Uterine Fibroids (Leiomyoma)NCT07860203
Stellate Ganglion Block and Dexmedetomidine for Postoperative Sleep in Women Undergoing Laparoscopic Gynecologic Surgery
A study testing DEX 0.2 μg/kg/h. and SGB in people with Uterine Fibroids (Leiomyoma) and Adenomyosis of Uterus, run by Catherin Zhang at 1 site in China.
Trial summary
Study Objectives This study aims to investigate the effects of preoperative stellate ganglion block and intraoperative intravenous dexmedetomidine on postoperative sleep disturbance in patients undergoing laparoscopic gynecologic surgery, with the goals of reducing pain and postoperative adverse reactions and… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Uterine Fibroids (Leiomyoma), Adenomyosis of Uterus, Endometriosis
- What is being tested?
- DEX 0.2 μg/kg/h. and SGB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with American Society of Anesthesiologists (ASA) physical status I-III;
- Age 18-75 years;
- Scheduled to undergo laparoscopic gynecologic surgery (laparoscopic hysterectomy or laparoscopic surgery for uterine fibroids).
Who cannot join
- Preoperative sore throat or hoarseness;
- History of upper respiratory tract infection within the previous 2 weeks;
- Anticipated difficult tracheal intubation (Mallampati class III or IV, potential facial deformity, mouth opening <3 finger breadths, etc.);
- Severe preoperative cardiac, hepatic, renal, or other organ dysfunction;
- Allergy to the local anesthetic used in the study, infection at the puncture site, or coagulation abnormalities;
- Cognitive impairment, hearing impairment, language impairment, a history of psychiatric illness, or difficulty communicating or cooperating because of a psychiatric disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huai'an Second People's Hospital
Huai'an, Jiangsu, 223001
About this study
Official title: Effects of Stellate Ganglion Block Combined With Dexmedetomidine on Postoperative Sleep Quality in Patients Undergoing Laparoscopic Gynecological Surgery: A Randomized Controlled 2×2 Factorial Trial
Study Objectives This study aims to investigate the effects of preoperative stellate ganglion block and intraoperative intravenous dexmedetomidine on postoperative sleep disturbance in patients undergoing laparoscopic gynecologic surgery, with the goals of reducing pain and postoperative adverse reactions and identifying an effective, safe, economical, and broadly applicable intervention strategy that may facilitate emergence from anesthesia, accelerate postoperative recovery, shorten the length of hospital stay, and reduce hospitalization costs.
This trial aims to determine whether preoperative stellate ganglion block (SGB) and intraoperative intravenous dexmedetomidine (DEX) can improve postoperative sleep quality in patients undergoing laparoscopic gynecologic surgery, and whether the combination of these two interventions provides an interaction effect or additional ben
- Conditions
- Uterine Fibroids (Leiomyoma), Adenomyosis of Uterus, Endometriosis, Endometrial Cancer, Cervical Cancer, Ovarian Cancer
- Being tested
- DEX 0.2 μg/kg/h., SGB, 0.9% Sodium Chloride (Placebo), Sham Stellate Ganglion Block
- Medical subject headings
- Leiomyoma, Adenomyosis, Endometriosis, Endometrial Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEX 0.2 μg/kg/h.Drug
Dexmedetomidine is administered by intravenous infusion after induction of anesthesia without a loading dose, at an infusion rate of 0.2μg·kg-¹·h-¹, and continued until the end of surgery.
SGBProcedure or surgery
Stellate ganglion block (SGB) is performed 15 min after induction of anesthesia by an anesthesiologist experienced in ultrasound-guided regional anesthesia, who is aware of the patient's group assignment. The patient is placed in the supine position with the neck slightly extended and rotated to the contralateral side. Under sterile conditions, a high-frequency linear-array ultrasound transducer is used to scan the anterior neck transversely at the C6 level, sequentially identifying the common carotid artery, internal jugular vein, thyroid gland, esophagus, C6 transverse process and anterior tubercle, longus colli muscle, and surrounding vascular structures.
