ClinicalTrials.gg
Status unknownNCT03427840Updated Mar 20, 2018

Superior Hypogastric Plexus Blockade in Laparoscopic Hysterectomy

An observational study in Superior Hypogastric Plexus Block, Hysterectomy and Minimally Invasive Surgery, sponsored by Derince Training and Research Hospital. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-20.

Sponsored by Derince Training and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 65 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,095 studies in Pain, Postoperative with a site in Turkey — 264 open to participants now, 296 under way, none of them phase 3. Pain, Postoperative · Turkey.

Planned enrollment
148th of 215
60 · median 80
Started
2018
with 49 others
Observational
215 of 1,095
45 open now
Registered
66th of 1,095
by date

Among the 1,095 studies in Pain, Postoperative with a site in Turkey, this one is the 148th largest by planned enrollment of the 215 observational ones that give a count, is one of 50 that started in 2018, is one of 215 observational ones, and was the 66th registered.

Pain, Postoperative

5,648 studies on the registry are indexed under Pain, Postoperative; 1,231 are open to participants now.

Browse Pain, Postoperative studies →

Open to participants now

264 of the 1,095 studies in Pain, Postoperative with a site in Turkey are open now. Recruiting first, the newest first:

259 more — sign in →

All 264 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 679 Pain, Postoperative studies recruiting now, 240 (35%) set no upper age limit and 329 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.

This study: 18 Years to 65 Years · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,095 studies in Pain, Postoperative with a site in Turkey, or all of them as a file.
02

Study summary

The primary indication for superior hypogastric plexus (SHP) block is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Per-cutaneous SHP blocks should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. During minimally invasive laparoscopic surgery, percutaneous technique can be done under the guidance of cameras.

Read the detailed description

Laparoscopic surgeries have many advantages over open surgeries. Laparoscopic procedures are mostly preferred for surgical treatment of gynecologic diseases, because of best cosmetically results, less perioperative complications, early recovery, and less postoperative pain.

There are many undesirable effects of systemic reactions to the pain. Accordingly, multi-modal analgesic approach (including nerve blocks) for postoperative acute pain can decrease the side effects of the drugs (especially opioids) significantly.

The primary indication for superior hypogastric plexus (SHP) block is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Per-cutaneous SHP blocks should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. During minimally invasive laparoscopic surgery, per-cutaneous technique can be done under the guidance of cameras.

SHP block has been performed by anesthetists or surgeons in Kocaeli Derince Training and Research Hospital regularly since they have discovered the advantages of this block technique. SHP can be useful to decrease postoperative pain scores and opioid or NSAID consumption significantly.

03

Conditions studied

  • Superior Hypogastric Plexus Block
  • Hysterectomy
  • Minimally Invasive Surgery
  • Laparoscopy
  • Pain, Postoperative
  • Gynecologic Disease

Keywords

  • Superior Hypogastric Plexus Block
  • Hysterectomy
  • Minimally invasive surgery
  • Laparoscopy
  • Pain
  • Gynecologic Disease
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The patients who are scheduled for elective laparoscopic hysterectomy under general anesthesia.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Elective laparoscopic hysterectomy

Exclusion criteria

Exclusion Criteria:

  • Different kind of surgery
  • Known allergy to local anesthetic drugs
  • Different analgesia protocol (ie: epidural, TAP block,..)
  • Refusal of the patient
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Hypo

    The participants with a superior hypogastric block

    Procedure: Procedure/Surgery: superior hypogastric block

  • NoHypo

    The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retroperitone is opened intraoperatively by the surgeon)

Interventions

  • ProcedureProcedure/Surgery: superior hypogastric block

    superior hypogastric blockade during surgery

06

What researchers measure

Primary outcomes

  1. postoperative pain scores (PACU)

    Patients' pain scores will be scored with a 10 cm Visual Analogue Scale (VAS). Each will be scored between 0-10 (0: no pain; 10: worst pain ever)

    Time frame: 1 hour (postoperatively)

  2. postoperative opioid/NSAID consumption (PACU)

    nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted down.

