Skip to content

Superior Hypogastric Nerve Block in Minimally-invasive Gynaecology: a Randomised Controlled Trial (Hypoplex Study)

Superior Hypogastric Plexus Nerve Block in Minimally-invasive Gynaecology and it's effect on Post-operative Opiate requirements: a Randomised Controlled Trial (Hypoplex Study)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000242921
Acronym
Hypoplex Study
Enrollment
50
Registered
2020-02-26
Start date
2020-03-02
Completion date
2020-05-11
Last updated
2020-03-03

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

Conditions

None listed

Brief summary

Minimally invasive gynaecology (MIG) requires a high level of pain medication both during the operation and after the operation. This is from the pain elicited during surgical skin incision, gas used in MIG and cutting of tissue and organs. Pain relief after surgery still has a high reliance on opioid medication. In opioid-naïve patients even small doses can lead to poor side effects including nausea and vomiting, slowing of gut transit and difficulty with breathing. A nerve block to the superior hypogastric nerves has been studied previously through observational trials. First in patients with pelvic cancers and more recently for patients after surgery. It is not a difficult nerve block to teach to laparoscopic surgeons. Ropivacaine which is used for the nerve block is a well-studied medication and approved for use by the TGA in Australia. It is also cheap. We plan to study the effect this nerve block as it could be useful adjunct to post-operative pain relief in the future. This is a single-centre, patient-blinded randomised controlled trial. Patients undergoing minimally invasive gynaecological surgery will be randomised to receive a superior hypogastric nerve block with Ropivacaine at the end of their surgery versus no nerve block. The primary outcome to be studied will be total opioid use in the first 24 hours after surgery. Our secondary outcome is pain scores at regular intervals in the first 24 hours. This will be performed using a visual analogue scale from 1 to 10. Our hypothesis is that patients receiving a nerve block will use 30% less opioid over the first 24 hours compared to patients not receiving one. We also predict patients receiving the nerve block will have lower pain scores.

Interventions

10ml of 0.75% Ropivacaine (local anaesthetic) injected retroperitoneally within the presacral space targeting the superior hypogastric plexus. Injection provided at the end of minimally invasive gynaecology surgery using laparoscopic guidance Stratified randomisation with four patient arms Arm 1- Laparoscopic Hysterectomy Arm 2- Laparoscopic Myomectomy Arm 3- Robotic-assisted Laparoscopic Hysterectomy Arm 4- Robotic-assisted Laparoscopic Myomectomy

Sponsors

Praveen De Silva
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age 18 years and over Able to give informed consent Undergoing laparoscopic hysterectomy, laparoscopic myomectomy, robotic-assisted laparoscopic hysterectomy, robotic-assisted laparoscopic myomectomy

Exclusion criteria

Known Malignancy Liver failure or coagulopathy Known hypersensitivity or allergy to local anaesthetic Surgeon/ anaesthetic concerns on ability for patient to use patient-controlled opiate analgesia post-operative Regular opioid use

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026