Comparative Study Between Two Adjuvant Drugs to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries
Primary Purpose
Epidural Analgesia
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Control Analgesic regimen
Fentanyl Analgesic regimen
Dexmedetomidine Analgesic regimen
Sponsored by
About this trial
This is an interventional supportive care trial for Epidural Analgesia
Eligibility Criteria
Inclusion Criteria:
- ASA I or ASA II patients.
- Age group: 21-70 years old.
- BMI ≤40
- Duration of procedure ≤ 180 minutes.
Exclusion Criteria:
- Patients with known neurologic and psychiatric illness will be excluded from the study.
- Contraindications for epidural anesthesia as patient refusal, bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia
- Spine abnormalities.
- Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency.
- Allergy to any of the drugs used in the study.
Sites / Locations
- Ain Shams University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Control group
Fentanyl group
Dexmedetomidine group
Arm Description
Normal saline 2 ml will be mixed with 48 ml bupivacaine 0.125% in an elastomeric pump. The rate of epidural infusion will be 5ml/hr for the postoperative 24 hours.
Fentanyl 2 ml (100 μg) will be mixed with 48 ml bupivacaine 0.125% in an elastomeric pump. The rate of epidural infusion will be 5ml/hr for the postoperative 24 hours.
Dexmedetomidine 1 ml (100 μg) plus 1 ml normal saline will be mixed with 48 ml bupivacaine 0.125% in an elastomeric pump. The rate of epidural infusion will be 5ml/hr for the postoperative 24 hours.
Outcomes
Primary Outcome Measures
Onset of sensory analgesia
will be assessed by pin prick and cold application from the start of epidural infusion till scoring 1 at the 3 point scale. Assessment will be done every 5 minutes until the onset of sensory block using a 3-point scale: 0=normal sensation, 1=loss of sensation of pin prick (analgesia), and 2=loss of sensation of touch (anesthesia).
Duration of analgesia
time from starting epidural infusion to the time of the first request for additional pain medication
Secondary Outcome Measures
Postoperative pain score
for 24 hours using the Visual Analogue Scale ranging from 0 to 10 (0 - no pain, 10 - worst pain ever) at 0, 2, 6, 12 and 24 hrs after starting epidural infusion.
Analgesic consumption
during the 24 hours following epidural infusion.
The motor block
will be assessed if occurred by Bromage three point score (0-3) for the lower extremity during the 24 hours following epidural infusion where 0: no motor impairment (able to move the hip, knee, and ankle joints);
unable to raise either extended leg (able to move joints of knee and ankle);
unable to raise extended leg and flex knee (able to move joint of ankle); 3; unable to move knee and foot.
Post operative Mean arterial Blood pressure
Mean arterial pressure in mmHg will be monitored continuously and recorded just before the initiation of epidural infusion and thereafter at 2, 6, 12 and 24 hrs. postoperatively during the 24 hours following epidural infusion
Post operative Heart rate
Heart rate (HR) in beats per minute (bpm) will be monitored continuously and recorded just before the initiation of epidural infusion and thereafter at 2, 6, 12 and 24 hrs. postoperatively during the 24 hours following epidural infusion
Post operative Peripheral oxygen saturation
Peripheral oxygen saturation in blood (SpO2) will be monitored continuously and recorded just before the initiation of epidural infusion and thereafter at 2, 6, 12 and 24 hrs. postoperatively during the 24 hours following epidural infusion
Anticipated adverse events
like postoperative nausea and vomiting during the 24 hours from the start of epidural analgesia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05323214
Brief Title
Comparative Study Between Two Adjuvant Drugs to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries
Official Title
Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Epidural analgesia is associated with early postoperative mobilization and rehabilitation with minimally associated pain and discomfort. Analgesic effect of local anesthetics is augmented by addition of adjuvants in epidural anesthesia ensuring satisfactory postoperative period. This study evaluates the effect of dexmedetomidine and fentanyl as additives to bupivacaine for epidural analgesia.
Detailed Description
The aim of the study is to evaluate the effect of dexmedetomidin and fentanyl as adjuvants to bupivacaine for postoperative epidural analgesia in abdominal surgeries regarding block characteristics, post-operative analgesia, hemodynamic changes and any anticipated side effects.
Type of Study: Prospective randomized comparative clinical study.
Study Setting: The operating theatres of Ain Shams University Hospitals
Study Period: One year
Sampling Method: Random sampling Patients randomly allocated by computer generated randomization and using opaque sealed envelopes to one of the three study groups according to the adjuvant drug used in postoperative analgesia.
Sample Size: Total 75 cases divided into 25 cases in each group. Kiran et al. (2018) reported a rather large effect size comparing onset to sensory block and time to maximum motor block. In a one-way ANOVA study, sample sizes of 25 cases per group in three groups whose means are to be compared. The total sample of 75 subjects achieves 80% power to detect differences among the means versus the alternative of equal means using an F test with a 0.0500 significance level. The size of the variation in the means is represented by the effect size = 0.4
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidural Analgesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Other
Arm Description
Normal saline 2 ml will be mixed with 48 ml bupivacaine 0.125% in an elastomeric pump. The rate of epidural infusion will be 5ml/hr for the postoperative 24 hours.
Arm Title
Fentanyl group
Arm Type
Other
Arm Description
Fentanyl 2 ml (100 μg) will be mixed with 48 ml bupivacaine 0.125% in an elastomeric pump. The rate of epidural infusion will be 5ml/hr for the postoperative 24 hours.
Arm Title
Dexmedetomidine group
Arm Type
Other
Arm Description
Dexmedetomidine 1 ml (100 μg) plus 1 ml normal saline will be mixed with 48 ml bupivacaine 0.125% in an elastomeric pump. The rate of epidural infusion will be 5ml/hr for the postoperative 24 hours.
Intervention Type
Drug
Intervention Name(s)
Control Analgesic regimen
Other Intervention Name(s)
Epidural Bupivacaine
Intervention Description
testing the efficiency of bupivacaine without adjuvant drugs in epidural analgesia
Intervention Type
Drug
Intervention Name(s)
Fentanyl Analgesic regimen
Other Intervention Name(s)
Epidural Fentanyl Bupivacaine
Intervention Description
testing the efficiency of Fentanyl as an adjuvant drug to bupivacaine in epidural analgesia
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Analgesic regimen
Other Intervention Name(s)
Epidural Dexmedetomidine Bupivacaine
Intervention Description
testing the efficiency of Dexmedetomidine as an adjuvant drug to bupivacaine in epidural analgesia
Primary Outcome Measure Information:
Title
Onset of sensory analgesia
Description
will be assessed by pin prick and cold application from the start of epidural infusion till scoring 1 at the 3 point scale. Assessment will be done every 5 minutes until the onset of sensory block using a 3-point scale: 0=normal sensation, 1=loss of sensation of pin prick (analgesia), and 2=loss of sensation of touch (anesthesia).
Time Frame
24 hours
Title
Duration of analgesia
Description
time from starting epidural infusion to the time of the first request for additional pain medication
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative pain score
Description
for 24 hours using the Visual Analogue Scale ranging from 0 to 10 (0 - no pain, 10 - worst pain ever) at 0, 2, 6, 12 and 24 hrs after starting epidural infusion.
Time Frame
24 hours
Title
Analgesic consumption
Description
during the 24 hours following epidural infusion.
Time Frame
24 hours
Title
The motor block
Description
will be assessed if occurred by Bromage three point score (0-3) for the lower extremity during the 24 hours following epidural infusion where 0: no motor impairment (able to move the hip, knee, and ankle joints);
unable to raise either extended leg (able to move joints of knee and ankle);
unable to raise extended leg and flex knee (able to move joint of ankle); 3; unable to move knee and foot.
Time Frame
24 hours
Title
Post operative Mean arterial Blood pressure
Description
Mean arterial pressure in mmHg will be monitored continuously and recorded just before the initiation of epidural infusion and thereafter at 2, 6, 12 and 24 hrs. postoperatively during the 24 hours following epidural infusion
Time Frame
24 hours
Title
Post operative Heart rate
Description
Heart rate (HR) in beats per minute (bpm) will be monitored continuously and recorded just before the initiation of epidural infusion and thereafter at 2, 6, 12 and 24 hrs. postoperatively during the 24 hours following epidural infusion
Time Frame
24 hours
Title
Post operative Peripheral oxygen saturation
Description
Peripheral oxygen saturation in blood (SpO2) will be monitored continuously and recorded just before the initiation of epidural infusion and thereafter at 2, 6, 12 and 24 hrs. postoperatively during the 24 hours following epidural infusion
Time Frame
24 hours
Title
Anticipated adverse events
Description
like postoperative nausea and vomiting during the 24 hours from the start of epidural analgesia
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA I or ASA II patients.
