Superior Hypogastric Plexus BlockNCT03428152
Superior Hypogastric Blockade for Postoperative Pain
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 (SHP) block is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Percutaneous 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, Pain, Postoperative
- What is being tested?
- superior hypogastric block
- Type of treatment
- Surgery or procedure
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Feb 2018to 24 Jul 2018
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 hysterectomy under general anesthesia.
Who may be able to join
- ASA I - II
- Elective 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
Derince Training and Research Hospital
Kocaeli, Derince, 41900
About this study
Official title: The Efficacy of Superior Hypogastric Blockade for Postoperative Pain
The primary indication for superior hypogastric (SHP) block is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Percutaneous SHP blocks should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. Because of the close proximity of SHP to major vessels, and structures like vertebral column (for posterior) and guts (for anterior) are being on the way of the needle, these percutaneous blocks are associated with serious complications. Performing SHP during hysterectomy surgery, gives advantages to rule out these complications by exploring the whole intraabdominal anatomy.
The investigators' theory is to find out if SHP blocks (during pelvic surgery) are useful for decreasing VAS pain scores and opioid consumption for postoperative pain.
Read the detailed description
Nerve blocks are frequently used in daily practice as an anesthetic and analgesia technique for surgery, postoperative pain and chronic pain. Total abdominal hysterectomy causes significant postoperative pain. Epidural blocks are frequently preferred for postoperative pain control, since most of the anesthetists are skilled with neuraxial blocks. However, an epidural catheter placement and epidural injections have some side effects and complications.
Pelvis is innervated by thoracolumbar and sacral segments. Autonomic (sympathetic and parasympathetic) and somatic (motor and sensory) nerves provide innervation of pelvis. The sympathetic nervous system, which transmits nociceptive messages from the viscera to brain, plays an important role in the transmission of visceral pain. Generally, in order to block transmission of nociceptive information from the pelvic viscera to the spinal cord, interruption of sympathetic pathways will be necessary. The sympathetic nerve block on the sympathetic nervous system for the management of chronic pelvic pain has been proposed at three main levels: ganglion impar, hypogastric plexus and L2 lumbar sympathetic blocks. By following the pelvic anatomy, there could be an alternative way for acute pain relief for abdominal hysterectomy: superior hypogastric block.
The superior hypogastric plexus lies retroperitoneally in front of L4 as a bunch of fibers. As these fibers descend, at the level of L5 they divide into the hypogastric nerves. The hypogastric nerves pass downward from L5-S1, following the concave curve of the sacrum and passing on each side of the rectum to form the inferior hypogastric plexus. These nerves continue their down¬ward course along each side of the bladder to provide innervation to the pelvic viscera and vasculature.
The primary indication for superior hypogastric block (SHNB) is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Percutaneous SHP blocks can be done by using posterior approach (transdiscal) and paravertebral) and anterior techniques. All of these interventions should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. Because of the close proximity of SHP to major vessels, and structures like vertebral column (for posterior) and guts (for anterior) are being on the way of the needle, these percutaneous blocks are associated with complications.
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. Performing SHP block during hysterectomy surgery, gives advantages to rule out these complications by exploring the whole intraabdominal anatomy. Based on the complexity of the pelvic innervation, SHP blocks do not offer a total painless period like central neuraxial blocks for sure. If SHP block is performed in patients who do not have epidural catheters, it can be useful to decrease postoperative pain scores and opioid or NSAID consumption significantly.
- Being tested
- superior hypogastric block
- Keywords
- superior hypogastric plexus block, hysterectomy, postoperative pain
- Medical subject headings
- Pain, Postoperative, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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: 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 retro-peritoneum 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
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) (PACU: Post-anesthesia care unit) VAS-PACU: VAS scores at PACU VAS 1: VAS scores at postoperative 1st hour (ward) VAS 6: VAS scores at postoperative 6th hour (ward) VAS 12: VAS scores at postoperative 12th hour (ward) VAS 24: VAS scores at postoperative 24th hour (ward) VAS 48: VAS scores at postoperative 48th hour (ward)
Measured: postoperative 48 hour follow-up (PACU and ward)
Postoperative Analgesic Consumption
Total number of non-steroid anti-inflammatory drug (NSAID) and opioid vials that are applied to patients in post-anesthesia care unit (PACU) and at ward will be recorded.