In the SGB group, an in-plane needle approach is used under real-time ultrasound guidance. After the needle tip reaches the fascial plane anterior to the longus colli muscle and negative aspiration for blood is confirmed, 5 mL of 0.375% ropivacaine is injected slowly. Spread of the local anesthetic along the surface of the longus
0.9% Sodium Chloride (Placebo)Drug
An equal volume of 0.9% sodium chloride solution is administered by intravenous infusion after induction of anesthesia as a placebo for dexmedetomidine and continued until the end of surgery.
Sham Stellate Ganglion BlockProcedure or surgery
Participants are placed in the same position as those receiving the stellate ganglion block, and the ultrasound probe is placed on the neck in an identical manner to simulate the procedure. No needle puncture or drug injection is performed.
| Study group | Role | What they receive |
|---|---|---|
| Stellate Ganglion Block + Dexmedetomidine | Experimental | Stellate ganglion block + dexmedetomidine Receives: Drug: DEX 0.2 μg/kg/h.; Procedure: SGB |
| Stellate Ganglion Block + Placebo | Experimental | Stellate ganglion block + 0.9% sodium chloride Receives: Procedure: SGB; Drug: 0.9% Sodium Chloride (Placebo) |
| Sham Stellate Ganglion Block + Dexmedetomidine | Experimental | Sham stellate ganglion block + dexmedetomidine Receives: Drug: DEX 0.2 μg/kg/h.; Procedure: Sham Stellate Ganglion Block |
| Sham Stellate Ganglion Block + Placebo | Placebo comparator | Sham stellate ganglion block + 0.9% sodium chloride Receives: Drug: 0.9% Sodium Chloride (Placebo); Procedure: Sham Stellate Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
St. Mary's Hospital Sleep Questionnaire Score 1 Day Before Surgery
Subjective sleep quality is assessed using the St. Mary's Hospital Sleep Questionnaire (SMHSQ). The total score ranges from 11 to 37, with higher scores indicating poorer sleep quality.
Measured: 1 day before surgery（ΡRE）
Total Sleep Time 1 Day Before Surgery
Total sleep time (TST), expressed in minutes, is objectively measured using a Fitbit Charge 6 wrist-worn device.
Measured: 1 day before surgery（PRE）
Wake After Sleep Onset 1 Day Before Surgery
Wake after sleep onset is the total duration of wakefulness after initial sleep onset during the assessed sleep period, measured in minutes using a Fitbit Charge 6 wrist-worn device.
Measured: 1 day before surgery（PRE）
Sleep Efficiency 1 Day Before Surgery
Sleep efficiency is calculated as total sleep time (TST) divided by the sum of total sleep time and wake after sleep onset (WASO), multiplied by 100. TST and WASO are obtained using a Fitbit Charge 6 wrist-worn device. Values range from 0% to 100%, with higher values indicating a greater proportion of the assessed sleep period spent asleep.
Measured: 1 day before surgery(PRE)
St. Mary's Hospital Sleep Questionnaire Score on Postoperative Day 1
Subjective sleep quality is assessed using the St. Mary's Hospital Sleep Questionnaire (SMHSQ). The total score ranges from 11 to 37, with higher scores indicating poorer sleep quality.
Measured: Postoperative Day 1（POD1）
Total Sleep Time on Postoperative Day 1
Total sleep time (TST), expressed in minutes, is objectively measured using a Fitbit Charge 6 wrist-worn device.
Measured: Postoperative day 1
Wake After Sleep Onset on Postoperative Day 1
Wake after sleep onset is the total duration of wakefulness after initial sleep onset during the assessed sleep period, measured in minutes using a Fitbit Charge 6 wrist-worn device.
Measured: Postoperative day 1（ΡOD1)
Sleep Efficiency on Postoperative Day 1
Sleep efficiency is calculated as total sleep time (TST) divided by the sum of total sleep time and wake after sleep onset (WASO), multiplied by 100. TST and WASO are obtained using a Fitbit Charge 6 wrist-worn device. Values range from 0% to 100%, with higher values indicating a greater proportion of the assessed sleep period spent asleep.
