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

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

Conditions

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

Interventions

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 . 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.

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 . 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.

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 . 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.

Sponsors & Collaborators

• Mohamed, Ahmed A., M.D.

  collaborator INDIV

• Tarek Ahmed Radwan

  collaborator UNKNOWN

• Mohamed Mahmoud Mohamed

  collaborator UNKNOWN

• ismaiel saied hammad

  collaborator UNKNOWN

• Cairo University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-03-04

Primary Completion

2018-05-02

Completion

2018-05-06

Countries

• Egypt

Study Locations