Dexmedetomidine in Splanchnic Nerve Neurolysis

NCT05291364 | Completed

• 1 other identifier: 673-8/2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Malignancy related abdominal and pelvic pain can be debilitating and affects survival as well as quality of life. Pain from cancer and its treatments can result in anxiety, depression, fear, anger, helplessness, and hopelessness, and those with both pain and depression have an amplification of disability and poor quality of life Pancreatic and other upper abdominal organ malignancies can produce intense visceral pain syndromes that are frequently treated with splanchnic nerve neurolysis (SNN) or celiac plexus neurolysis (CPN). Dexmedetomidine is a selective alpha two adreno-receptor agonist. It provides dose-dependent sedation, analgesia, sympatholysis, and anxiolysis without relevant respiratory depression. Dexmedetomidine is used as adjuvant to LA drugs in peripheral nerve block, brachial plexus block and intrathecal anesthesia with satisfactory results. The aim of this study is to evaluate effect of addition of dexmedetomidine as an adjuvant to alcohol and local anesthetics for chemical neurolysis to control pain in patients with intra-abdominal malignancy.

Conditions

Dexmedetomidine

Keywords

Splanchnic Nerve Neurolysis; Chronic cancer Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  Visual Analogue Scale which measure the pain intensity . It determined by patients providing a mark between 0-10 cm with score from 0-4 cm mild pain. 5- 7 cm moderated and 8-10 severe pain. it was recorded prior to injection and after injection by 6,12,24,72 hours and after one and two weeks

  2 weeks

Secondary Outcomes (1)

• the time of analgesic requirement

  2 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

injection of ethanol and lidocaine with dexmedetomidine

Drug: Group 1

Group 2

ACTIVE COMPARATOR

injection of ethanol and lidocaine Without dexmedetomidine

Drug: Group 2

Interventions

Group 1 DRUG

Is formed of 20 patients had splanchnic plexus block with 4.5 ml ethanol 96% + 1.5 ml of lidocaine 10 mg/ml + 2 μg/kg dexmedetomidine diluted in 0.9% sterile saline (total volume 12 ml) on each side

Also known as: dexmedetomidine

Group 1

Group 2 DRUG

Is formed of 20 patients had splanchnic plexus block with 4.5 ml ethanol 96% + 1.5 ml of lidocaine 10 mg/ml diluted in 0.9% sterile saline (total volume 12 ml) on each side.

Also known as: ethanol

Group 2

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed to have abdominal malignancy aged 25 to 70 years old
• Fully conscious
• Patient has no hematological disease or coagulation abnormality.
• Patient has no history of mental illness
• Patient with persistent and moderate to severe abdominal pain visual analogue scale score \> 4.

You may not qualify if:

• Patient refusal of the procedure
• Extremes of age
• Patients with psychiatric disorders
• Patient diagnosed to have any coagulation defect or bleeding tendency
• Patients with cardiopulmonary significant condition
• Skin infection or wounds at site of proposed needle insertion site

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minya University

Minya, 61519, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Ethanol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Alcohols; Organic Chemicals

Study Officials

• Haidy S Mansour

  Associate professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 22, 2022
• Study Start: September 30, 2020
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

EG (1)