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SUperior Hypogastric Plexus Block During Laparoscopic hysterEctomy (SUBTLE)

Superior Hypogastric Plexus Block During Laparoscopic Hysterectomy

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06455540
Acronym
SUBTLE
Enrollment
198
Registered
2024-06-12
Start date
2024-07-16
Completion date
2025-12-31
Last updated
2024-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy

Keywords

Hysterectomy, Minimally invasive surgery, Quality of recovery

Brief summary

This trial sest to assess the efficacy of a superior hypogastric plexus block (SHPB) for quality of recovery after a laparoscopic hysterectomy.

Interventions

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.

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Able to provide informed consent * Undergoing laparoscopic hysterectomy for benign indications

Exclusion criteria

* Planned procedure that requires dissection of the presacral space * Allergy to block medication (s) * Known or suspected malignancy

Design outcomes

Primary

MeasureTime frameDescription
Quality of recoveryPostoperative day 1The Quality of recovery (QoR) 15 is a patient-reported outcome questionnaire that measures the quality of recovery after surgery.

Secondary

MeasureTime frameDescription
Postoperative Opioid UseUp to postoperative day 2Postoperative opioid consumption during said time points
The Brief Pain Inventory (BPI)Up to postoperative day 90The 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.
The McGill Pain QuestionnaireUp to postoperative day 90The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain.
Postoperative Pain ScoresUp to postoperative day 2Pain 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.
Length of stay in post-anesthesia care unit (PACU) areaPostoperative day 1Total time in PACU area
Quality of recoveryUp to postoperative day 2The Quality of recovery (QoR) 15 is a patient-reported outcome questionnaire that measures the quality of recovery after surgery.
Postoperative nausea and vomitingUp to postoperative day 2number of participants with nausea or vomiting
Incidence of Adverse eventsIntraoperative (During block performance)Incidence of adverse events related to the plexus block (vascular puncture, hematoma, and local anesthetic systemic toxicity (LAST))

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026