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CompletedNCT05180214Updated Jan 21, 2022

Analgesia for Thyroidectomy Using Bilateral Superficial Cervical Plexus Block With Bupivacaine Only or Adding Ketorolac to it.

A Phase 2 interventional study of Bupivacain and Ketorolac in Thyroid Goiter and Thyroid Nodule, sponsored by Sohag University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-01-21.

Sponsored by Sohag University · Phase 2, Interventional, and Health services research

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jan 2021, registered Dec 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

Thyroidectomy is considered a common operation with moderate to severe postoperative pain in some patients. Patients are divided into two groups. Bupivacaine group received bilateral superficial cervical plexus block (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of normal saline on each side and the Bupivacaine Ketorolac group received (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of ketorolac (15 mg) on each side.

02

Conditions studied

  • Thyroid Goiter
  • Thyroid Nodule

Keywords

  • ketorolac, superficial cervical plexus block, thyroidectomy
03

In context

Goiter

66 studies on the registry are indexed under Goiter; 11 are open to participants now.

This study's enrollment of 46 is below the median of 100 across 42 interventional studies indexed under Goiter.

Browse Goiter studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 20-50 years
  • patients
  • Patients going to do thyroid surgeries under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • Patient refusal
  • Known history of sensitivity to the drug used in the study
  • Drug abuse
  • Infection at the site of the block
  • Presence of coagulopathy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    bupivacaine

    Drug: Bupivacain

  • Active comparator
    bupivacaine and ketorolac

    Drug: Bupivacain · Drug: Ketorolac

Interventions

06

What researchers measure

Primary outcomes

  1. 1st analgesic requirement

    The first time of supplemental analgesic need postoperatively

    Time frame: 24 hours

Secondary outcomes

  1. analgesic consumption

    total analgesic consumption

    Time frame: 24 hours

  2. postoperative pain

    visual analogue scale(0-10) 0=no pain and 10=severe intolerable pain

    Time frame: 24 hours

07

Study locations

1 site
  • Sohag University Faculty of Medicine
    Sohag, 52514, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05180214
Lead sponsor
Sohag University
Responsible party
Fouad Soliman (Lectuerer of Anesthesia and ICU, Sohag University) — Principal investigator
First posted
Jan 6, 2022
Start date
Jan 17, 2021
Primary completion
Aug 19, 2021
Completion
Sep 15, 2021
Last update
Jan 21, 2022

Oversight

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

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ketorolac

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