Superior Hypogastric Plexus BlockNCT06954896
Comparison of Superior Hypogastric Plexus Block and Peritoneal Bupivacaine in Pain Management
An observational study of Superior Hypogastric Plexus Block and Intraperitoneal Bupivacaine, run by Enes Celik at 1 site in Turkey (Türkiye).
Trial summary
Background: Laparoscopic hysterectomy is one of the most frequently performed major surgeries in nonmalignant gynecological diseases. Effective postoperative analgesia is associated with short hospital stays, early mobilization, reduced costs, and patient satisfaction. 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, Intraperitoneal Bupivacaine
- What is being tested?
- Bupivacain, Dexketoprofen (KETAVEL 50 mg/2 ml) and Intraperitoneal Bupivacaine spray
- Type of treatment
- Injection or infusion
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 20 Feb 2025
- 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 study population comprised patients who underwent laparoscopic hysterectomy-with or without oophorectomy-for benign indications (such as myoma uteri, dysfunctional uterine bleeding, uterine prolapse, or precancerous cervical lesions) between July 2024 and December 2024, and who were classified as ASA physical status I-II. Patients were excluded if they were younger than 18 or older than 65, underwent epidural catheterisation and/or received additional pain management modalities (e.g., transversus abdominis plane block, local wound infiltration, quadratus lumborum block), had surgery for malignancy, underwent a different surgical approach (e.g., transvaginal natural orifice transluminal endoscopic surgery), or were prescribed preoperative antidepressants or gabapentinoids.
Who may be able to join
- patients who underwent laparoscopic hysterectomy-with or without oophorectomy-
- ASA physical status I-II patients
Who cannot join
- women with known bupivacaine allergy, anxiety-depressive disorders, fibromyalgia, coagulopathy, eclampsia/preeclampsia, or those who were pregnant were also excluded.
- if they were younger than 18 or older than 65
- underwent epidural catheterisation and/or received additional pain management modalities
- prescribed preoperative antidepressants or gabapentinoids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Superior Hypogastric Plexus Block and Peritoneal Bupivacaine in Pain Management After Laparoscopic Hysterectomy
Background: Laparoscopic hysterectomy is one of the most frequently performed major surgeries in nonmalignant gynecological diseases. Effective postoperative analgesia is associated with short hospital stays, early mobilization, reduced costs, and patient satisfaction. Intravenous administration of nonsteroidal anti-inflammatory drugs, paracetamol or opioids; epidural catheter placement; peritoneal local anaesthetic administration; and superior hypogastric plexus block (SHPB) are routinely employed methods for postoperative pain management following laparoscopic hysterectomy.
Methods: The study population comprised patients who underwent laparoscopic hysterectomy with or without oophorectomy for benign indications. A total of 94 patients were included in the study. Thirty patients received a superior hypogastric plexus block, thirty received intraperitoneal local anaesthetic spray, and thirty-four received intravenous analgesics.
Conclusion: In the present study, a comparison of postoperative pain management in patients who underwent laparoscopic hysterectomy was conducted.
Read the detailed description
In the present study, a comparison of postoperative pain management in patients who underwent laparoscopic hysterectomy was conducted. The findings indicated that the initial postoperative administration of analgesics occurred later in patients who received peritoneal local anesthetics and SHPB compared to the control group. In addition, VAS values at the first and third hours were found to be lower in the peritoneal local anesthetic and SHPB groups than in the control group. Postoperative pain experienced by patients following gynecologic surgery. It has been reported that approximately 75% of patients experience severe pain. Excessive opioid use in postoperative pain management and the potential for additional complications are also possible. One of the alternative methods to reduce postoperative opioid use is intraperitoneal bupivacaine administration.
- Being tested
- Bupivacain, Dexketoprofen (KETAVEL 50 mg/2 ml), Intraperitoneal Bupivacaine spray
- Keywords
- Hypogastric Plexus, Hysterectomy, Intraperitoneal Injections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
The superior hypogastric plexus block (SHPB) was performed following uterine removal and closure of the vaginal cuff, but prior to trocar removal from the abdominal cavity. The promontory was identified under laparoscopic visualization. The posterior peritoneum overlying the promontory was gently grasped and elevated with an instrument to create a peritoneal tent. A needle was then inserted at the apex of the tent and advanced approximately 1 cm. At this point, a subperitoneal space was further expanded using a surgical instrument, and 30 ml of 0.25% bupivacaine was injected into the area
Dexketoprofen (KETAVEL 50 mg/2 ml)Drug
In cases where the VAS score exceeded 3 in the postoperative period, it was deemed that the patient's analgesia was insufficient, prompting the intravenous administration of 50 mg of dexketoprofen sodium.
Intraperitoneal Bupivacaine sprayDrug
The peritoneal cavity and abdominal wall were treated with 30 milliliters of 0.25% bupivacaine, with a focus on areas involving the peritoneum in the lower abdominal region.
| Study group | Role | What they receive |
|---|---|---|
| intraperitoneal local anaesthetic spray (Group B) | Not described Receives: Drug: Intraperitoneal Bupivacaine spray | |
| intravenous analgesics (Group C) | Not described Receives: Drug: Dexketoprofen (KETAVEL 50 mg/2 ml) | |
| superior hypogastric plexus block (Group S) | Not described Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (vısual analog scale)
For patients with no pain, VAS was recorded as 0 (zero), and for those with unbearable pain, VAS was recorded as 10 (ten).
