ThyroidectomyNCT07838831
Ketamine Versus Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound Guided Bilateral Superficial Cervical Plexus Block in Thyroidectomy
A study testing Group D (Dexmedetomidine group) and Group K (Ketamine group) in people with Thyroidectomy and Bupivacaine, run by Tanta University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thyroidectomy, Bupivacaine, Dexmedetomidine
- What is being tested?
- Group D (Dexmedetomidine group) and Group K (Ketamine group)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Aug 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketamine Versus Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound Guided Bilateral Superficial Cervical Plexus Block in Patients Undergoing Thyroidectomy: a Prospective Randomized Controlled Study
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
Read the detailed description
Thyroid gland disorders are relatively widespread. These conditions encompass a range of issues, including hypothyroidism, hyperthyroidism, goiter, thyroid nodules, thyroiditis, and various forms of thyroid cancer. While some thyroid conditions can be effectively managed through medical treatment alone, surgical intervention - particularly thyroidectomy - continues to play a central role in addressing both benign and malignant thyroid diseases.
Despite being a relatively safe operation, various complications can occur including postoperative pain, which remains a significant concern affecting patient comfort, recovery, and overall satisfaction.
Poorly controlled postoperative pain may result in adverse events that may prolong the patient's hospital stay, delay patient recovery, and affect the patient's experience with the health care system.
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 Adequate postoperative pain management is essential for enhancing functional recovery, promoting early mobilization, and facilitating timely discharge from the hospital.
Post thyroidectomy pain may be treated with medical treatment like acetaminophen , non steroidal anti inflammatory drugs or opioids. However, many surgeons are reluctant to use NSAIDs so soon after the procedure because of gastric upset and bleeding disorders , also can be treated by local infiltration or regional block.
Opioids are commonly administered to relieve postoperative pain; however, their use is often associated with undesirable side effects such as nausea, vomiting, and respiratory depression. Effective management of postoperative pain is a crucial factor in ensuring a high quality of recovery following surgery. Ultrasound -guided superficial cervical plexus block offers several key advantages. These include real-time visualization of anatomical structures, the use of reduced volumes of local anesthetics, and a lower risk of inadvertent vascular injury or accidental puncture.
Due to its practicality and effectiveness, ultrasound-guided bilateral superficial cervical plexus block has become a valuable technique for providing effective regional analgesia during thyroidectomy, contributing to improved patient recovery. Ketamine and dexmedetomidine are two promising adjuvants that have been studied extensively in regional anesthesia due to their distinct yet complementary mechanisms of action. ketamine, a non-competitive N-methyl-D-aspartate receptor antagonist, attenuates central sensitization and hyperalgesia, thereby extending the duration of peripheral nerve blocks. Its role in reducing opioid consumption and preventing chronic post-surgical pain has been well-documented. Dexmedetomidine, a highly selective α-2 adrenergic agonist, exerts its analgesic effects through both peripheral and central mechanisms, including inhibition of nociceptive neurotransmission and sympathetic outflow. There is no study uptill now comparing the analgesic effect of dexmedetomidine and ketamine as an adjuvants in ultrasound guided bilateral superficial cervical plexus block for more hemodynamics satability.