    Time frame: 1 hour (postoperatively)

  3. rescue analgesic time

    Time to first analgesic demand at gynecology ward (after transfer from PACU to gynecology ward)

    Time frame: 48 hours (first analgesic demand time will be noted down)

  4. postoperative pain scores (ward)

    Patients' pain scores will be scored with a 10 cm Visual Analogue Scale (VAS). Each will be scored between 0-10 (0: no pain; 10: worst pain ever)

    Time frame: 48 hours (postoperatively)

  5. postoperative opioid/NSAID consumption (ward)

    NSAID or opioid drugs that are applied to patients will be noted down. Target VAS score for NSAID is \>4; if there is no response to NSAID and pain is worsening opioid drugs will be applied

    Time frame: 48 hours (total)

Secondary outcomes

  1. Intraoperative hemodynamics

    (If the patient is received a SHP block intraoperatively) post-block hemodynamical parametres will be noted down

    Time frame: from SHP block to the end of the surgery (approximately 15 min)

  2. length of stay

    length of hospital stay time will be noted

    Time frame: 3-5 days (expected)

  3. complications due to SHP block

    intra/postoperative complications will be noted. (ie: intra-vascular local anesthetic injection, vascular puncture, hemodynamical changes after injection,.. )

    Time frame: 3-5 days (from surgery to discharge from the hospital)

07

Study locations

1 of 1 sites recruiting
  • Derince Training and Research Hospital
    Kocaeli, Derince 41900, Turkey
    Recruiting
    • Hande G. Aytuluk, MD · Contacthandegrbz@gmail.com · +90 533 651 56 50
    • Gulfem Basol, MD · Contactglfem412010@hotmail.com · +90 530 140 23 20
    • Hande G. Aytuluk, MD · Principal investigator
    • Gulfem Basol, MD · Sub investigator
    • Ahmet Kale, Prof · Sub investigator
08

References and documents

Publications

  • Song T, Kim MK, Jung YW, Yun BS, Seong SJ, Choi CH, Kim TJ, Lee JW, Bae DS, Kim BG. Minimally invasive compared with open surgery in patients with borderline ovarian tumors. Gynecol Oncol. 2017 Jun;145(3):508-512. doi: 10.1016/j.ygyno.2017.03.019. Epub 2017 Apr 2. PubMed 28381342 ↗
  • Lovich-Sapola J, Smith CE, Brandt CP. Postoperative pain control. Surg Clin North Am. 2015 Apr;95(2):301-18. doi: 10.1016/j.suc.2014.10.002. Epub 2015 Jan 24. PubMed 25814108 ↗
  • Sindt JE, Brogan SE. Interventional Treatments of Cancer Pain. Anesthesiol Clin. 2016 Jun;34(2):317-39. doi: 10.1016/j.anclin.2016.01.004. PubMed 27208713 ↗
  • Erdine S, Yucel A, Celik M, Talu GK. Transdiscal approach for hypogastric plexus block. Reg Anesth Pain Med. 2003 Jul-Aug;28(4):304-8. doi: 10.1016/s1098-7339(03)00191-3. PubMed 12945023 ↗
  • Aytuluk HG, Kale A, Basol G. Laparoscopic Superior Hypogastric Blocks for Postoperative Pain Management in Hysterectomies: A New Technique for Superior Hypogastric Blocks. J Minim Invasive Gynecol. 2019 May-Jun;26(4):740-747. doi: 10.1016/j.jmig.2018.08.008. Epub 2018 Aug 28. PubMed 30165185 ↗

Individual participant data

Plan to share: No — The investigators do not prefer to share the study plan and records.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2018 (actual). Primary completion is estimated for Jun 2018, 3 months after the start.

Of 391 non-industry observational studies under Pain, Postoperative, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 3 months is below that.

Counting every sponsor, half of 395 studies reached it within 13 months; a quarter within 5 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2018
First posted
Feb 9, 2018
StartActual
Mar 18, 2018
Primary completionEst.
Jun 30, 2018
CompletionEst.
Jul 1, 2018
Last update
Mar 20, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03427840
Lead sponsor
Derince Training and Research Hospital
Responsible party
Hande G. Aytuluk (M.D., Principal investigator, Derince Training and Research Hospital) — Principal investigator
First posted
Feb 9, 2018
Start date
Mar 18, 2018
Primary completion
Jun 30, 2018 (estimated)
Completion
Jul 1, 2018 (estimated)
Last update
Mar 20, 2018

Study contacts

Hande Aytuluk, MD
Contact
handegrbz@gmail.com
+902623198000
Hande Aytuluk, MD
principal investigator · Derince Training and Research Hospital
Ahmet Kale, Prof
study chair · Derince Training and Research Hospital
Gulfem Basol, MD
study chair · Derince Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion