CClinicalTrials.gg
Not yet recruitingNCT06752629Updated Dec 31, 2024

Comparison Between Dexmedetomidine and Fentanyl As an Adjuvant to Bupivacaine in the Paravertebral Nerve Block in Laparoscopic Cholecystectomy for Postoperative Analgesia: Randomized Comparative Clinical Trial.

A Phase 4 interventional study of Bupivacaine and Dexmedetomidine and Bupivacaine and Fentanyl in Laparoscopic Cholecystectomy, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-31.

Sponsored by Assiut University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Laparoscopic cholecystectomy is one of the most common surgeries today, cause it has many advantages over open cholecystectomy. Although these advantages pain remains a big problem after laparoscopic cholecystectomy which causes patient admission or readmission. This post-operative laparoscopic cholecystectomy pain causes extreme patient discomfort, extended post-anesthesia care unit stay and restricts early recovery.

To overcome this problem, there were trials of inta abdominal instillation with local anesthetics with no positive results , so they combined this with local infiltration at the laparoscopic access sites with no satisfactory postoperative analgesia.

The aim of this study is to evaluate the effect and the difference between dexmedetomidine and fentanyl in pre-operative unilateral (T5\&6) thoracic paravertebral block for postoperative analgesia in laparoscopic cholecystectomy

Read the detailed description

The para-vertebral block has been largely used over the past years for post-operative analgesia. Many reports in the literature describe the use of thoracic paravertebral block for providing post-laparoscopic cholecystectomy analgesia. Thanks to the ultrasound, over the past years, paravertebral blocks (PVB) have been increasingly used for providing postoperative analgesia, and in the administration of thoracic paravertebral block which has greatly reduced the incidence of associated complications.

Contrary to the intra-abdominal instillation of local anesthetics and local infiltration, the paravertebral blockade has been reported to provide high-quality afferent blockade with the abolishment of somatosensory evoked potentials. and has also been found capable of attenuating the postoperative stress response associated with traditional cholecystectomy.

02

Conditions studied

  • Laparoscopic Cholecystectomy

Keywords

  • paravertebral nerve block
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult patients within age; (18-60)
  • Body mass index (BMI); (18-30)
  • ASA I - II

Exclusion criteria

Exclusion Criteria:

  • ● Patient refusal to participate in the study

    • Allergy to local anesthetics
    • Coagulopathy
    • Morbid obesity
    • Decreased pulmonary reserve
    • Cardiac disorder
    • Renal dysfunction
    • Pre-existing neurological deficit
    • Psychiatric illness
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    group 1

    Adult patients will take 10 ml Bupivacaine 0.5% plus 2ml solution of Dexmedetomidine 1mic/kg in the bilateral T5\&6 preoperatively

    Drug: Bupivacaine and Dexmedetomidine

  • Experimental
    group 2

    Adult patients will take 10 ml Bupivacaine 0.5% plus 2ml solution of Fentanyl 20 microgram with the bilateral T5\&6 preoperatively.

    Drug: Bupivacaine and Fentanyl

Interventions

  • DrugBupivacaine and Dexmedetomidine

    Adult patients will take 10 ml Bupivacaine 0.5% plus 2ml solution of Dexmedetomidine 1mic/kg in the bilateral T5\&6 preoperatively

  • DrugBupivacaine and Fentanyl

    Adult patients will take 10 ml Bupivacaine 0.5% plus 2ml solution of Fentanyl 20 microgram with the bilateral T5\&6 preoperatively

06

What researchers measure

Primary outcomes

  1. level of sensory block duration

    We will evaluate the sensory block by counting the number of dermatomes at regular intervals . Dermatome regression will be used as a marker of sensory block.

    Time frame: 48 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06752629
Lead sponsor
Assiut University
Responsible party
Eithar Mahmoud Abd-Elsalm (resident doctor at Assiut University hospital, Assiut University) — Principal investigator
First posted
Dec 31, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Jan 1, 2026 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Dec 31, 2024

Study contacts

Eithar Mahmoud Abd-Elsalm, resident doctor
Contact
ethar.16266036@med.aun.edu.eg
+201220805991

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion