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Dexmedetomidine in Splanchnic Nerve Neurolysis

Primary Purpose

Dexmedetomidine

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Group 1
Group 2
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dexmedetomidine focused on measuring Splanchnic Nerve Neurolysis, Chronic cancer Pain

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Minya University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

injection of ethanol and lidocaine with dexmedetomidine

injection of ethanol and lidocaine Without dexmedetomidine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the time of analgesic requirement
measure the time with hours passes after the injection to require additional analgesics as tramadol

Full Information

First Posted
March 3, 2022
Last Updated
July 29, 2023
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT05291364
Brief Title
Dexmedetomidine in Splanchnic Nerve Neurolysis
Official Title
The Effectiveness of Adding Dexmedetomidine to Alcohol in Splanchnic Nerve Neurolysis for the Treatment of Intra-Abdominal Cancer Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients fasted for 6 hours prior to the procedure, and a 20 G intravenous cannula was placed. Before the procedure, 500 mL of physiological saline was administered intravenously. The patient was positioned in the prone position on the surgical table with the chest supported using a pillow, to reverse the thoracolumbar lordosis and to increase the distance between the superior iliac spine and the chest cage. The patient was monitored using electrocardiography, non-invasive blood pressure measurements, and pulse oximetry in accordance with the standards proposed by the American Association of Anesthesiologists. On arrival at the operating room, electrocardiogram, pulse oximetry, and non-invasive arterial blood pressure were applied and vital signs were obtained. Twenty-two Gauge spinal needle introduced at 11th intercostal space 6 cm from midline and advanced to touch the anterolateral aspect of T11. Again, with AP and lateral views the placement of the needles was confirmed using contrast dye under fluoroscopy. Splanchnic nerve blockade will be performed by using (4.5 ml ethanol 96% + 1.5 ml of lidocaine 10 mg/ml) administered bilaterally (a total volume of 12 ml) with addition of 2 μg/kg dexmedetomidine patients in group (1). The procedure lasted 30 minutes, and the recovery period lasted 10 minutes since conscious sedation was used. After the procedure, patients were kept under medical observation for 4 to 6 hours to monitor possible hemodynamic complications. Parameters assessed: Hemodynamic parameters: Heart rate, respiratory rate and oxygen saturation were recorded before and immediately after the blockade and follow up on time intervals over 2 weeks after the blockade. Analgesic requirements: First time to require additional analgesics Visual Analogue Scale: The Visual Analogue Scale score (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'.The score of pain intensity was 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 Incidence of complications: In the form of hemodynamic instability, constitutional symptoms as (nausea, vomiting and diarrhea)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine
Keywords
Splanchnic Nerve Neurolysis, Chronic cancer Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
injection of ethanol and lidocaine with dexmedetomidine
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
injection of ethanol and lidocaine Without dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Group 1
Other Intervention Name(s)
dexmedetomidine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Group 2
Other Intervention Name(s)
ethanol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
the time of analgesic requirement
Description
measure the time with hours passes after the injection to require additional analgesics as tramadol
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haidy S Mansour
Organizational Affiliation
Associate professor
Official's Role
Study Director
Facility Information:
Facility Name
Minya University
City
Minya
ZIP/Postal Code
61519
Country
Egypt

12. IPD Sharing Statement

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Dexmedetomidine in Splanchnic Nerve Neurolysis

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