Target VAS score for NSAID is >4; if there is no response to NSAID and pain is worsening opioid drugs will be applied (this is our routine clinical practice) NSAID: Diclofenac sodium 75mg per vial; opioid: Tramadol 100mg per vial.
Measured: postoperative 48 hour follow-up (PACU and ward)
Secondary outcomes (4)
Rescue Analgesic Time
Time to first analgesic demand at gynecology ward (after transfer from PACU to gynecology ward)
Measured: 48 hours (time to the first analgesic demand will be recorded)
Duration of Operation
the time from the the first incision to the skin to skin closure.
Measured: from the induction of anesthesia and the end of the surgery
Length of Hospital Stay
length of hospital stay time will be recorded
Measured: assessed up to 1 week
Number of Participants With Complications Due to SHP Block
intra/postoperative complications will be noted. (post-operative nausea and vomiting (PONV) or others: ie: intra-vascular local anesthetic injection, vascular puncture, hemodynamical changes after injection,.. )
Measured: From the SHP block time (intraoperative) until discharge
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 start9 Feb 2018
- Primary completion23 Jul 2018
- Study completion24 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)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
- 78 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande Gurbuz, Derince Training and Research Hospital
- Investigators
- Hande G. Aytuluk, MD, Principal investigator, Derince Training and Research HospitalGulfem Basol, MD, Study chair, Derince Training and Research HospitalAhmet Kale, Prof, Study chair, Derince Training and Research HospitalCanan Balci, Assoc Prof, Study chair, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428152
- Sponsor's protocol ID
- U1111-1205-2226
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2018
- Last updated
- 13 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: The investigators do not prefer to share the study plan and records.
Publications
Plancarte R, de Leon-Casasola OA, El-Helaly M, Allende S, Lema MJ. Neurolytic superior hypogastric plexus block for chronic pelvic pain associated with cancer. Reg Anesth. 1997 Nov-Dec;22(6):562-8.
PubMed 9425974de Leon-Casasola OA, Kent E, Lema MJ. Neurolytic superior hypogastric plexus block for chronic pelvic pain associated with cancer. Pain. 1993 Aug;54(2):145-151. doi: 10.1016/0304-3959(93)90202-Z.
PubMed 8233527Sindt 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 27208713Choi JW, Kim WH, Lee CJ, Sim WS, Park S, Chae HB. The Optimal Approach for a Superior Hypogastric Plexus Block. Pain Pract. 2018 Mar;18(3):314-321. doi: 10.1111/papr.12603. Epub 2017 Jul 6.
PubMed 28520297Turker G, Basagan-Mogol E, Gurbet A, Ozturk C, Uckunkaya N, Sahin S. A new technique for superior hypogastric plexus block: the posteromedian transdiscal approach. Tohoku J Exp Med. 2005 Jul;206(3):277-81. doi: 10.1620/tjem.206.277.
PubMed 15942158Erdine 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 12945023Rapp H, Ledin Eriksson S, Smith P. Superior hypogastric plexus block as a new method of pain relief after abdominal hysterectomy: double-blind, randomised clinical trial of efficacy. BJOG. 2017 Jan;124(2):270-276. doi: 10.1111/1471-0528.14119. Epub 2016 Jun 12.
PubMed 27292167Aytuluk HG, Kale A, Astepe BS, Basol G, Balci C, Colak T. Superior Hypogastric Plexus Blocks for Postoperative Pain Management in Abdominal Hysterectomies. Clin J Pain. 2020 Jan;36(1):41-46. doi: 10.1097/AJP.0000000000000767.
