An observational study in Superior Hypogastric Plexus Block, Hysterectomy and Pain, Postoperative, sponsored by Derince Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Derince Training and Research Hospital · Observational
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 78 is below the median of 102 across 683 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Derince Training and Research Hospital is the lead sponsor of 39 studies on the registry; none are open to participants now.
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The patients who are scheduled for elective 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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participants with a superior hypogastric block
Procedure: superior hypogastric block
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)
superior hypogastric blockade during surgery
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)
Time frame: 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.
Time frame: postoperative 48 hour follow-up (PACU and ward)
Rescue Analgesic Time
Time to first analgesic demand at gynecology ward (after transfer from PACU to gynecology ward)
Time frame: 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.
Time frame: from the induction of anesthesia and the end of the surgery
Length of Hospital Stay
length of hospital stay time will be recorded
Time frame: 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,.. )
Time frame: From the SHP block time (intraoperative) until discharge
| Milestone | Hypo | NoHypo |
|---|---|---|
| Started | 37 | 41 |
| Completed | 30 | 30 |
| Not completed | 7 | 11 |
| Withdrew: Physician decision | 4 | 2 |
| Withdrew: Protocol violation | 3 | 5 |
| Withdrew: Lack of efficacy | 0 | 4 |
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)
| units on a scale | Hypo | NoHypo |
|---|---|---|
| VAS PACU | 4.76 ± 1.55 | 7.38 ± 1.63 |
| VAS 1 | 3.7 ± 3.36 | 6.66 ± 2.10 |
| VAS 6 | 1.9 ± 1.32 | 4.23 ± 2.03 |
| VAS 12 | 0.83 ± 0.74 | 3.16 ± 2.13 |
| VAS 24 | 0.53 ± 0.68 | 2.1 ± 2.17 |
| VAS 48 | 0.2 ± 0.4 | 1.2 ± 1.39 |
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.
| vials | Hypo | NoHypo |
|---|---|---|
| NSAID PACU | 0.8 ± 0.4 | 0.96 ± 0.18 |
| Opioid PACU | 0.1 ± 0.3 | 0.36 ± 0.49 |
| NSAID ward | 2.83 ± 1.23 | 5.77 ± 1.24 |
| Opioid ward | 0 ± 0 | 0.63 ± 0.71 |
Time to first analgesic demand at gynecology ward (after transfer from PACU to gynecology ward)
| minutes | Hypo | NoHypo |
|---|---|---|
| Rescue Analgesic Time | 627 ± 352.89 | 203.83 ± 173.13 |
the time from the the first incision to the skin to skin closure.
| minutes | Hypo | NoHypo |
|---|---|---|
| Duration of Operation | 115.83 ± 34.19 | 114.16 ± 34.59 |
length of hospital stay time will be recorded
| days | Hypo | NoHypo |
|---|---|---|
| Length of Hospital Stay | 2.66 ± 0.6 | 2.96 ± 1.32 |
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,.. )
| Participants | Hypo | NoHypo |
|---|---|---|
| PONV | 7 | 8 |
| others | 0 | 0 |
Collected over From the SHP block time (intraoperative) until discharge. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hypo | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| NoHypo | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Age, Continuous(years) | Hypo | NoHypo | Total |
|---|---|---|---|
| Mean | 52.36 ± 6.51 | 51.63 ± 7.49 | 52 ± 6.96 |
| Sex: Female, Male(Participants) | Hypo | NoHypo | Total |
|---|---|---|---|
| Female | 37 | 41 | 78 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Hypo | NoHypo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Hypo | NoHypo | Total |
|---|---|---|---|
| Turkey | 37 | 41 | 78 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The investigators do not prefer to share the study plan and records.
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Derince Training and Research Hospital