HysterectomySUBTLENCT06455540
SUperior Hypogastric Plexus Block During Laparoscopic hysterEctomy (SUBTLE)
A study testing Superior hypogastric plexus block in people with Hysterectomy, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
This trial sest to assess the efficacy of a superior hypogastric plexus block (SHPB) for quality of recovery after a laparoscopic hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Superior hypogastric plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- 16 Jul 2024to 31 Dec 2025
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- Undergoing laparoscopic hysterectomy for benign indications
Who cannot join
- Planned procedure that requires dissection of the presacral space
- Allergy to block medication (s)
- Known or suspected malignancy
About this study
Official title: Superior Hypogastric Plexus Block During Laparoscopic Hysterectomy
This trial sest to assess the efficacy of a superior hypogastric plexus block (SHPB) for quality of recovery after a laparoscopic hysterectomy.
- Conditions
- Hysterectomy
- Being tested
- Superior hypogastric plexus block
- Keywords
- Hysterectomy, Minimally invasive surgery, Quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superior hypogastric plexus blockProcedure or surgery
Also called Nerve block
Prior to the laparoscopic hysterectomy and any additional procedures, the superior hypogastric plexus block will be performed on all the patients. The block will contain 20 mL of 0.75% ropivacaine hydrochloride or 0.9% normal saline. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.
| Study group | Role | What they receive |
|---|---|---|
| Nerve block | Experimental | The superior hypogastric plexus block in this group will contain 20 mL of 0.75% ropivacaine hydrochloride. Receives: Procedure: Superior hypogastric plexus block |
| Placebo block | Placebo comparator | The superior hypogastric plexus block in this group will contain 20 mL of 0.9% normal saline. Receives: Procedure: Superior hypogastric plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery
The Quality of recovery (QoR) 15 is a patient-reported outcome questionnaire that measures the quality of recovery after surgery.
Measured: Postoperative day 1
Secondary outcomes (8)
Postoperative Pain Scores
Pain reported according to a visual rating scale from 0 to 100 points (0= no pain and 100= worst imaginable pain), which details their pain level using Visual Analog Scale (VAS) pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 100, and a higher score indicates greater pain intensity.
Measured: Up to postoperative day 2
Postoperative Opioid Use
Postoperative opioid consumption during said time points
Measured: Up to postoperative day 2
The Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) is a self-administered questionnaire to assess the severity of pain and the impact of pain on the patient's daily functions.
Measured: Up to postoperative day 90
The McGill Pain Questionnaire
The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain.
Measured: Up to postoperative day 90
Incidence of Adverse events
Incidence of adverse events related to the plexus block (vascular puncture, hematoma, and local anesthetic systemic toxicity (LAST))
Measured: Intraoperative (During block performance)
Length of stay in post-anesthesia care unit (PACU) area
Total time in PACU area
Measured: Postoperative day 1
Quality of recovery
The Quality of recovery (QoR) 15 is a patient-reported outcome questionnaire that measures the quality of recovery after surgery.
Measured: Up to postoperative day 2
Postoperative nausea and vomiting
number of participants with nausea or vomiting
Measured: Up to postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start16 Jul 2024 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455540
- Sponsor's protocol ID
- E2022273
- Acronym
- SUBTLE
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Hypogastric Plexus Block During Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT06455540
- Acronym / sponsor ID
- SUBTLE / E2022273
- Conditions
- Hysterectomy
- Keywords
- Hysterectomy, Minimally invasive surgery, Quality of recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 16 Jul 2024 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Jun 2024 (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.
This trial sest to assess the efficacy of a superior hypogastric plexus block (SHPB) for quality of recovery after a laparoscopic hysterectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve block | Experimental | Procedure: Superior hypogastric plexus blockThe superior hypogastric plexus block in this group will contain 20 mL of 0.75% ropivacaine hydrochloride. |
| Placebo block | Placebo comparator | Procedure: Superior hypogastric plexus blockThe superior hypogastric plexus block in this group will contain 20 mL of 0.9% normal saline. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to provide informed consent
- Undergoing laparoscopic hysterectomy for benign indications
Key exclusion criteria (3 listed)
- Planned procedure that requires dissection of the presacral space
- Allergy to block medication (s)
- Known or suspected malignancy
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 |
|---|---|---|
| Superior hypogastric plexus blockAlso: Nerve blockPrior to the laparoscopic hysterectomy and any additional procedures, the superior hypogastric plexus block will be performed on all the patients. The block will contain 20 mL of 0.75% ropivacaine hydrochloride or 0.9% normal saline. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block. | Procedure or surgery | Nerve block, Placebo block |
Primary outcome
Quality of recovery
Time frame: Postoperative day 1
The Quality of recovery (QoR) 15 is a patient-reported outcome questionnaire that measures the quality of recovery after surgery.
8 secondary outcomes
Postoperative Pain Scores
Time frame: Up to postoperative day 2
Postoperative Opioid Use
Time frame: Up to postoperative day 2
The Brief Pain Inventory (BPI)
Time frame: Up to postoperative day 90
The McGill Pain Questionnaire
Time frame: Up to postoperative day 90
Incidence of Adverse events
Time frame: Intraoperative (During block performance)
Length of stay in post-anesthesia care unit (PACU) area
Time frame: Postoperative day 1
Quality of recovery
Time frame: Up to postoperative day 2
Postoperative nausea and vomiting
Time frame: Up to postoperative day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Superior hypogastric plexus block in people with Hysterectomy, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Quality of recovery (time frame: Postoperative day 1). 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 14 Jun 2024.