PubMed 31567396
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Superior Hypogastric Blockade for Postoperative Pain
- ClinicalTrials.gov ID
- NCT03428152
- Acronym / sponsor ID
- U1111-1205-2226
- Keywords
- superior hypogastric plexus block, hysterectomy, postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 24 Jul 2018 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Posted 3 Jun 2019
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 (SHP) block is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Percutaneous SHP blocks should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. Because of the close proximity of SHP to major vessels, and structures like vertebral column (for posterior) and guts (for anterior) are being on the way of the needle, these percutaneous blocks are associated with serious complications. Performing SHP during hysterectomy surgery, gives advantages to rule out these complications by exploring the whole intraabdominal anatomy.
The investigators' theory is to find out if SHP blocks (during pelvic surgery) are useful for decreasing VAS pain scores and opioid consumption for postoperative pain.
Detailed description
Nerve blocks are frequently used in daily practice as an anesthetic and analgesia technique for surgery, postoperative pain and chronic pain. Total abdominal hysterectomy causes significant postoperative pain. Epidural blocks are frequently preferred for postoperative pain control, since most of the anesthetists are skilled with neuraxial blocks. However, an epidural catheter placement and epidural injections have some side effects and complications.
Pelvis is innervated by thoracolumbar and sacral segments. Autonomic (sympathetic and parasympathetic) and somatic (motor and sensory) nerves provide innervation of pelvis. The sympathetic nervous system, which transmits nociceptive messages from the viscera to brain, plays an important role in the transmission of visceral pain. Generally, in order to block transmission of nociceptive information from the pelvic viscera to the spinal cord, interruption of sympathetic pathways will be necessary. The sympathetic nerve block on the sympathetic nervous system for the management of chronic pelvic pain has been proposed at three main levels: ganglion impar, hypogastric plexus and L2 lumbar sympathetic blocks. By following the pelvic anatomy, there could be an alternative way for acute pain relief for abdominal hysterectomy: superior hypogastric block.
The superior hypogastric plexus lies retroperitoneally in front of L4 as a bunch of fibers. As these fibers descend, at the level of L5 they divide into the hypogastric nerves. The hypogastric nerves pass downward from L5-S1, following the concave curve of the sacrum and passing on each side of the rectum to form the inferior hypogastric plexus. These nerves continue their down¬ward course along each side of the bladder to provide innervation to the pelvic viscera and vasculature.
The primary indication for superior hypogastric block (SHNB) is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Percutaneous SHP blocks can be done by using posterior approach (transdiscal) and paravertebral) and anterior techniques. All of these interventions should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. Because of the close proximity of SHP to major vessels, and structures like vertebral column (for posterior) and guts (for anterior) are being on the way of the needle, these percutaneous blocks are associated with complications.
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. Performing SHP block during hysterectomy surgery, gives advantages to rule out these complications by exploring the whole intraabdominal anatomy. Based on the complexity of the pelvic innervation, SHP blocks do not offer a total painless period like central neuraxial blocks for sure. If SHP block is performed in patients who do not have epidural catheters, it can be useful to decrease postoperative pain scores and opioid or NSAID consumption significantly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypo | – | Procedure: 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 retro-peritoneum 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 hysterectomy under general anesthesia.
Key inclusion criteria (2 listed)
- ASA I - II
- Elective 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 |
|---|---|---|
| superior hypogastric blocksuperior hypogastric blockade during surgery | Procedure or surgery | Hypo |
Primary outcome
Postoperative Pain Scores
Time frame: postoperative 48 hour follow-up (PACU and 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) (PACU: Post-anesthesia care unit) VAS-PACU: VAS scores at PACU VAS 1: VAS scores at postoperative 1st hour (ward) VAS 6: VAS scores at postoperative 6th hour (ward) VAS 12: VAS scores at postoperative 12th hour (ward) VAS 24: VAS scores at postoperative 24th hour (ward) VAS 48: VAS scores at postoperative 48th hour (ward)
Postoperative Analgesic Consumption
Time frame: postoperative 48 hour follow-up (PACU and ward)
Total number of non-steroid anti-inflammatory drug (NSAID) and opioid vials that are applied to patients in post-anesthesia care unit (PACU) and at ward will be recorded. Target VAS score for NSAID is >4; if there is no response to NSAID and pain is worsening opioid drugs will be applied (this is our routine clinical practice) NSAID: Diclofenac sodium 75mg per vial; opioid: Tramadol 100mg per vial.