Measured: Postoperative day 1(ΡOD1)
St. Mary's Hospital Sleep Questionnaire Score on Postoperative Day 2
Subjective sleep quality is assessed using the St. Mary's Hospital Sleep Questionnaire (SMHSQ). The total score ranges from 11 to 37, with higher scores indicating poorer sleep quality.
Measured: Postoperative Day 2（ΡOD2）
Total Sleep Time on Postoperative Day 2
Total sleep time (TST), expressed in minutes, is objectively measured using a Fitbit Charge 6 wrist-worn device.
Measured: Postoperative day 2
Wake After Sleep Onset on Postoperative Day 2
Wake after sleep onset is the total duration of wakefulness after initial sleep onset during the assessed sleep period, measured in minutes using a Fitbit Charge 6 wrist-worn device.
Measured: Postoperative day 2(POD2)
Sleep Efficiency on Postoperative Day 2
Sleep efficiency is calculated as total sleep time (TST) divided by the sum of total sleep time and wake after sleep onset (WASO), multiplied by 100. TST and WASO are obtained using a Fitbit Charge 6 wrist-worn device. Values range from 0% to 100%, with higher values indicating a greater proportion of the assessed sleep period spent asleep.
Measured: Postoperative day 2(POD2)
Secondary outcomes (19)
Postoperative Pain Intensity at 6 Hours
Postoperative pain intensity is assessed using the Visual Analog Scale. Scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: 6 hours after surgery
Postoperative Pain Intensity at 24 Hours
Postoperative pain intensity is assessed using the Visual Analog Scale. Scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: 24 hours after surgery
Postoperative Pain Intensity at 48 Hours
Postoperative pain intensity is assessed using the Visual Analog Scale. Scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: 48 hours after surgery
Total Intraoperative Sufentanil Consumption
The cumulative dose of sufentanil administered to each participant from induction of anesthesia to the end of surgery is recorded in micrograms.
Measured: From induction of anesthesia to the end of surgery
Total Intraoperative Remifentanil Consumption
The cumulative dose of remifentanil administered to each participant from induction of anesthesia to the end of surgery is recorded in milligrams.
Measured: From induction of anesthesia to the end of surgery
Number of Rescue Analgesia Administrations
The total number of rescue analgesia administrations received by each participant during the first 48 hours after surgery is recorded.
Measured: From the end of surgery to 48 hours after surgery.
Mean Arterial Pressure
Mean arterial pressure (MAP), expressed in mmHg, is recorded at five prespecified time points to assess perioperative hemodynamic changes.
Measured: Before induction of anesthesia (T0), at skin incision (T1), 30 minutes after the start of surgery (T2), 60 minutes after the start of surgery (T3), and at the end of surgery (T4).
Heart Rate
Heart rate (HR), expressed in beats per minute, is recorded at five prespecified time points to assess perioperative hemodynamic changes.
Measured: Before induction of anesthesia (T0), at skin incision (T1), 30 minutes after the start of surgery (T2), 60 minutes after the start of surgery (T3), and at the end of surgery (T4).
Number of Participants With Local Anesthetic Systemic Toxicity
The number of participants who experience local anesthetic systemic toxicity is recorded. Each participant is counted once, regardless of the number of episodes.
Measured: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Puncture-Site Hematoma
The number of participants who develop a puncture-site hematoma is recorded. Each participant is counted once, regardless of the number of episodes.
Measured: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Puncture-Site Infection
The number of participants who develop a puncture-site infection is recorded. Each participant is counted once, regardless of the number of episodes.
Measured: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Unintended Nerve Block
The number of participants who experience an unintended nerve block is recorded. Each participant is counted once, regardless of the number of episodes.
Measured: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Pneumothorax
The number of participants who develop pneumothorax is recorded. Each participant is counted once, regardless of the number of episodes.
Measured: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Bradycardia
The number of participants who experience bradycardia is recorded. Each participant is counted once, regardless of the number of episodes.
Measured: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Hypotension
The number of participants who experience hypotension is recorded. Each participant is counted once, regardless of the number of episodes.
Measured: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Hypoxemia
The number of participants who experience hypoxemia is recorded. Each participant is counted once, regardless of the number of episodes.
Measured: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Postoperative Nausea or Vomiting
The number of participants who experience nausea, vomiting, or both during the first 48 hours after surgery is recorded. Each participant is counted once, regardless of the number of episodes or whether both symptoms occur.
Measured: From the end of surgery to 48 hours after surgery.
Number of Participants With Postoperative Headache or Dizziness
The number of participants who experience headache, dizziness, or both during the first 48 hours after surgery is recorded. Each participant is counted once, regardless of the number of episodes or whether both symptoms occur.
Measured: From the end of surgery to 48 hours after surgery.
Number of Participants With Postoperative Nightmares or Excessive Dreaming
The number of participants who report nightmares, excessive dreaming, or both during the first 48 hours after surgery is recorded. Each participant is counted once, regardless of the number of episodes or whether both symptoms occur.
Measured: From the end of surgery to 48 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Uterine Fibroids (Leiomyoma)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catherin Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Catherin Zhang, The Second People's Hospital of Huai'an
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860203
- Sponsor's protocol ID
- 513
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang RZ, Li YZ, Liang M, Yu JJ, Chen ML, Qiu JJ, Lin SZ, Wu XD, Zeng K. Stellate Ganglion Block Improves Postoperative Sleep Quality and Analgesia in Patients with Breast Cancer: A Randomized Controlled Trial. Pain Ther. 2023 Apr;12(2):491-503. doi: 10.1007/s40122-022-00473-y. Epub 2023 Jan 18.
PubMed 36652140Goel V, Patwardhan AM, Ibrahim M, Howe CL, Schultz DM, Shankar H. Complications associated with stellate ganglion nerve block: a systematic review. Reg Anesth Pain Med. 2019 Apr 16:rapm-2018-100127. doi: 10.1136/rapm-2018-100127. Online ahead of print.
PubMed 30992414Lipov EG, Joshi JR, Sanders S, Wilcox K, Lipov S, Xie H, Maganini R, Slavin K. Effects of stellate-ganglion block on hot flushes and night awakenings in survivors of breast cancer: a pilot study. Lancet Oncol. 2008 Jun;9(6):523-32. doi: 10.1016/S1470-2045(08)70131-1. Epub 2008 May 15.
PubMed 18485819Kjolhede P, Langstrom P, Nilsson P, Wodlin NB, Nilsson L. The impact of quality of sleep on recovery from fast-track abdominal hysterectomy. J Clin Sleep Med. 2012 Aug 15;8(4):395-402. doi: 10.5664/jcsm.2032.
PubMed 22893770Manandhar T, Sitaula S, Thapa BD, Agrawal A, Thakur A. Prevalence of Hysterectomy among Gynecological Surgeries in a Tertiary Care Hospital. JNMA J Nepal Med Assoc. 2020 Dec 31;58(232):965-970. doi: 10.31729/jnma.5315.
PubMed 34506386
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
- Effects of Stellate Ganglion Block Combined With Dexmedetomidine on Postoperative Sleep Quality in Patients Undergoing Laparoscopic Gynecological Surgery: A Randomized Controlled 2×2 Factorial Trial
- ClinicalTrials.gov ID
- NCT07860203
- Acronym / sponsor ID
- 513
- Conditions
- Uterine Fibroids (Leiomyoma), Adenomyosis of Uterus, Endometriosis, Endometrial Cancer, Cervical Cancer, Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Catherin ZhangUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 6 Oct 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.
Study Objectives This study aims to investigate the effects of preoperative stellate ganglion block and intraoperative intravenous dexmedetomidine on postoperative sleep disturbance in patients undergoing laparoscopic gynecologic surgery, with the goals of reducing pain and postoperative adverse reactions and identifying an effective, safe, economical, and broadly applicable intervention strategy that may facilitate emergence from anesthesia, accelerate postoperative recovery, shorten the length of hospital stay, and reduce hospitalization costs.
This trial aims to determine whether preoperative stellate ganglion block (SGB) and intraoperative intravenous dexmedetomidine (DEX) can improve postoperative sleep quality in patients undergoing laparoscopic gynecologic surgery, and whether the combination of these two interventions provides an interaction effect or additional ben
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stellate Ganglion Block + Dexmedetomidine | Experimental | Drug: DEX 0.2 μg/kg/h., Procedure: SGBStellate ganglion block + dexmedetomidine |
| Stellate Ganglion Block + Placebo | Experimental | Procedure: SGB, Drug: 0.9% Sodium Chloride (Placebo)Stellate ganglion block + 0.9% sodium chloride |
| Sham Stellate Ganglion Block + Dexmedetomidine | Experimental | Drug: DEX 0.2 μg/kg/h., Procedure: Sham Stellate Ganglion BlockSham stellate ganglion block + dexmedetomidine |
| Sham Stellate Ganglion Block + Placebo | Placebo comparator | Drug: 0.9% Sodium Chloride (Placebo), Procedure: Sham Stellate Ganglion BlockSham stellate ganglion block + 0.9% sodium chloride |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with American Society of Anesthesiologists (ASA) physical status I-III;
- Age 18-75 years;
- Scheduled to undergo laparoscopic gynecologic surgery (laparoscopic hysterectomy or laparoscopic surgery for uterine fibroids).
Key exclusion criteria (6 listed)
- Preoperative sore throat or hoarseness;
- History of upper respiratory tract infection within the previous 2 weeks;
- Anticipated difficult tracheal intubation (Mallampati class III or IV, potential facial deformity, mouth opening <3 finger breadths, etc.);
- Severe preoperative cardiac, hepatic, renal, or other organ dysfunction;
- Allergy to the local anesthetic used in the study, infection at the puncture site, or coagulation abnormalities;
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 |
|---|---|---|
| DEX 0.2 μg/kg/h.Dexmedetomidine is administered by intravenous infusion after induction of anesthesia without a loading dose, at an infusion rate of 0.2μg·kg-¹·h-¹, and continued until the end of surgery. | Drug | Sham Stellate Ganglion Block + Dexmedetomidine, Stellate Ganglion Block + Dexmedetomidine |
| SGBStellate ganglion block (SGB) is performed 15 min after induction of anesthesia by an anesthesiologist experienced in ultrasound-guided regional anesthesia, who is aware of the patient's group assignment. The patient is placed in the supine position with the neck slightly extended and rotated to the contralateral side. Under sterile conditions, a high-frequency linear-array ultrasound transducer is used to scan the anterior neck transversely at the C6 level, sequentially identifying the common carotid artery, internal jugular vein, thyroid gland, esophagus, C6 transverse process and anterior tubercle, longus colli muscle, and surrounding vascular structures. In the SGB group, an in-plane needle approach is used under real-time ultrasound guidance. After the needle tip reaches the fascial plane anterior to the longus colli muscle and negative aspiration for blood is confirmed, 5 mL of 0.375% ropivacaine is injected slowly. Spread of the local anesthetic along the surface of the longus | Procedure or surgery | Stellate Ganglion Block + Dexmedetomidine, Stellate Ganglion Block + Placebo |
| 0.9% Sodium Chloride (Placebo)An equal volume of 0.9% sodium chloride solution is administered by intravenous infusion after induction of anesthesia as a placebo for dexmedetomidine and continued until the end of surgery. | Drug | Sham Stellate Ganglion Block + Placebo, Stellate Ganglion Block + Placebo |
| Sham Stellate Ganglion BlockParticipants are placed in the same position as those receiving the stellate ganglion block, and the ultrasound probe is placed on the neck in an identical manner to simulate the procedure. No needle puncture or drug injection is performed. | Procedure or surgery | Sham Stellate Ganglion Block + Dexmedetomidine, Sham Stellate Ganglion Block + Placebo |
Primary outcome
St. Mary's Hospital Sleep Questionnaire Score 1 Day Before Surgery
Time frame: 1 day before surgery（ΡRE）
Subjective sleep quality is assessed using the St. Mary's Hospital Sleep Questionnaire (SMHSQ). The total score ranges from 11 to 37, with higher scores indicating poorer sleep quality.
Total Sleep Time 1 Day Before Surgery
Time frame: 1 day before surgery（PRE）
Total sleep time (TST), expressed in minutes, is objectively measured using a Fitbit Charge 6 wrist-worn device.
Wake After Sleep Onset 1 Day Before Surgery
Time frame: 1 day before surgery（PRE）
Wake after sleep onset is the total duration of wakefulness after initial sleep onset during the assessed sleep period, measured in minutes using a Fitbit Charge 6 wrist-worn device.
Sleep Efficiency 1 Day Before Surgery
Time frame: 1 day before surgery(PRE)
Sleep efficiency is calculated as total sleep time (TST) divided by the sum of total sleep time and wake after sleep onset (WASO), multiplied by 100. TST and WASO are obtained using a Fitbit Charge 6 wrist-worn device. Values range from 0% to 100%, with higher values indicating a greater proportion of the assessed sleep period spent asleep.
St. Mary's Hospital Sleep Questionnaire Score on Postoperative Day 1
Time frame: Postoperative Day 1（POD1）
Subjective sleep quality is assessed using the St. Mary's Hospital Sleep Questionnaire (SMHSQ). The total score ranges from 11 to 37, with higher scores indicating poorer sleep quality.
Total Sleep Time on Postoperative Day 1
Time frame: Postoperative day 1
Total sleep time (TST), expressed in minutes, is objectively measured using a Fitbit Charge 6 wrist-worn device.
Wake After Sleep Onset on Postoperative Day 1
Time frame: Postoperative day 1（ΡOD1)
Wake after sleep onset is the total duration of wakefulness after initial sleep onset during the assessed sleep period, measured in minutes using a Fitbit Charge 6 wrist-worn device.
Sleep Efficiency on Postoperative Day 1
Time frame: Postoperative day 1(ΡOD1)
Sleep efficiency is calculated as total sleep time (TST) divided by the sum of total sleep time and wake after sleep onset (WASO), multiplied by 100. TST and WASO are obtained using a Fitbit Charge 6 wrist-worn device. Values range from 0% to 100%, with higher values indicating a greater proportion of the assessed sleep period spent asleep.
St. Mary's Hospital Sleep Questionnaire Score on Postoperative Day 2
Time frame: Postoperative Day 2（ΡOD2）
Subjective sleep quality is assessed using the St. Mary's Hospital Sleep Questionnaire (SMHSQ). The total score ranges from 11 to 37, with higher scores indicating poorer sleep quality.
Total Sleep Time on Postoperative Day 2
Time frame: Postoperative day 2
Total sleep time (TST), expressed in minutes, is objectively measured using a Fitbit Charge 6 wrist-worn device.
Wake After Sleep Onset on Postoperative Day 2
Time frame: Postoperative day 2(POD2)
Wake after sleep onset is the total duration of wakefulness after initial sleep onset during the assessed sleep period, measured in minutes using a Fitbit Charge 6 wrist-worn device.
Sleep Efficiency on Postoperative Day 2
Time frame: Postoperative day 2(POD2)
Sleep efficiency is calculated as total sleep time (TST) divided by the sum of total sleep time and wake after sleep onset (WASO), multiplied by 100. TST and WASO are obtained using a Fitbit Charge 6 wrist-worn device. Values range from 0% to 100%, with higher values indicating a greater proportion of the assessed sleep period spent asleep.
