Ultrasound Guided Intermediate Cervical Plexus Block in Thyroid Surgery

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03731468
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.5
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

studying the effect of dexmeditomidine addition to bupivacaine in bilateral intermediate cervical block for patients undergoing thyroidectomy under general anaesthesia

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: local anesthetic; Drug: Dexamethasone	N/A

Detailed Description

80 patients who will be undergoing elective thyroidectomy will be randomly allocated into one of two groups ; group A will receive 20 mg isobaric bupivacaine + 8 mg dexamethasone(diluted in 5 ml) group B will receive 20 mg isobaric bupivacaine + 1 ml normal saline. block will be done under complete a septic condition after induction of general anaesthesia.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effect of Dexmethasone Addition to Bupivacaine in Bilateral Intermediate Cervical Block in Thyroid Surgery
• Actual Study Start Date: Sep 15, 2018
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: dexmethasone group 8 mg dexamethasone will be added to local anaesthetics	Drug: Dexamethasone; dexamethasone will be added to ultrasound guided superficial cervical block in thyroid surgery
Sham Comparator: control group isobaric bupivacaine will be given on each side	Drug: local anesthetic; ultrasound guided superficial cervical block in thyroid surgery

Outcome Measures

Primary Outcome Measures

1. postoperative analgesia duration [24 hour postoperative]

   time of first analgesic requirement is the time of end of block analgesia

Secondary Outcome Measures

1. postoperative complications related to the block [8 hours]

   occurrence of complications secondary to the block well be recorded

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Elective surgery

• ASA 1, II, AND III

Exclusion Criteria:

• Patient refusal

• Infection at the entry site

• BMI > 3

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rasha Hamed, clinical professor, Assiut University
• ClinicalTrials.gov Identifier: NCT03731468
• Other Study ID Numbers: UDLC
• First Posted: Nov 6, 2018
• Last Update Posted: Mar 10, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Dexamethasone; Anesthetics; Anesthetics, Local

Study Results

No Results Posted as of Mar 10, 2021