- Conditions
- Thyroidectomy, Bupivacaine, Dexmedetomidine
- Being tested
- Group C (Control group), Group D (Dexmedetomidine group), Group K (Ketamine group)
- Keywords
- dexmedetomidine, thyroidectomy, ketamine, superficial cervical plexus bl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group C (Control group)Drug
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 D (Dexmedetomidine group)Drug
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 K (Ketamine group)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Group K (Ketamine group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
total 24 hours Morphine consumption(mg)
Measured: 24 hours
Secondary outcomes (1)
Assessment of post operative pain
Assessment of post operative pain using the Visual Analogue Scale ( (a mark was made along the 10-cm line, where the marks at 0 and 10 cm represent no pain and the worst pain)
Measured: immediately (T0),15 minutes(T1),30 minutes(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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start31 Aug 2025
- Primary completion30 Aug 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdulhamid Sroor Abdulhamid Eissa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838831
- Sponsor's protocol ID
- 36264MS1012/7/25
- Status last verified
- Aug 2025
- First submitted
- 18 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available if it needed
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Versus Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound Guided Bilateral Superficial Cervical Plexus Block in Patients Undergoing Thyroidectomy: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07838831
- Acronym / sponsor ID
- 36264MS1012/7/25
- Conditions
- Thyroidectomy, Bupivacaine, Dexmedetomidine
- Keywords
- dexmedetomidine, thyroidectomy, ketamine, superficial cervical plexus bl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Thyroid gland disorders are relatively widespread. These conditions encompass a range of issues, including hypothyroidism, hyperthyroidism, goiter, thyroid nodules, thyroiditis, and various forms of thyroid cancer. While some thyroid conditions can be effectively managed through medical treatment alone, surgical intervention - particularly thyroidectomy - continues to play a central role in addressing both benign and malignant thyroid diseases.
Despite being a relatively safe operation, various complications can occur including postoperative pain, which remains a significant concern affecting patient comfort, recovery, and overall satisfaction.
Poorly controlled postoperative pain may result in adverse events that may prolong the patient's hospital stay, delay patient recovery, and affect the patient's experience with the health care system.
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 Adequate postoperative pain management is essential for enhancing functional recovery, promoting early mobilization, and facilitating timely discharge from the hospital.
Post thyroidectomy pain may be treated with medical treatment like acetaminophen , non steroidal anti inflammatory drugs or opioids. However, many surgeons are reluctant to use NSAIDs so soon after the procedure because of gastric upset and bleeding disorders , also can be treated by local infiltration or regional block.
Opioids are commonly administered to relieve postoperative pain; however, their use is often associated with undesirable side effects such as nausea, vomiting, and respiratory depression. Effective management of postoperative pain is a crucial factor in ensuring a high quality of recovery following surgery. Ultrasound -guided superficial cervical plexus block offers several key advantages. These include real-time visualization of anatomical structures, the use of reduced volumes of local anesthetics, and a lower risk of inadvertent vascular injury or accidental puncture.
Due to its practicality and effectiveness, ultrasound-guided bilateral superficial cervical plexus block has become a valuable technique for providing effective regional analgesia during thyroidectomy, contributing to improved patient recovery. Ketamine and dexmedetomidine are two promising adjuvants that have been studied extensively in regional anesthesia due to their distinct yet complementary mechanisms of action. ketamine, a non-competitive N-methyl-D-aspartate receptor antagonist, attenuates central sensitization and hyperalgesia, thereby extending the duration of peripheral nerve blocks. Its role in reducing opioid consumption and preventing chronic post-surgical pain has been well-documented. Dexmedetomidine, a highly selective α-2 adrenergic agonist, exerts its analgesic effects through both peripheral and central mechanisms, including inhibition of nociceptive neurotransmission and sympathetic outflow. There is no study uptill now comparing the analgesic effect of dexmedetomidine and ketamine as an adjuvants in ultrasound guided bilateral superficial cervical plexus block for more hemodynamics satability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C (Control group) | Placebo comparator | Drug: Group C (Control group)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 D (Dexmedetomidine group) | Experimental | Drug: Group D (Dexmedetomidine 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 K (Ketamine group) | Experimental | Drug: Group K (Ketamine 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group C (Control group)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)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)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) |
Primary outcome
Morphine consumption
Time frame: 24 hours
total 24 hours Morphine consumption(mg)
1 secondary outcome
Assessment of post operative pain
Time frame: immediately (T0),15 minutes(T1),30 minutes(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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. It will be available if it needed
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Comparison of Post-operative Outcomes Between ERAS Protocol and Non-ERAS Local Regimen in Patients Undergoing Thyroidectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group D (Dexmedetomidine group) and Group K (Ketamine group) in people with Thyroidectomy and Bupivacaine, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.