Total Laparoscopic HysterectomyNCT07078643
Comparison of the Effects of Blocks on Postoperative Analgesia in Total Laparoscopic Hysterectomy Surgery
A study testing Superior Hypogastric Plexus Block (SHPB) and Erector Spinae Plane Block (ESPB) in people with Total Laparoscopic Hysterectomy, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Total laparoscopic hysterectomy (TLH) is one of the most commonly performed gynecological surgeries today. Various analgesic techniques are used for the management of postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Total Laparoscopic Hysterectomy
- What is being tested?
- Superior Hypogastric Plexus Block (SHPB) and Erector Spinae Plane Block (ESPB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 31 Mar 2023
- Phase
- Interventional
- 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
Who may be able to join
- Female patients aged between 18 and 65 years
- Scheduled for elective total laparoscopic hysterectomy (TLH)
- Classified as American Society of Anesthesiologists (ASA) physical status I or II
- Able to provide written informed consent in accordance with the Declaration of Helsinki
Who cannot join
- Refusal to participate or inability to provide informed consent
- Body mass index (BMI) ≥ 35 kg/m²
- Inability to cooperate or follow instructions
- Presence of spinal or paravertebral deformity
- Known coagulopathy or use of anticoagulant therapy
- Known hypersensitivity or allergy to local anesthetic drugs used in the study
- Requirement for postoperative intensive care
- History of chronic opioid use (longer than four weeks prior to surgery)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lütfi Kırdar Training and Research Hospital
Istanbul, 34862
About this study
Official title: Comparison of the Effects of Superior Hypogastric Plexus Block and Erector Spinae Plane Block on Postoperative Analgesia in Total Laparoscopic Hysterectomy Surgery
Total laparoscopic hysterectomy (TLH) is one of the most commonly performed gynecological surgeries today. Various analgesic techniques are used for the management of postoperative pain. The aim of this study is to compare the postoperative analgesic efficacy of superior hypogastric plexus block (SHPB) and erector spinae plane block (ESPB) in patients undergoing TLH procedures.
Read the detailed description
This prospective, randomized, double-blind, single-center clinical trial aims to compare the postoperative analgesic efficacy of Superior Hypogastric Plexus Block (SHPB) and Erector Spinae Plane Block (ESPB) in patients undergoing total laparoscopic hysterectomy (TLH).
Following ethics committee approval (2022/514/220/10), the study was conducted between March 2022 and March 2023. Patients aged 18 to 65 years, classified as ASA physical status I-II and scheduled for elective TLH, were enrolled. Participants were randomly assigned into three groups using computer-generated randomization (n=30 per group): SHPB, ESPB, and Control. Both the anesthesiologist performing postoperative evaluations and the patients were blinded to group allocation.
All patients received general anesthesia in accordance with a standardized protocol.
ESPB was performed bilaterally at the T10 level under ultrasound guidance. SHPB was performed laparoscopically at the L5-S1 level after uterine removal. No regional block was applied in the control group.
Postoperative pain management was provided to all patients via patient-controlled analgesia (PCA). Pain levels were evaluated using the Visual Analog Scale (VAS) at postoperative 0, 30, 60, 90, and 120 minutes, and at 6, 12, and 24 hours.
This study aims to investigate whether SHPB provides more effective visceral analgesia compared to ESPB and whether this leads to reduced opioid requirements and improved patient satisfaction following TLH.
- Conditions
- Total Laparoscopic Hysterectomy
- Being tested
- Superior Hypogastric Plexus Block (SHPB), Erector Spinae Plane Block (ESPB)
- Keywords
- Postoperative Pain, Erector Spinae Plane Block, Superior Hypogastric Plexus Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superior Hypogastric Plexus Block (SHPB)Procedure or surgery
Laparoscopic superior hypogastric plexus block with bupivacaine and lidocaine injection near sacral promontory.
Erector Spinae Plane Block (ESPB)Procedure or surgery
Erector spinae plane block with ultrasound-guided injection of bupivacaine and lidocaine at T10 level.
| Study group | Role | What they receive |
|---|---|---|
| Superior Hypogastric Plexus Block (SHPB) Group | Active comparator | SHPB Group: In this group, patients received a superior hypogastric plexus block (SHPB) following total laparoscopic hysterectomy. After uterus removal and vaginal cuff closure, and before trocar removal, the injection site was identified laparoscopically. The block was performed in all patients by a single surgeon experienced in SHPB. Receives: Procedure: Superior Hypogastric Plexus Block (SHPB) |
| Erector Spinae Plane Block Group | Active comparator | ESPB Group: Patients in this group received erector spinae plane block (ESPB) during anesthesia maintenance after surgery. Patients were positioned in the lateral decubitus position. At the T10 level, the ultrasound probe was placed in the midline to identify spinous processes, then moved 2-3 cm laterally to visualize the transverse process, trapezius, and erector spinae muscles. The same procedure was performed on the opposite side. All blocks were performed by a single anesthesiologist experienced in ESPB. Receives: Procedure: Erector Spinae Plane Block (ESPB) |
| Control Group | No intervention | Control Group: Patients in this group did not receive any block and were managed with standard postoperative care only. This group served as the comparison group to evaluate the effects of the block interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Tramadol Consumption
The total amount of tramadol administered via a patient-controlled analgesia (PCA) device within the first 24 hours after total laparoscopic hysterectomy. This measurement is used to compare the postoperative analgesic efficacy of superior hypogastric plexus block (SHPB) and erector spinae plane block (ESPB) with the control group receiving no block. Tramadol consumption is recorded in milligrams (mg) and extracted directly from PCA device logs.
Measured: Postoperative 0-24 hours
Secondary outcomes (3)
Postoperative Pain Intensity (VAS Scores)
Pain levels will be measured using the Visual Analog Scale (VAS), a 10 cm horizontal line labeled "no pain" at 0 cm and "worst imaginable pain" at 10 cm. Patients will indicate their pain intensity at postoperative time points (e.g., 1h, 6h, 12h, 24h). The score is determined by measuring the distance in centimeters from the "no pain" anchor to the patient's mark. Higher scores indicate greater pain intensity.
Measured: Postoperative 0-24 hours
Time to First Rescue Analgesia
Duration from the end of surgery to the time the patient first requests additional analgesia beyond the standard postoperative regimen.
Measured: Postoperative 0-24 hours
Incidence of Postoperative Nausea and Vomiting (PONV)
The proportion of patients experiencing nausea and/or vomiting within the first 24 hours after surgery.
Measured: Postoperative 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Mar 2022
- Primary completion23 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Laparoscopic HysterectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- "This study uses a parallel design where participants are randomly assigned to one of three groups: Superior Hypogastric Plexus Block (SHPB), Erector Spinae Plane Block (ESPB), or Control group. Each group receives its respective intervention or no block in the control group. Outcomes are measured postoperatively to compare analgesic efficacy among groups."
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MACİD ORDU, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Macid Ordu, MD, Principal investigator, Kartal Dr. Lütfi Kırdar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078643
- Sponsor's protocol ID
- DrLutfiKirdarTRH-MO-01
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data due to institutional data protection policies and ethical considerations related to participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Superior Hypogastric Plexus Block and Erector Spinae Plane Block on Postoperative Analgesia in Total Laparoscopic Hysterectomy Surgery
- ClinicalTrials.gov ID
- NCT07078643
- Acronym / sponsor ID
- DrLutfiKirdarTRH-MO-01
- Conditions
- Total Laparoscopic Hysterectomy
- Keywords
- Postoperative Pain, Erector Spinae Plane Block, Superior Hypogastric Plexus Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 22 Jul 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.
Total laparoscopic hysterectomy (TLH) is one of the most commonly performed gynecological surgeries today. Various analgesic techniques are used for the management of postoperative pain. The aim of this study is to compare the postoperative analgesic efficacy of superior hypogastric plexus block (SHPB) and erector spinae plane block (ESPB) in patients undergoing TLH procedures.
Detailed description
This prospective, randomized, double-blind, single-center clinical trial aims to compare the postoperative analgesic efficacy of Superior Hypogastric Plexus Block (SHPB) and Erector Spinae Plane Block (ESPB) in patients undergoing total laparoscopic hysterectomy (TLH).
Following ethics committee approval (2022/514/220/10), the study was conducted between March 2022 and March 2023. Patients aged 18 to 65 years, classified as ASA physical status I-II and scheduled for elective TLH, were enrolled. Participants were randomly assigned into three groups using computer-generated randomization (n=30 per group): SHPB, ESPB, and Control. Both the anesthesiologist performing postoperative evaluations and the patients were blinded to group allocation.
