SUperior Hypogastric Plexus Block During Laparoscopic hysterEctomy (SUBTLE)

ConditionHysterectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to provide informed consent

Undergoing laparoscopic hysterectomy for benign indications

Disqualifiers

Planned procedure that requires dissection of the presacral space

Allergy to block medication (s)

Known or suspected malignancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Superior hypogastric plexus block

    Procedure/Surgery

    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.

Treatment groups

198 Participants
are divided into 2 treatment groups
Group A: Nerve blockExperimental treatment 1 intervention
Group B: Placebo blockPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of recovery

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

Time frame
Postoperative day 1

Secondary outcomes

1

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.

Time frame
Up to postoperative day 2
2

Postoperative Opioid Use

Postoperative opioid consumption during said time points

Time frame
Up to postoperative day 2
3

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.

Time frame
Up to postoperative day 90
4

The McGill Pain Questionnaire

The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain.

Time frame
Up to postoperative day 90

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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