4 secondary outcomes
Rescue Analgesic Time
Time frame: 48 hours (time to the first analgesic demand will be recorded)
Duration of Operation
Time frame: from the induction of anesthesia and the end of the surgery
Length of Hospital Stay
Time frame: assessed up to 1 week
Number of Participants With Complications Due to SHP Block
Time frame: From the SHP block time (intraoperative) until discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9425974Plancarte R, de Leon-Casasola OA, El-Helaly M, Allende S, Lema MJ. Neurolytic superior hypogastric plexus block for chronic pelvic pain associated with cancer. Reg Anesth. 1997 Nov-Dec;22(6):562-8.
- Background: PubMed 8233527de Leon-Casasola OA, Kent E, Lema MJ. Neurolytic superior hypogastric plexus block for chronic pelvic pain associated with cancer. Pain. 1993 Aug;54(2):145-151. doi: 10.1016/0304-3959(93)90202-Z.
- Background: 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.
- Background: PubMed 28520297Choi JW, Kim WH, Lee CJ, Sim WS, Park S, Chae HB. The Optimal Approach for a Superior Hypogastric Plexus Block. Pain Pract. 2018 Mar;18(3):314-321. doi: 10.1111/papr.12603. Epub 2017 Jul 6.
- Background: PubMed 15942158Turker G, Basagan-Mogol E, Gurbet A, Ozturk C, Uckunkaya N, Sahin S. A new technique for superior hypogastric plexus block: the posteromedian transdiscal approach. Tohoku J Exp Med. 2005 Jul;206(3):277-81. doi: 10.1620/tjem.206.277.
- Background: 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.
- Results publication: PubMed 27292167Rapp H, Ledin Eriksson S, Smith P. Superior hypogastric plexus block as a new method of pain relief after abdominal hysterectomy: double-blind, randomised clinical trial of efficacy. BJOG. 2017 Jan;124(2):270-276. doi: 10.1111/1471-0528.14119. Epub 2016 Jun 12.
- Derived from this study: PubMed 31567396Aytuluk HG, Kale A, Astepe BS, Basol G, Balci C, Colak T. Superior Hypogastric Plexus Blocks for Postoperative Pain Management in Abdominal Hysterectomies. Clin J Pain. 2020 Jan;36(1):41-46. doi: 10.1097/AJP.0000000000000767.
- Individual participant dataSharing planned: No. The investigators do not prefer to share the study plan and records.
Related trials for Superior Hypogastric Plexus Block
Recruiting
Combination of Superior Hypogastric Plexus Block and Transversus Abdominis Plane Block in Abdominal Hysterectomies
Superior Hypogastric Plexus Block, Transversus Abdominis Plane Block
Recruiting
Superior HypogastrIc plExus bLock During Laparoscopic Colorectal Cancer Surgery
Colorectal Cancer (Diagnosis), Laparoscopic Surgery
RecruitingPhase 2
Presacral Nerve Block Versus Sham Block on Post-operative Pain for Total Laparoscopic Hysterectomy
Post-operative Pain
Recruiting
Peripheral Autonomic Block (BAP) Plus Transversus Abdominis Plane Block (TAP) for Postoperative Analgesia After Minimally Invasive Left-Sided Colorectal Resection (BAPTAP)
Colorectal Cancer, Colorectal Surgery
Recruiting
Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management
Cervical Cancer, Endometrial Cancer
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 G. Aytuluk, MD principal investigator
Derince Training and Research Hospital
Gulfem Basol, MD study chair
Derince Training and Research Hospital
Ahmet Kale, Prof 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: finished, as of the sponsor's last update on 13 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Scores (time frame: postoperative 48 hour follow-up (PACU and ward)). The study lists 2 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 NCT03428152, which also lists 8 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 13 Mar 2024.