All patients received general anesthesia in accordance with a standardized protocol.
ESPB was performed bilaterally at the T10 level under ultrasound guidance. SHPB was performed laparoscopically at the L5-S1 level after uterine removal. No regional block was applied in the control group.
Postoperative pain management was provided to all patients via patient-controlled analgesia (PCA). Pain levels were evaluated using the Visual Analog Scale (VAS) at postoperative 0, 30, 60, 90, and 120 minutes, and at 6, 12, and 24 hours.
This study aims to investigate whether SHPB provides more effective visceral analgesia compared to ESPB and whether this leads to reduced opioid requirements and improved patient satisfaction following TLH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- "This study uses a parallel design where participants are randomly assigned to one of three groups: Superior Hypogastric Plexus Block (SHPB), Erector Spinae Plane Block (ESPB), or Control group. Each group receives its respective intervention or no block in the control group. Outcomes are measured postoperatively to compare analgesic efficacy among groups."
| Arm | Type | Receives |
|---|---|---|
| Superior Hypogastric Plexus Block (SHPB) Group | Active comparator | Procedure: Superior Hypogastric Plexus Block (SHPB)SHPB Group: In this group, patients received a superior hypogastric plexus block (SHPB) following total laparoscopic hysterectomy. After uterus removal and vaginal cuff closure, and before trocar removal, the injection site was identified laparoscopically. The block was performed in all patients by a single surgeon experienced in SHPB. |
| Erector Spinae Plane Block Group | Active comparator | Procedure: Erector Spinae Plane Block (ESPB)ESPB Group: Patients in this group received erector spinae plane block (ESPB) during anesthesia maintenance after surgery. Patients were positioned in the lateral decubitus position. At the T10 level, the ultrasound probe was placed in the midline to identify spinous processes, then moved 2-3 cm laterally to visualize the transverse process, trapezius, and erector spinae muscles. The same procedure was performed on the opposite side. All blocks were performed by a single anesthesiologist experienced in ESPB. |
| Control Group | No intervention | –Control Group: Patients in this group did not receive any block and were managed with standard postoperative care only. This group served as the comparison group to evaluate the effects of the block interventions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged between 18 and 65 years
- Scheduled for elective total laparoscopic hysterectomy (TLH)
- Classified as American Society of Anesthesiologists (ASA) physical status I or II
- Able to provide written informed consent in accordance with the Declaration of Helsinki
Key exclusion criteria (8 listed)
- Refusal to participate or inability to provide informed consent
- Body mass index (BMI) ≥ 35 kg/m²
- Inability to cooperate or follow instructions
- Presence of spinal or paravertebral deformity
- Known coagulopathy or use of anticoagulant therapy
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 Plexus Block (SHPB)Laparoscopic superior hypogastric plexus block with bupivacaine and lidocaine injection near sacral promontory. | Procedure or surgery | Superior Hypogastric Plexus Block (SHPB) Group |
| Erector Spinae Plane Block (ESPB)Erector spinae plane block with ultrasound-guided injection of bupivacaine and lidocaine at T10 level. | Procedure or surgery | Erector Spinae Plane Block Group |
Primary outcome
Total Tramadol Consumption
Time frame: Postoperative 0-24 hours
The total amount of tramadol administered via a patient-controlled analgesia (PCA) device within the first 24 hours after total laparoscopic hysterectomy. This measurement is used to compare the postoperative analgesic efficacy of superior hypogastric plexus block (SHPB) and erector spinae plane block (ESPB) with the control group receiving no block. Tramadol consumption is recorded in milligrams (mg) and extracted directly from PCA device logs.
3 secondary outcomes
Postoperative Pain Intensity (VAS Scores)
Time frame: Postoperative 0-24 hours
Time to First Rescue Analgesia
Time frame: Postoperative 0-24 hours
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: Postoperative 0-24 hours
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 24 Jul 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data due to institutional data protection policies and ethical considerations related to participant privacy.
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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.
Macid Ordu, MD principal investigator
Kartal Dr. Lütfi Kırdar 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?
A study testing Superior Hypogastric Plexus Block (SHPB) and Erector Spinae Plane Block (ESPB) in people with Total Laparoscopic Hysterectomy, run by Dr. Lutfi Kirdar Kartal 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 4 inclusion and 8 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 24 Jul 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?
Total Tramadol Consumption (time frame: Postoperative 0-24 hours). 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 24 Jul 2025.