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Epidural AnalgesiaPhase 4NCT05323214

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

A Phase 4 study testing Fentanyl Analgesic regimen and Dexmedetomidine Analgesic regimen in people with Epidural Analgesia, run by Ain Shams University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Epidural Analgesia
What is being tested?
Fentanyl Analgesic regimen and Dexmedetomidine Analgesic regimen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteEgypt
Study dates
1 Aug 2021to 30 Sep 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ASA I or ASA II patients.
  • Age group: 21-70 years old.
  • BMI ≤40
  • Duration of procedure ≤ 180 minutes.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Ibrahim A Ibrahim, MD contact

+201208208230

Drhema2010n@gmail.com

Mohamed A Saleh, MD contact

+201092847049

senomola@gmail.com

Egypt1 site, 1 recruiting

  • Ain Shams University Hospitals

    Cairo

    Ibrahim A Ibrahim, MD

    Mohamed A Saleh, MD

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Read the 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
Being tested
Control Analgesic regimen, Fentanyl Analgesic regimen, Dexmedetomidine Analgesic regimen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control Analgesic regimenDrug

    Also called Epidural Bupivacaine

    testing the efficiency of bupivacaine without adjuvant drugs in epidural analgesia

  • Fentanyl Analgesic regimenDrug

    Also called Epidural Fentanyl Bupivacaine

    testing the efficiency of Fentanyl as an adjuvant drug to bupivacaine in epidural analgesia

  • Dexmedetomidine Analgesic regimenDrug

    Also called Epidural Dexmedetomidine Bupivacaine

    testing the efficiency of Dexmedetomidine as an adjuvant drug to bupivacaine in epidural analgesia

Study groups in NCT05323214
Study groupRoleWhat they receive
Control groupOtherNormal 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.
Receives: Drug: Control Analgesic regimen
Fentanyl groupOtherFentanyl 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.
Receives: Drug: Fentanyl Analgesic regimen
Dexmedetomidine groupOtherDexmedetomidine 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.
Receives: Drug: Dexmedetomidine Analgesic regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 24 hours

  2. Duration of analgesia

    time from starting epidural infusion to the time of the first request for additional pain medication

    Measured: 24 hours

Secondary outcomes (7)

  1. 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.

    Measured: 24 hours

  2. Analgesic consumption

    during the 24 hours following epidural infusion.

    Measured: 24 hours

  3. 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);

    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.

    Measured: 24 hours

  4. 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

    Measured: 24 hours

  5. 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

    Measured: 24 hours

  6. 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

    Measured: 24 hours

  7. Anticipated adverse events

    like postoperative nausea and vomiting during the 24 hours from the start of epidural analgesia

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start1 Aug 2021
  3. Primary completion31 Aug 2022 (estimated)
  4. Study completion30 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05323214
Sponsor's protocol ID
FMASU MD 121/2021
Status last verified
Jul 2022
First submitted
21 Jan 2022
Last updated
15 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Grewal A. Dexmedetomidine: New avenues. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):297-302. doi: 10.4103/0970-9185.83670. No abstract available.

    PubMed 21897496

  • 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.

    PubMed 30464585

  • 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.

    PubMed 29643621

  • 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.

    PubMed 28442930

  • 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.

    PubMed 26006222

  • 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.

    PubMed 27513640

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fentanyl Analgesic regimen and Dexmedetomidine Analgesic regimen in people with Epidural Analgesia, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ibrahim A Ibrahim, MD (+201208208230, Drhema2010n@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Onset of sensory analgesia (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05323214, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.

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