NCT03463083

Brief Summary

To determine if the epidural route provide an acceptable analgesia in spine surgeries and avoided the need for excessive IV analgesics. Also to determine whatever dexmedetomidine or fentanyl is more better neuroaxial adjuvant regarding providing early onset and prolonged analgesia and stable cardiorespiratory parameters

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 4, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

December 29, 2017

Last Update Submit

May 26, 2018

Conditions

Dexmedetomidine VS Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries

Outcome Measures

Primary Outcomes (1)

  • Post-operative analgesia duration assessment

    The duration of effective analgesia; "it is the duration of complete pain relief (zero pain) and ends by the appearance of any pain (even VAS is of one)."

    24 hours

Secondary Outcomes (9)

  • Post-operative assessment of pain

    24 hours

  • Complete sensory and motor block

    24 hours

  • Sedation assessment

    24 hours

  • Heart rate monitoring

    24 hours

  • Mean arterial blood pressure

    24 hours

  • +4 more secondary outcomes

Study Arms (2)

Bupivacaine dexmedetomidine group

ACTIVE COMPARATOR

Group 1 (bupivacaine + dexmedetomidine (BD) group); will Receive an epidural study solution of 18 ml of 0.25% of bupivacaine hydrochloride plus 1 ml of dexmedetomidine (1 mcg/kg) plus 1 ml normal saline keeping the total volume of 20 ml in a syringe pump .

Drug: DexmedetomidineDrug: Bupivacaine

Bupivacaine fentanyl group

ACTIVE COMPARATOR

Group 2 (bupivacaine + fentanyl (BF) group) ; will Receive an epidural study solution of 18 ml of 0.25% bupivacaine plus 2 ml fentanyl (1 mcg/kg) keeping the total volume of 20 ml in a syringe pump .

Drug: BupivacaineDrug: Fentanyl

Interventions

DexmedetomidineDRUG

All cases of spine surgery will be done under G.A with the patient in prone position. After surgery an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of\>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted . 1. The pain score, by using VAS 2. Onset of analgesia (fall of VAS\<4 ). 3. Peak level of analgesia ( VAS score 0). 4. Duration of analgesia (once the patient asks fwith VAS\>4). 5. Monitoring of NIBP, pulse rate, respiratory rate every 30 min. 6. Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale\>1" Also deep sedation "Ramsay sedation scale\>3" , And shivering and hypotension.

Also known as: Dexmedetomidine bupivacaine versus fentanyl bupivacaine
Bupivacaine dexmedetomidine group
BupivacaineDRUG

All cases of spine surgery will be done under G.A with the patient in prone position. After surgury an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of\>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted . 1. The pain score, by using VAS 2. Onset of analgesia (fall of VAS\<4 ). 3. Peak level of analgesia ( VAS score 0). 4. Duration of analgesia (once the patient asks fwith VAS\>4). 5. Monitoring of NIBP, pulse rate, respiratory rate every 30 min. 6. Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale\>1" Also deep sedation "Ramsay sedation scale\>3" , And shivering and hypotension.

Bupivacaine dexmedetomidine groupBupivacaine fentanyl group
FentanylDRUG

All cases of spine surgery will be done under G.A with the patient in prone position. After surgury an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of\>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted . 1. The pain score, by using VAS 2. Onset of analgesia (fall of VAS\<4 ). 3. Peak level of analgesia ( VAS score 0). 4. Duration of analgesia (once the patient asks fwith VAS\>4). 5. Monitoring of NIBP, pulse rate, respiratory rate every 30 min. 6. Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale\>1" Also deep sedation "Ramsay sedation scale\>3" , And shivering and hypotension.

Bupivacaine fentanyl group

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales only included in the study to abolish sex difference in pain perception which is attributed to social conditioning and to psychological factors. Also many laboratory studies of humans have described sex differences in sensitivity to noxious stimuli, suggesting that biological mechanisms underlie such difference. In addition, sex hormones influence pain sensitivity)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All male patients between the age group of 18 and 65 years
  • Patients of American Society of Anaesthesiologists (ASA) class I and II.
  • Patients who will undergo lumbar spine surgeries (laminectomy ± discectomy for PIVD (Prolapse of intervertebral disc), will be enrolled for this study

You may not qualify if:

  • All Patients below the age of 18 years and above 65 years. Also All female patient are excluded from the study.
  • Other spine surgeries rather than laminectomy, also surgeries on more than two levels.
  • Patients with haematological disease, bleeding or coagulation test abnormalities, psychiatric diseases.
  • Patiensts with history of drug abuse, allergy to any study medication. . 4 .Patients with cervical and thoracic spine surgeries, tubercular spine , any permanent neurological disorders and vertebral deformeties such as scoliosis and spondylolisthesis.
  • \. Pregnant and lactating patients .
  • Withdrawal criteria :
  • Accidental Dural puncture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

MeSH Terms

Interventions

DexmedetomidineBupivacaineFentanyl

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator assessing study outcomes will all be blinded to the study groups allocation. The study drugs will be prepared by a separate investigator not involved in outcome assessment
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This double-blind, prospective, randomised clinically controlled study is designed to study the efficacy of epidural analgesia of dexmedetomidine and compare the analgesic effect of its epidural injection with bupivacaine versus fentanyl with bupivacaine in the post operative period of elective spine surgeries. To determine if the epidural route provide an acceptable analgesia in spine surgeries and avoided the need for excessive IV analgesics. Also to determine whatever dexmedetomidine or fentanyl is more better neuroaxial adjuvant regarding providing early onset and prolonged analgesia and stable cardiorespiratory parameters.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia &I.C.U and Pain Clinic

Study Record Dates

First Submitted

December 29, 2017

First Posted

March 13, 2018

Study Start

March 4, 2018

Primary Completion

May 2, 2018

Study Completion

May 6, 2018

Last Updated

May 30, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Via scholar Gate

Locations

EG(1)