Evaluation of the Analgesic Effect of Dexmedetomidine Versus Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar 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

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine VS Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Bupivacaine; Drug: Fentanyl

Detailed Description

Relieving post-operative pain of spine surgeries has become an indispensable component in anesthesiology. Various methods have been tried for the management of post-operative pain in spine surgeries out of which regional techniques are becoming most promising. The quality of regional anesthesia has been reported to improve with the addition of opioids (such as morphine, fentanyl, and sufentanil) and other drugs (such as dexmedetomidine, clonidine, magnesium sulfate, neostigmine, ketamine, and midazolam), but no drug to inhibit nociception is without associated adverse effects . α2 adrenergic agonists have both analgesic and sedative properties when used as an adjuvant in regional anesthesia. Dexmedetomidine is an S-enantiomer of medetomidine with a higher specificity for α2-adrenoreceptor (α2 : α1, 1620 : 1) compared to clonidine (α2 : α1, 220 : 1). It was first introduced into practical use as intravenous sedative after the approval of U.S. Food and Drug Administration in 1999. Since then it has been investigated as the anxiolytic, sympatholytic, and analgesic properties related to α2-adrenoceptor binding, and it is now being used as a co-analgesic drug. As adjuvant, neuroaxial administration is the appropriate route to dexmedetomidine, because the analgesic effect of α2-agonists mostly occurs at spinal level, and dexmedetomidin's high lipophilicity facilitates rapid absorption into the cerebrospinal fluid and binding to the spinal cord α2-adrenoreceptor. regional-administeration of dexmedetomidine has been shown to exert potent antinociceptive effects in animals. To date, a few studies have reported on the effects of epidural dexmedetomidine combined with local anesthetics in humans. . Administration of an α2-agonist via an intrathecal or epidural route provides an analgesic effect in postoperative pain without severe sedation. This effect is due to the sparing of supraspinal CNS sites from excessive drug exposure, resulting in robust analgesia without heavy sedation . The adverse effects of dexmedetomidine include hypotension, hypertension, nausea, bradycardia, atrial fibrillation, and hypoxia. Fentanyl is one of the short-acting narcotic analgesics with potent morphine-like action . Neuroaxial administration of lipophilic opioids such as Fentanyl and sufentanyl tends to provide a rapid onset of analgesia. Their rapid clearance from cerebrospinal fluid may limit cephalic spread and the development of certain side effects such as delayed respiratory depression

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Ahmed Abdalla Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. All Patients below the age of 18 years and above 65 years. Also All female patient are excluded from the study.
2. Other spine surgeries rather than laminectomy, also surgeries on more than two levels.
3. Patients with haematological disease, bleeding or coagulation test abnormalities, psychiatric diseases.

4 .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.

5. Pregnant and lactating patients .

Withdrawal criteria :

Accidental Dural puncture.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Bupivacaine dexmedetomidine group; 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: Dexmedetomidine; 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 .; The pain score, by using VAS; Onset of analgesia (fall of VAS<4 ).; Peak level of analgesia ( VAS score 0).; Duration of analgesia (once the patient asks fwith VAS>4).; Monitoring of NIBP, pulse rate, respiratory rate every 30 min.; Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale>1" Also deep sedation "Ramsay sedation scale>3" , And shivering and hypotension.; Other Names: Dexmedetomidine bupivacaine versus fentanyl bupivacaine; Drug: Bupivacaine; 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 .; The pain score, by using VAS; Onset of analgesia (fall of VAS<4 ).; Peak level of analgesia ( VAS score 0).; Duration of analgesia (once the patient asks fwith VAS>4).; Monitoring of NIBP, pulse rate, respiratory rate every 30 min.; Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale>1" Also deep sedation "Ramsay sedation scale>3" , And shivering and hypotension.
ACTIVE_COMPARATOR: Bupivacaine fentanyl group; 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: Bupivacaine; 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 .; The pain score, by using VAS; Onset of analgesia (fall of VAS<4 ).; Peak level of analgesia ( VAS score 0).; Duration of analgesia (once the patient asks fwith VAS>4).; Monitoring of NIBP, pulse rate, respiratory rate every 30 min.; Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale>1" Also deep sedation "Ramsay sedation scale>3" , And shivering and hypotension.; Drug: Fentanyl; 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 .; The pain score, by using VAS; Onset of analgesia (fall of VAS<4 ).; Peak level of analgesia ( VAS score 0).; Duration of analgesia (once the patient asks fwith VAS>4).; Monitoring of NIBP, pulse rate, respiratory rate every 30 min.; Side-effects such as nausea, vomiting, respiratory depression, Motor blockade "Bromage scale>1" Also deep sedation "Ramsay sedation scale>3" , And shivering and hypotension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative assessment of pain	Post-operative assessment of pain using The Visual Analogue Scale (VAS: 0= no pain and 10 = worst possible pain).	24 hours
Complete sensory and motor block	Time taken to achieve complete sensory and motor block	24 hours
Sedation assessment	Post operative assessment of sedation using modified Ramsay scale (Grade 1, Patient is anxious and agitated or restless, 2, Patient is co-operative, oriented, and tranquil, 3, Patient responds to commands only; 4, Patient exhibits brisk response to light glabellar tap or loud auditory stimulus,5, Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus,6, Patient exhibits no response )	24 hours
Heart rate monitoring	Perioperative hemodynamics	24 hours
Mean arterial blood pressure	Perioperative hemodynamics	24 hours
Vomiting assessment	Post-operative assessment of vomiting	24 hours
Itching assessment	Post-operative assessment of itching	24 hours
Urine retention assessment	Post-operative assessment of urine retention	24 hours
Post-operative Neusea	Post-operative Neusea assessment	24 hours

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Mohamed, Ahmed A., M.D.; Tarek Ahmed Radwan; Mohamed Mahmoud Mohamed; ismaiel saied hammad

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2018
• Primary Completion (ACTUAL): May 2, 2018
• Study Completion (ACTUAL): May 6, 2018

Study Registration Dates

• First Submitted: December 29, 2017
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (ACTUAL): March 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 26, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: N-115-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Via scholar Gate

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No