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

• Sponsor: Sohag University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05180214
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.9
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Goiter; Thyroid Nodule	Drug: Bupivacain; Drug: Ketorolac	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: The Effect of Adding Ketorolac to Bupivacaine in Superficial Cervical Plexus Block in Thyroid Surgery.
• Actual Study Start Date: Jan 17, 2021
• Actual Primary Completion Date: Aug 19, 2021
• Actual Study Completion Date: Sep 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: bupivacaine	Drug: Bupivacain; analgesic
Active Comparator: bupivacaine and ketorolac	Drug: Bupivacain; analgesic; Drug: Ketorolac; analgesia

Outcome Measures

Primary Outcome Measures

1. 1st analgesic requirement [24 hours]

   The first time of supplemental analgesic need postoperatively

Secondary Outcome Measures

1. analgesic consumption [24 hours]

   total analgesic consumption

2. postoperative pain [24 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients aged 20-50 years

• ASA I-II patients

• Patients going to do thyroid surgeries under general anesthesia

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag University Faculty of Medicine	Sohag		Egypt	52514

Sponsors and Collaborators

• Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fouad Soliman, Lectuerer of Anesthesia and ICU, Sohag University
• ClinicalTrials.gov Identifier: NCT05180214
• Other Study ID Numbers: 2006
• First Posted: Jan 6, 2022
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fouad Soliman, Lectuerer of Anesthesia and ICU, Sohag University: ketorolac, superficial cervical plexus block, thyroidectomy
• Additional relevant MeSH terms: Thyroid Nodule; Thyroid Diseases; Goiter; Ketorolac; Bupivacaine

Study Results

No Results Posted as of Jan 21, 2022