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Superior Hypogastric Blockade for Postoperative Pain

The Efficacy of Superior Hypogastric Blockade for Postoperative Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03428152
Enrollment
78
Registered
2018-02-09
Start date
2018-02-09
Completion date
2018-07-24
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Disease, Hysterectomy, Pain, Postoperative, Superior Hypogastric Plexus Block

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

PROCEDUREsuperior hypogastric block

superior hypogastric blockade during surgery

Sponsors

Derince Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Postoperative Pain Scorespostoperative 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 Consumptionpostoperative 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

MeasureTime frameDescription
Rescue Analgesic Time48 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 Operationfrom the induction of anesthesia and the end of the surgerythe time from the the first incision to the skin to skin closure.
Length of Hospital Stayassessed up to 1 weeklength of hospital stay time will be recorded
Number of Participants With Complications Due to SHP BlockFrom the SHP block time (intraoperative) until dischargeintra/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

ArmCount
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
Total78

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLack of Efficacy04
Overall StudyPhysician Decision42
Overall StudyProtocol Violation35

Baseline characteristics

CharacteristicNoHypoTotalHypo
Age, Continuous51.63 years
STANDARD_DEVIATION 7.49
52 years
STANDARD_DEVIATION 6.96
52.36 years
STANDARD_DEVIATION 6.51
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Turkey
41 Participants78 Participants37 Participants
Sex: Female, Male
Female
41 Participants78 Participants37 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 370 / 41
other
Total, other adverse events
0 / 370 / 41
serious
Total, serious adverse events
0 / 370 / 41

Outcome results

Primary

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)

ArmMeasureGroupValue (MEAN)Dispersion
HypoPostoperative Analgesic ConsumptionNSAID PACU0.8 vialsStandard Deviation 0.4
HypoPostoperative Analgesic ConsumptionOpioid PACU0.1 vialsStandard Deviation 0.3
HypoPostoperative Analgesic ConsumptionNSAID ward2.83 vialsStandard Deviation 1.23
HypoPostoperative Analgesic ConsumptionOpioid ward0 vialsStandard Deviation 0
NoHypoPostoperative Analgesic ConsumptionOpioid ward0.63 vialsStandard Deviation 0.71
NoHypoPostoperative Analgesic ConsumptionNSAID PACU0.96 vialsStandard Deviation 0.18
NoHypoPostoperative Analgesic ConsumptionNSAID ward5.77 vialsStandard Deviation 1.24
NoHypoPostoperative Analgesic ConsumptionOpioid PACU0.36 vialsStandard Deviation 0.49
Primary

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).

ArmMeasureGroupValue (MEAN)Dispersion
HypoPostoperative Pain ScoresVAS 61.9 units on a scaleStandard Deviation 1.32
HypoPostoperative Pain ScoresVAS PACU4.76 units on a scaleStandard Deviation 1.55
HypoPostoperative Pain ScoresVAS 240.53 units on a scaleStandard Deviation 0.68
HypoPostoperative Pain ScoresVAS 13.7 units on a scaleStandard Deviation 3.36
HypoPostoperative Pain ScoresVAS 480.2 units on a scaleStandard Deviation 0.4
HypoPostoperative Pain ScoresVAS 120.83 units on a scaleStandard Deviation 0.74
NoHypoPostoperative Pain ScoresVAS 481.2 units on a scaleStandard Deviation 1.39
NoHypoPostoperative Pain ScoresVAS 64.23 units on a scaleStandard Deviation 2.03
NoHypoPostoperative Pain ScoresVAS 16.66 units on a scaleStandard Deviation 2.1
NoHypoPostoperative Pain ScoresVAS 123.16 units on a scaleStandard Deviation 2.13
NoHypoPostoperative Pain ScoresVAS 242.1 units on a scaleStandard Deviation 2.17
NoHypoPostoperative Pain ScoresVAS PACU7.38 units on a scaleStandard Deviation 1.63
Secondary

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

ArmMeasureValue (MEAN)Dispersion
HypoDuration of Operation115.83 minutesStandard Deviation 34.19
NoHypoDuration of Operation114.16 minutesStandard Deviation 34.59
Secondary

Length of Hospital Stay

length of hospital stay time will be recorded

Time frame: assessed up to 1 week

ArmMeasureValue (MEAN)Dispersion
HypoLength of Hospital Stay2.66 daysStandard Deviation 0.6
NoHypoLength of Hospital Stay2.96 daysStandard Deviation 1.32
Secondary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
HypoNumber of Participants With Complications Due to SHP BlockPONV7 Participants
HypoNumber of Participants With Complications Due to SHP Blockothers0 Participants
NoHypoNumber of Participants With Complications Due to SHP BlockPONV8 Participants
NoHypoNumber of Participants With Complications Due to SHP Blockothers0 Participants
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
HypoRescue Analgesic Time627 minutesStandard Deviation 352.89
NoHypoRescue Analgesic Time203.83 minutesStandard Deviation 173.13

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026