19 secondary outcomes
Postoperative Pain Intensity at 6 Hours
Time frame: 6 hours after surgery
Postoperative Pain Intensity at 24 Hours
Time frame: 24 hours after surgery
Postoperative Pain Intensity at 48 Hours
Time frame: 48 hours after surgery
Total Intraoperative Sufentanil Consumption
Time frame: From induction of anesthesia to the end of surgery
Total Intraoperative Remifentanil Consumption
Time frame: From induction of anesthesia to the end of surgery
Number of Rescue Analgesia Administrations
Time frame: From the end of surgery to 48 hours after surgery.
Mean Arterial Pressure
Time frame: Before induction of anesthesia (T0), at skin incision (T1), 30 minutes after the start of surgery (T2), 60 minutes after the start of surgery (T3), and at the end of surgery (T4).
Heart Rate
Time frame: Before induction of anesthesia (T0), at skin incision (T1), 30 minutes after the start of surgery (T2), 60 minutes after the start of surgery (T3), and at the end of surgery (T4).
Number of Participants With Local Anesthetic Systemic Toxicity
Time frame: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Puncture-Site Hematoma
Time frame: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Puncture-Site Infection
Time frame: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Unintended Nerve Block
Time frame: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Pneumothorax
Time frame: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Bradycardia
Time frame: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Hypotension
Time frame: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Hypoxemia
Time frame: From administration of the first study intervention to 48 hours after surgery.
Number of Participants With Postoperative Nausea or Vomiting
Time frame: From the end of surgery to 48 hours after surgery.
Number of Participants With Postoperative Headache or Dizziness
Time frame: From the end of surgery to 48 hours after surgery.
Number of Participants With Postoperative Nightmares or Excessive Dreaming
Time frame: From the end of surgery to 48 hours after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 36652140Yang RZ, Li YZ, Liang M, Yu JJ, Chen ML, Qiu JJ, Lin SZ, Wu XD, Zeng K. Stellate Ganglion Block Improves Postoperative Sleep Quality and Analgesia in Patients with Breast Cancer: A Randomized Controlled Trial. Pain Ther. 2023 Apr;12(2):491-503. doi: 10.1007/s40122-022-00473-y. Epub 2023 Jan 18.
- Background: PubMed 30992414Goel V, Patwardhan AM, Ibrahim M, Howe CL, Schultz DM, Shankar H. Complications associated with stellate ganglion nerve block: a systematic review. Reg Anesth Pain Med. 2019 Apr 16:rapm-2018-100127. doi: 10.1136/rapm-2018-100127. Online ahead of print.
- Background: PubMed 18485819Lipov EG, Joshi JR, Sanders S, Wilcox K, Lipov S, Xie H, Maganini R, Slavin K. Effects of stellate-ganglion block on hot flushes and night awakenings in survivors of breast cancer: a pilot study. Lancet Oncol. 2008 Jun;9(6):523-32. doi: 10.1016/S1470-2045(08)70131-1. Epub 2008 May 15.
- Background: PubMed 22893770Kjolhede P, Langstrom P, Nilsson P, Wodlin NB, Nilsson L. The impact of quality of sleep on recovery from fast-track abdominal hysterectomy. J Clin Sleep Med. 2012 Aug 15;8(4):395-402. doi: 10.5664/jcsm.2032.
- Background: PubMed 34506386Manandhar T, Sitaula S, Thapa BD, Agrawal A, Thakur A. Prevalence of Hysterectomy among Gynecological Surgeries in a Tertiary Care Hospital. JNMA J Nepal Med Assoc. 2020 Dec 31;58(232):965-970. doi: 10.31729/jnma.5315.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEX 0.2 μg/kg/h. and SGB in people with Uterine Fibroids (Leiomyoma) and Adenomyosis of Uterus, run by Catherin Zhang at 1 site in China.
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: looking for participants now, 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Wang (+86 19552153837, 1961440528@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
St. Mary's Hospital Sleep Questionnaire Score 1 Day Before Surgery (time frame: 1 day before surgery（ΡRE）). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07860203, which also lists 5 linked publications.
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.