Superior Hypogastric Plexus BlockNCT03427840
Superior Hypogastric Plexus Blockade in Laparoscopic Hysterectomy
An observational study of Superior Hypogastric Plexus Block and Hysterectomy, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Superior Hypogastric Plexus Block, Hysterectomy, Minimally Invasive Surgery
- What is being tested?
- Procedure/Surgery: superior hypogastric block
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Mar 2018to 1 Jul 2018
- Phase
- Observational
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The patients who are scheduled for elective laparoscopic hysterectomy under general anesthesia.
Who may be able to join
- ASA I - II
- Elective laparoscopic hysterectomy
Who cannot join
- ASA III
- Different kind of surgery
- Known allergy to local anesthetic drugs
- Different analgesia protocol (ie: epidural, TAP block,..)
- Refusal of the patient
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Derince Training and Research Hospital
Kocaeli, Derince, 41900
Hande G. Aytuluk, MD, +90 533 651 56 50, handegrbz@gmail.com
Gulfem Basol, MD, +90 530 140 23 20, glfem412010@hotmail.com
About this study
Official title: Efficacy of Intraoperative Superior Hypogastric Plexus Blockade for Postoperative Pain in Laparoscopic Hysterectomy
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.
- Conditions
- Superior Hypogastric Plexus Block, Hysterectomy, Minimally Invasive Surgery, Laparoscopy, Pain, Postoperative, Gynecologic Disease
- Being tested
- Procedure/Surgery: superior hypogastric block
- Keywords
- Superior Hypogastric Plexus Block, Hysterectomy, Minimally invasive surgery, Laparoscopy, Pain, Gynecologic Disease
- Medical subject headings
- Pain, Postoperative, Genital Diseases, Female, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/Surgery: superior hypogastric blockProcedure or surgery
superior hypogastric blockade during surgery
| Study group | Role | What they receive |
|---|---|---|
| Hypo | The participants with a superior hypogastric block Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 hour (postoperatively)
postoperative opioid/NSAID consumption (PACU)
nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted down.
Measured: 1 hour (postoperatively)
rescue analgesic time
Time to first analgesic demand at gynecology ward (after transfer from PACU to gynecology ward)
Measured: 48 hours (first analgesic demand time will be noted down)
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)
Measured: 48 hours (postoperatively)
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
Measured: 48 hours (total)
Secondary outcomes (3)
Intraoperative hemodynamics
(If the patient is received a SHP block intraoperatively) post-block hemodynamical parametres will be noted down
Measured: from SHP block to the end of the surgery (approximately 15 min)
length of stay
length of hospital stay time will be noted
Measured: 3-5 days (expected)
complications due to SHP block
intra/postoperative complications will be noted. (ie: intra-vascular local anesthetic injection, vascular puncture, hemodynamical changes after injection,.. )
Measured: 3-5 days (from surgery to discharge from the hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start18 Mar 2018
- Primary completion30 Jun 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Superior Hypogastric Plexus BlockStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande G. Aytuluk, Derince Training and Research Hospital
- Investigators
- Hande Aytuluk, MD, Principal investigator, Derince Training and Research HospitalAhmet Kale, Prof, Study chair, Derince Training and Research HospitalGulfem Basol, MD, Study chair, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427840
- Sponsor's protocol ID
- U1111-1208-8608
- Status last verified
- Mar 2018
- First submitted
- 1 Feb 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not prefer to share the study plan and records.
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 28381342Lovich-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 25814108Sindt 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 27208713Erdine 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 12945023Aytuluk 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intraoperative Superior Hypogastric Plexus Blockade for Postoperative Pain in Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT03427840
- Acronym / sponsor ID
- U1111-1208-8608
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 18 Mar 2018 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 9 Feb 2018 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypo | – | Procedure: Procedure/Surgery: superior hypogastric blockThe participants with a 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who are scheduled for elective laparoscopic hysterectomy under general anesthesia.
Key inclusion criteria (2 listed)
- ASA I - II
- Elective laparoscopic hysterectomy
Key exclusion criteria (5 listed)
- ASA III
- Different kind of surgery
- Known allergy to local anesthetic drugs
- Different analgesia protocol (ie: epidural, TAP block,..)
- Refusal of the patient
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 |
|---|---|---|
| Procedure/Surgery: superior hypogastric blocksuperior hypogastric blockade during surgery | Procedure or surgery | Hypo |
Primary outcome
postoperative pain scores (PACU)
Time frame: 1 hour (postoperatively)
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)
postoperative opioid/NSAID consumption (PACU)
Time frame: 1 hour (postoperatively)
nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted down.
rescue analgesic time
Time frame: 48 hours (first analgesic demand time will be noted down)
Time to first analgesic demand at gynecology ward (after transfer from PACU to gynecology ward)
postoperative pain scores (ward)
Time frame: 48 hours (postoperatively)
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)
postoperative opioid/NSAID consumption (ward)
Time frame: 48 hours (total)
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
3 secondary outcomes
Intraoperative hemodynamics
Time frame: from SHP block to the end of the surgery (approximately 15 min)
length of stay
Time frame: 3-5 days (expected)
complications due to SHP block
Time frame: 3-5 days (from surgery to discharge from the hospital)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Results publication: PubMed 28381342Song 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.
- Results publication: PubMed 25814108Lovich-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.
- Results publication: PubMed 27208713Sindt JE, Brogan SE. Interventional Treatments of Cancer Pain. Anesthesiol Clin. 2016 Jun;34(2):317-39. doi: 10.1016/j.anclin.2016.01.004.
- Results publication: PubMed 12945023Erdine 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.
- Derived from this study: PubMed 30165185Aytuluk 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.
- Individual participant dataSharing planned: No. The investigators do not prefer to share the study plan and records.
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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.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superior Hypogastric Plexus Block and Hysterectomy, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Hande Aytuluk, MD (+902623198000, handegrbz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain scores (PACU) (time frame: 1 hour (postoperatively)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03427840, which also lists 5 linked publications.
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 20 Mar 2018; AzTrials last refreshed its copy on 3 Nov 2026.