Comparative Study Between Two Adjuvant Drugs to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries

July 13, 2022 updated by: Ain Shams University

Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University Hospitals
        • Contact:
          • Ibrahim A Ibrahim, MD
        • Contact:
          • Mohamed A Saleh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Control group
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.
Drug: Control Analgesic regimen
testing the efficiency of bupivacaine without adjuvant drugs in epidural analgesia
Other Names:
  • Epidural Bupivacaine
OTHER: Fentanyl group
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.
Drug: Fentanyl Analgesic regimen
testing the efficiency of Fentanyl as an adjuvant drug to bupivacaine in epidural analgesia
Other Names:
  • Epidural Fentanyl Bupivacaine
OTHER: Dexmedetomidine group
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.
Drug: Dexmedetomidine Analgesic regimen
testing the efficiency of Dexmedetomidine as an adjuvant drug to bupivacaine in epidural analgesia
Other Names:
  • Epidural Dexmedetomidine Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of sensory analgesia
Time Frame: 24 hours
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).
24 hours
Duration of analgesia
Time Frame: 24 hours
time from starting epidural infusion to the time of the first request for additional pain medication
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain score
Time Frame: 24 hours
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.
24 hours
Analgesic consumption
Time Frame: 24 hours
during the 24 hours following epidural infusion.
24 hours
The motor block
Time Frame: 24 hours

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);

  1. unable to raise either extended leg (able to move joints of knee and ankle);
  2. unable to raise extended leg and flex knee (able to move joint of ankle); 3; unable to move knee and foot.
24 hours
Post operative Mean arterial Blood pressure
Time Frame: 24 hours
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
24 hours
Post operative Heart rate
Time Frame: 24 hours
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
24 hours
Post operative Peripheral oxygen saturation
Time Frame: 24 hours
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
24 hours
Anticipated adverse events
Time Frame: 24 hours
like postoperative nausea and vomiting during the 24 hours from the start of epidural analgesia
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Bahaa Eldin E Hassan, Professor, Department of Anesthesia, Intensive care and pain management, Ain Shams University.
  • Study Director: Hadeel M Abd Elhamid, Professor, Department of Anesthesia, Intensive care and pain management, Ain Shams University.
  • Study Director: Mohamed A Saleh, MD, Department of Anesthesia, Intensive care and pain management, Ain Shams University.
  • Study Director: Ibrahim A Ibrahim, MD, Department of Anesthesia, Intensive care and pain management, Ain Shams University.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2021

Primary Completion (ANTICIPATED)

August 31, 2022

Study Completion (ANTICIPATED)

September 30, 2022

Study Registration Dates

First Submitted

January 21, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (ACTUAL)

April 12, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD 121/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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