NCT07838831

Brief Summary

The aim of this study is to compare the analgesic efficacy of Dexmedetomidine and Ketamine as adjuvants to Bupivacaine in ultrasound-guided Bilateral SCPB in patients undergoing thyroidectomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
completed

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 31, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
Last Updated

September 24, 2026

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

September 18, 2026

Last Update Submit

September 18, 2026

Conditions

Keywords

dexmedetomidinethyroidectomyketaminesuperficial cervical plexus bl

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    total 24 hours Morphine consumption(mg)

    24 hours

Secondary Outcomes (1)

  • Assessment of post operative pain

    immediately (T0),15 mins(T1),30 mins(T2),1 hour(T3),2 hours(T4),4 hours(T5)8 hours(T6),12 hours(T7),18 hours(T8),24 hours(T9) after arrival to recovery room

Study Arms (3)

Group C (Control group)

PLACEBO COMPARATOR

Patients will only receive bilateral SCPB with 45mg bupivacaine diluted with normal saline (18 mL; 9 mL on each side) after intubation and before surgical incision.

Drug: Group C (Control group)

Group D (Dexmedetomidine group)

EXPERIMENTAL

Patients will receive general anesthesia plus US guided Bilateral SCPB with 45mg bupivacaine diluted with normal saline to 16mL and 1 μg/kg dexmedetomidine diluted with normal saline to 2mL (total volume, 18 mL; 9 mL on each side) after intubation and before surgical incision.

Drug: Group D (Dexmedetomidine group)

Group K (Ketamine group)

EXPERIMENTAL

Patients will receive general anesthesia plus US guided Bilateral SCPB with 45mg bupivacaine diluted with normal saline to 16 mL and 1 mg/kg ketamine diluted with normal saline to 2 mL (total volume, 18 mL; 9 mL on each side) after intubation and before surgical incision.

Drug: Group K (Ketamine group)

Interventions

Patients will only receive bilateral SCPB with 45mg bupivacaine diluted with normal saline (18 mL; 9 mL on each side) after intubation and before surgical incision.

Group C (Control group)

Patients will receive general anesthesia plus US guided Bilateral SCPB with 45mg bupivacaine diluted with normal saline to 16mL and 1 μg/kg dexmedetomidine diluted with normal saline to 2mL (total volume, 18 mL; 9 mL on each side) after intubation and before surgical incision.

Group D (Dexmedetomidine group)

Patients will receive general anesthesia plus US guided Bilateral SCPB with 45mg bupivacaine diluted with normal saline to 16 mL and 1 mg/kg ketamine diluted with normal saline to 2 mL (total volume, 18 mL; 9 mL on each side) after intubation and before surgical incision.

Group K (Ketamine group)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged more than 18 years
  • American Society of Anesthesiologists physical status I or II
  • scheduled for elective thyroid surgery will be included in the study.

You may not qualify if:

  • Patients who refuse to participate in the study.
  • Patients presented with mental and memory dysfunction.
  • Patients with history of allergy to local anesthetics.
  • Patients with history of chronic use of pain killers )most days for more than 3 months).
  • Patients presented with skin or soft tissue infection at the proposed site of needle.
  • Pre-existing major organ dysfunction such as hepatic or renal impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 24, 2026

Study Start

August 31, 2025

Primary Completion

August 30, 2026

Study Completion

August 30, 2026

Last Updated

September 24, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

It will be available if it needed

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations