Gynecologic Disease, Hysterectomy, Pain, Postoperative, Superior Hypogastric Plexus Block
Conditions
Keywords
superior hypogastric plexus block, hysterectomy, postoperative pain
Brief 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. 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.
Interventions
superior hypogastric blockade during surgery
Sponsors
Study design
Eligibility
Inclusion criteria
* ASA I - II * Elective hysterectomy
Exclusion criteria
* ASA III * Different kind of surgery * Known allergy to local anesthetic drugs * Different analgesia protocol (ie: epidural, TAP block,..) * Refusal of the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue Analgesic Time | 48 hours (time to the first analgesic demand will be recorded) | Time to first analgesic demand at gynecology ward (after transfer from PACU to gynecology ward) |
| Duration of Operation | from the induction of anesthesia and the end of the surgery | the time from the the first incision to the skin to skin closure. |
| Length of Hospital Stay | assessed up to 1 week | length of hospital stay time will be recorded |
| Number of Participants With Complications Due to SHP Block | From the SHP block time (intraoperative) until discharge | 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,.. ) |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hypo The participants with a superior hypogastric block
superior hypogastric block: superior hypogastric blockade during surgery | 37 |
| 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) | 41 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 4 |
| Overall Study | Physician Decision | 4 | 2 |
| Overall Study | Protocol Violation | 3 | 5 |
Baseline characteristics
| Characteristic | NoHypo | Total | Hypo |
|---|---|---|---|
| Age, Continuous | 51.63 years STANDARD_DEVIATION 7.49 | 52 years STANDARD_DEVIATION 6.96 | 52.36 years STANDARD_DEVIATION 6.51 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Turkey | 41 Participants | 78 Participants | 37 Participants |
| Sex: Female, Male Female | 41 Participants | 78 Participants | 37 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 41 |
| other Total, other adverse events | 0 / 37 | 0 / 41 |
| serious Total, serious adverse events | 0 / 37 | 0 / 41 |
Outcome results
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hypo | Postoperative Analgesic Consumption | NSAID PACU | 0.8 vials | Standard Deviation 0.4 |
| Hypo | Postoperative Analgesic Consumption | Opioid PACU | 0.1 vials | Standard Deviation 0.3 |
| Hypo | Postoperative Analgesic Consumption | NSAID ward | 2.83 vials | Standard Deviation 1.23 |
| Hypo | Postoperative Analgesic Consumption | Opioid ward | 0 vials | Standard Deviation 0 |
| NoHypo | Postoperative Analgesic Consumption | Opioid ward | 0.63 vials | Standard Deviation 0.71 |
| NoHypo | Postoperative Analgesic Consumption | NSAID PACU | 0.96 vials | Standard Deviation 0.18 |
| NoHypo | Postoperative Analgesic Consumption | NSAID ward | 5.77 vials | Standard Deviation 1.24 |
| NoHypo | Postoperative Analgesic Consumption | Opioid PACU | 0.36 vials | Standard Deviation 0.49 |
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)
Population: 37 patients with a superior hypogastric block (7 was excluded); 41 patients without a superior hypogastric block (11 was excluded).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hypo | Postoperative Pain Scores | VAS 6 | 1.9 units on a scale | Standard Deviation 1.32 |
| Hypo | Postoperative Pain Scores | VAS PACU | 4.76 units on a scale | Standard Deviation 1.55 |
| Hypo | Postoperative Pain Scores | VAS 24 | 0.53 units on a scale | Standard Deviation 0.68 |
| Hypo | Postoperative Pain Scores | VAS 1 | 3.7 units on a scale | Standard Deviation 3.36 |
| Hypo | Postoperative Pain Scores | VAS 48 | 0.2 units on a scale | Standard Deviation 0.4 |
| Hypo | Postoperative Pain Scores | VAS 12 | 0.83 units on a scale | Standard Deviation 0.74 |
| NoHypo | Postoperative Pain Scores | VAS 48 | 1.2 units on a scale | Standard Deviation 1.39 |
| NoHypo | Postoperative Pain Scores | VAS 6 | 4.23 units on a scale | Standard Deviation 2.03 |
| NoHypo | Postoperative Pain Scores | VAS 1 | 6.66 units on a scale | Standard Deviation 2.1 |
| NoHypo | Postoperative Pain Scores | VAS 12 | 3.16 units on a scale | Standard Deviation 2.13 |
| NoHypo | Postoperative Pain Scores | VAS 24 | 2.1 units on a scale | Standard Deviation 2.17 |
| NoHypo | Postoperative Pain Scores | VAS PACU | 7.38 units on a scale | Standard Deviation 1.63 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypo | Duration of Operation | 115.83 minutes | Standard Deviation 34.19 |
| NoHypo | Duration of Operation | 114.16 minutes | Standard Deviation 34.59 |
Length of Hospital Stay
length of hospital stay time will be recorded
Time frame: assessed up to 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypo | Length of Hospital Stay | 2.66 days | Standard Deviation 0.6 |
| NoHypo | Length of Hospital Stay | 2.96 days | Standard Deviation 1.32 |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypo | Number of Participants With Complications Due to SHP Block | PONV | 7 Participants |
| Hypo | Number of Participants With Complications Due to SHP Block | others | 0 Participants |
| NoHypo | Number of Participants With Complications Due to SHP Block | PONV | 8 Participants |
| NoHypo | Number of Participants With Complications Due to SHP Block | others | 0 Participants |
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypo | Rescue Analgesic Time | 627 minutes | Standard Deviation 352.89 |
| NoHypo | Rescue Analgesic Time | 203.83 minutes | Standard Deviation 173.13 |