Measured: 24 HOUR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start1 Jul 2024
- Primary completion30 Dec 2024
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enes Celik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enes Celik, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954896
- Sponsor's protocol ID
- ArtukluU-MED-EC-01
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Superior Hypogastric Plexus Block and Peritoneal Bupivacaine in Pain Management After Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT06954896
- Acronym / sponsor ID
- ArtukluU-MED-EC-01
- Keywords
- Hypogastric Plexus, Hysterectomy, Intraperitoneal Injections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Enes CelikUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 2 May 2025 (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.
Background: Laparoscopic hysterectomy is one of the most frequently performed major surgeries in nonmalignant gynecological diseases. Effective postoperative analgesia is associated with short hospital stays, early mobilization, reduced costs, and patient satisfaction. Intravenous administration of nonsteroidal anti-inflammatory drugs, paracetamol or opioids; epidural catheter placement; peritoneal local anaesthetic administration; and superior hypogastric plexus block (SHPB) are routinely employed methods for postoperative pain management following laparoscopic hysterectomy.
Methods: The study population comprised patients who underwent laparoscopic hysterectomy with or without oophorectomy for benign indications. A total of 94 patients were included in the study. Thirty patients received a superior hypogastric plexus block, thirty received intraperitoneal local anaesthetic spray, and thirty-four received intravenous analgesics.
Conclusion: In the present study, a comparison of postoperative pain management in patients who underwent laparoscopic hysterectomy was conducted.
Detailed description
In the present study, a comparison of postoperative pain management in patients who underwent laparoscopic hysterectomy was conducted. The findings indicated that the initial postoperative administration of analgesics occurred later in patients who received peritoneal local anesthetics and SHPB compared to the control group. In addition, VAS values at the first and third hours were found to be lower in the peritoneal local anesthetic and SHPB groups than in the control group. Postoperative pain experienced by patients following gynecologic surgery. It has been reported that approximately 75% of patients experience severe pain. Excessive opioid use in postoperative pain management and the potential for additional complications are also possible. One of the alternative methods to reduce postoperative opioid use is intraperitoneal bupivacaine administration.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intraperitoneal local anaesthetic spray (Group B) | – | Drug: Intraperitoneal Bupivacaine spray |
| intravenous analgesics (Group C) | – | Drug: Dexketoprofen (KETAVEL 50 mg/2 ml) |
| superior hypogastric plexus block (Group S) | – | Drug: Bupivacain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprised patients who underwent laparoscopic hysterectomy-with or without oophorectomy-for benign indications (such as myoma uteri, dysfunctional uterine bleeding, uterine prolapse, or precancerous cervical lesions) between July 2024 and December 2024, and who were classified as ASA physical status I-II. Patients were excluded if they were younger than 18 or older than 65, underwent epidural catheterisation and/or received additional pain management modalities (e.g., transversus abdominis plane block, local wound infiltration, quadratus lumborum block), had surgery for malignancy, underwent a different surgical approach (e.g., transvaginal natural orifice transluminal endoscopic surgery), or were prescribed preoperative antidepressants or gabapentinoids.
Key inclusion criteria (2 listed)
- patients who underwent laparoscopic hysterectomy-with or without oophorectomy-
- ASA physical status I-II patients
Key exclusion criteria (4 listed)
- women with known bupivacaine allergy, anxiety-depressive disorders, fibromyalgia, coagulopathy, eclampsia/preeclampsia, or those who were pregnant were also excluded.
- if they were younger than 18 or older than 65
- underwent epidural catheterisation and/or received additional pain management modalities
- prescribed preoperative antidepressants or gabapentinoids
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 |
|---|---|---|
| BupivacainThe superior hypogastric plexus block (SHPB) was performed following uterine removal and closure of the vaginal cuff, but prior to trocar removal from the abdominal cavity. The promontory was identified under laparoscopic visualization. The posterior peritoneum overlying the promontory was gently grasped and elevated with an instrument to create a peritoneal tent. A needle was then inserted at the apex of the tent and advanced approximately 1 cm. At this point, a subperitoneal space was further expanded using a surgical instrument, and 30 ml of 0.25% bupivacaine was injected into the area | Drug | superior hypogastric plexus block (Group S) |
| Dexketoprofen (KETAVEL 50 mg/2 ml)In cases where the VAS score exceeded 3 in the postoperative period, it was deemed that the patient's analgesia was insufficient, prompting the intravenous administration of 50 mg of dexketoprofen sodium. | Drug | intravenous analgesics (Group C) |
| Intraperitoneal Bupivacaine sprayThe peritoneal cavity and abdominal wall were treated with 30 milliliters of 0.25% bupivacaine, with a focus on areas involving the peritoneum in the lower abdominal region. | Drug | intraperitoneal local anaesthetic spray (Group B) |
Primary outcome
VAS (vısual analog scale)
Time frame: 24 HOUR
For patients with no pain, VAS was recorded as 0 (zero), and for those with unbearable pain, VAS was recorded as 10 (ten).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intraperitoneal Bupivacaine, run by Enes Celik 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 4 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 2 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VAS (vısual analog scale) (time frame: 24 HOUR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2025.