total opiod dose in the first 24 hours postoperatively. Duration of analgesia is defined as duration between block administration and time of first analgesic request. Any adverse effects related to anesthesia or the technique. Incidence of Postoperative nausea \& vomiting . Block related complication during and after block procedure till 24hours postoperatively (local anesthetic systemic toxicity, pneumothorax and vascular puncture during block procedure). Intraoperative haemodynamics parameters MAP ,HR , co2 and SP O2 . Postoperative haemodynamics parameters MAP , HR and SP O2 \[at 1, 2, 4, 8, 16 and 24 hours postoperatively. \]

Conditions

Nephrectomy

Keywords

Postoperative pain relief

Outcome Measures

Primary Outcomes (1)

• the time to first analgesic request

  To compare the time to first analgesic request between dexmedetomidine and fentanyl as adjuvants in erector spinae plane block in patients undergoing simple nephrectomy .

  24 hours

Secondary Outcomes (4)

• Pain scores

  24 hours

• The total opiod dose

  24 hours

• Duration of analgesia

  24 hours

• Postoperative nausea & vomiting

  24 hours

Study Arms (2)

Group dexmedetomidine

ACTIVE COMPARATOR

Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. Group D patients: A total of 30 ml Bupivacaine 0. 25%+ 50 mic dexmedetomidine which is diluted to 2ml.

Procedure: Erector Spinae Plane Block; Drug: Dexmedetomidine

Group fentanyl

ACTIVE COMPARATOR

Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. Group F patients : A total of 30 ml Bupivacaine 0.25% + 100 mic fentanyl which is also diluted to 2 ml.

Procedure: Erector Spinae Plane Block; Drug: fentanyl

Interventions

Erector Spinae Plane Block PROCEDURE

Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging.

Group dexmedetomidine; Group fentanyl

Dexmedetomidine DRUG

50 mic dexmedetomidine which is diluted to 2ml.

Group dexmedetomidine

fentanyl DRUG

100 mic fentanylwhich is also diluted to 2 ml.

Group fentanyl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years old Both sex patients who are American society of Anesthesiologists class I or

You may not qualify if:

• Patient's refusal.
• body mass index (BMI) ≥40 kg/m2.
• Local infection at site of block.
• Spine deformities
• History of hypersensitivity to the drugs being evaluated
• Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders.
• Chronic use of opioids and opioid addiction

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, Egypt

Location

Related Publications (12)

• Waloejo CS, Musalim DAP, Budi DS, Pratama NR, Sulistiawan SS, Wungu CDK. Dexmedetomidine as an Adjuvant to Nerve Block for Cancer Surgery: A Systematic Review and Meta-Analysis. J Clin Med. 2024 May 28;13(11):3166. doi: 10.3390/jcm13113166.

  PMID: 38892876 BACKGROUND

• Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789.

  PMID: 29746445 BACKGROUND

• Adhikary SD, Bernard S, Lopez H, Chin KJ. Erector Spinae Plane Block Versus Retrolaminar Block: A Magnetic Resonance Imaging and Anatomical Study. Reg Anesth Pain Med. 2018 Oct;43(7):756-762. doi: 10.1097/AAP.0000000000000798.

  PMID: 29794943 BACKGROUND

• De la Cuadra-Fontaine JC, Concha M, Vuletin F, Arancibia H. Continuous Erector Spinae Plane block for thoracic surgery in a pediatric patient. Paediatr Anaesth. 2018 Jan;28(1):74-75. doi: 10.1111/pan.13277. No abstract available.

  PMID: 29226529 BACKGROUND

• Finneran JJ 4th, Gabriel RA, Khatibi B. Erector Spinae Plane Blocks Provide Analgesia for Breast and Axillary Surgery: A Series of 3 Cases. Reg Anesth Pain Med. 2018 Jan;43(1):101-102. doi: 10.1097/AAP.0000000000000695. No abstract available.

  PMID: 29261601 BACKGROUND

• Bonvicini D, Giacomazzi A, Pizzirani E. Use of the ultrasound-guided erector spinae plane block in breast surgery. Minerva Anestesiol. 2017 Oct;83(10):1111-1112. doi: 10.23736/S0375-9393.17.12015-8. Epub 2017 May 11. No abstract available.

  PMID: 28492298 BACKGROUND

• Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.

  PMID: 28272292 BACKGROUND

• Capdevila X, Moulard S, Plasse C, Peshaud JL, Molinari N, Dadure C, Bringuier S. Effectiveness of Epidural Analgesia, Continuous Surgical Site Analgesia, and Patient-Controlled Analgesic Morphine for Postoperative Pain Management and Hyperalgesia, Rehabilitation, and Health-Related Quality of Life After Open Nephrectomy: A Prospective, Randomized, Controlled Study. Anesth Analg. 2017 Jan;124(1):336-345. doi: 10.1213/ANE.0000000000001688.

  PMID: 27918333 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

• Misiolek H, Cettler M, Woron J, Wordliczek J, Dobrogowski J, Mayzner-Zawadzka E. The 2014 guidelines for post-operative pain management. Anaesthesiol Intensive Ther. 2014 Sep-Oct;46(4):221-44. doi: 10.5603/AIT.2014.0041. No abstract available.

  PMID: 25293474 BACKGROUND

• Sharma V, Margreiter M. Partial nephrectomy: is there still a need for open surgery? Curr Urol Rep. 2013 Feb;14(1):1-4. doi: 10.1007/s11934-012-0297-2.

  PMID: 23233109 BACKGROUND

• Sahin A, Baran O. Effect of ultrasound-guided erector spinae plane block on post-surgical pain in patients undergoing nephrectomy: a single-center, randomized, double-blind, controlled trial. J Int Med Res. 2022 Mar;50(3):3000605221086737. doi: 10.1177/03000605221086737.

  PMID: 35301896 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• Moamen Mostafa Makkey, Doctor

  Assiut University

  STUDY CHAIR

Central Study Contacts

Alaa Mohamed Atia, Professor

CONTACT

01099923117; alaaguhina@aun.edu.eg

Abdelrahman Hamdy Mohamed, Doctor

CONTACT

+20 1060989574; Abdelrahmanhm89@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent anesthesiologist randomly divided the patients into 2 groups of 23 patients each using computer-generated random numbers dexmedetomidine group and fentanyl group (Group D and Group F). We discreetly placed the randomization results in envelopes until the end of the study. Both dexmedetomidine and fentanyl are colourless liquids, and they were digitally encoded after being diluted to 2 ml so that the researchers who are responsible for postoperative follow-up and data processing are blinded to the group allocation during the whole study period. All patients are also blinded to the group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physican

Model Details: Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. Group D patients: A total of 30 ml Bupivacaine 0. 25%+ 50 mic dexmedetomidine which is diluted to 2ml. Group F patients : A total of 30 ml Bupivacaine 0.25% + 100 mic fentanyl which is also diluted to 2 ml.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2024-09

Locations

EG (1)