NCT05323214

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

January 21, 2022

Last Update Submit

July 13, 2022

Conditions

Epidural Analgesia

Outcome Measures

Primary Outcomes (2)

  • 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).

    24 hours

  • Duration of analgesia

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

    24 hours

Secondary Outcomes (7)

  • Postoperative pain score

    24 hours

  • Analgesic consumption

    24 hours

  • The motor block

    24 hours

  • Post operative Mean arterial Blood pressure

    24 hours

  • Post operative Heart rate

    24 hours

  • +2 more secondary outcomes

Study Arms (3)

Control group

OTHER

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

Fentanyl group

OTHER

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

Dexmedetomidine group

OTHER

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

Interventions

Control Analgesic regimenDRUG

testing the efficiency of bupivacaine without adjuvant drugs in epidural analgesia

Also known as: Epidural Bupivacaine
Control group
Fentanyl Analgesic regimenDRUG

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

Also known as: Epidural Fentanyl Bupivacaine
Fentanyl group
Dexmedetomidine Analgesic regimenDRUG

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

Also known as: Epidural Dexmedetomidine Bupivacaine
Dexmedetomidine group

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

RECRUITING

Related Publications (7)

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

    PMID: 21897496BACKGROUND

  • 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.

    PMID: 30464585BACKGROUND

  • 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.

    PMID: 29643621BACKGROUND

  • 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.

    PMID: 28442930BACKGROUND

  • 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.

    PMID: 26006222BACKGROUND

  • 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.

    PMID: 27513640BACKGROUND

  • 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.

    BACKGROUND

Related Links

Study Officials

  • Bahaa Eldin E Hassan, Professor

    Department of Anesthesia, Intensive care and pain management, Ain Shams University.

    STUDY CHAIR

  • 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.

    STUDY DIRECTOR

Central Study Contacts

Ibrahim A Ibrahim, MD

CONTACT

+201208208230Drhema2010n@gmail.com

Mohamed A Saleh, MD

CONTACT

+201092847049senomola@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

April 12, 2022

Study Start

August 1, 2021

Primary Completion

August 31, 2022

Study Completion

September 30, 2022

Last Updated

July 15, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)