Age group: 21-70 years old.
BMI ≤40
Duration of procedure ≤ 180 minutes.
Exclusion Criteria:
Patients with known neurologic and psychiatric illness will be excluded from the study.
Contraindications for epidural anesthesia as patient refusal, bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia
Spine abnormalities.
Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency.
Allergy to any of the drugs used in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim A Ibrahim, MD
Phone
+201208208230
Email
Drhema2010n@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A Saleh, MD
Phone
+201092847049
Email
senomola@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahaa Eldin E Hassan, Professor
Organizational Affiliation
Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hadeel M Abd Elhamid, Professor
Organizational Affiliation
Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed A Saleh, MD
Organizational Affiliation
Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ibrahim A Ibrahim, MD
Organizational Affiliation
Department of Anesthesia, Intensive care and pain management, Ain Shams University.
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim A Ibrahim, MD
First Name & Middle Initial & Last Name & Degree
Mohamed A Saleh, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21897496
Citation
Grewal A. Dexmedetomidine: New avenues. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):297-302. doi: 10.4103/0970-9185.83670. No abstract available.
Results Reference
background
PubMed Identifier
30464585
Citation
Hetta DF, Fares KM, Abedalmohsen AM, Abdel-Wahab AH, Elfadl GMA, Ali WN. Epidural dexmedetomidine infusion for perioperative analgesia in patients undergoing abdominal cancer surgery: randomized trial. J Pain Res. 2018 Oct 30;11:2675-2685. doi: 10.2147/JPR.S163975. eCollection 2018.
Results Reference
background
PubMed Identifier
29643621
Citation
Kiran S, Jinjil K, Tandon U, Kar S. Evaluation of dexmedetomidine and fentanyl as additives to ropivacaine for epidural anesthesia and postoperative analgesia. J Anaesthesiol Clin Pharmacol. 2018 Jan-Mar;34(1):41-45. doi: 10.4103/joacp.JOACP_205_16.
Results Reference
background
PubMed Identifier
28442930
Citation
Mohamad MF, Mohammad MA, Hetta DF, Ahmed EH, Obiedallah AA, Elzohry AAM. Thoracic epidural analgesia reduces myocardial injury in ischemic patients undergoing major abdominal cancer surgery. J Pain Res. 2017 Apr 12;10:887-895. doi: 10.2147/JPR.S122918. eCollection 2017.
Results Reference
background
PubMed Identifier
26006222
Citation
Yousef AA, Salem HA, Moustafa MZ. Effect of mini-dose epidural dexmedetomidine in elective cesarean section using combined spinal-epidural anesthesia: a randomized double-blinded controlled study. J Anesth. 2015 Oct;29(5):708-14. doi: 10.1007/s00540-015-2027-7. Epub 2015 May 26.
Results Reference
background
PubMed Identifier
27513640
Citation
Zhao Y, Xin Y, Liu Y, Yi X, Liu Y. Effect of Epidural Dexmedetomidine Combined With Ropivacaine in Labor Analgesia: A Randomized Double-Blinded Controlled Study. Clin J Pain. 2017 Apr;33(4):319-324. doi: 10.1097/AJP.0000000000000411.
Results Reference
background
Citation
Soliman, Rabie & Eltaweel, Moataz. (2016). Comparative study of dexmedetomidine and fentanyl as an adjuvant to epidural bupivacaine for postoperative pain relief in adult patients undergoing total knee replacement: a randomized study. Journal of Anesthesiology and Clinical Science. 5. 1. 10.7243/2049-9752-5-1.
Results Reference
background
Links:
URL
http://www.nice.org.uk.
Description
National institute for health and clinical excellence
Learn more about this trial
Comparative Study Between Two Adjuvant Drugs to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries
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