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The purpose of this study is to assess an impact of laparoscopic superior hypogastric plexus (SHP) block combined with preemptive troacar site infiltration on postoperative pain intensity following laparoscopic myomectomy.
Patients randomized into 3 groups with a target ratio of 1:1:1 were included in the study: group 1 received standard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block; group 2 received troacar site infiltration without SHP block; control group (group 3) received standard systemic analgesia alone. The primary endpoint was presented by assessing pain intensity using the numeric rating scale (NRS) at 4 hours postoperatively. Secondary endpoints included NRS dynamics at 2, 6, 8, 12, and 24 hours postoperatively, time to first mobilization, opioid use, and pain quality assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standart analgesia | Placebo Comparator | Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics). |
|
| Troacar site infiltration | Active Comparator | Troacar site infiltration without SHP block |
|
| SHP block | Experimental | Standard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Troacar site infiltration | Procedure | Infiltration of the anterior abdominal wall is performed with placebo or 0.2% ropivacaine diluted with physiological saline on a syringe in the volume of 20 ml - 5 ml for each incision. The drug is injected with a 22-gauge needle at a 90-degree angle. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Pain syndrome intensity 4 hours after laparoscopic myomectomy. The NRS (Numeric Rating Scale) score from 0-10 is a tool for self-reporting pain intensity, where 0 equals no pain and 10 equals the worst pain imaginable. | 4 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score Dynamics | The NRS (Numeric Rating Scale) score from 0-10 is a tool for self-reporting pain intensity, where 0 equals no pain and 10 equals the worst pain imaginable. | 2, 6, 8, 12, and 24 hours postoperatively |
| Mobilization |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Petersburg State University Hospital | Saint Petersburg | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | SHP Block | Standard systemic analgesia combined with troacar site infiltration and laparoscopic superior hypogastric plexus block |
| FG001 | Troacar Site Infiltration | Troacar site infiltration without SHP block |
| FG002 | Standart Analgesia (Control Group) | Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SHP Block | Standard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block Troacar site infiltration: Infiltration of the anterior abdominal wall is performed with placebo or 0.2% ropivacaine diluted with physiological saline on a syringe in the volume of 20 ml - 5 ml for each incision. The drug is injected with a 22-gauge needle at a 90-degree angle. Superior hypogastric plexus block: At the beginning of the operation the camera is used to visualise the area of the promontorium. Next, a 1 mm laparoscopic puncture needle is inserted through a trocar in the suprapubic region and plunged into the upper part of the formed dome to a depth of no more than 1 cm. After positioning the needle retroperitoneally, an aspiration test is performed to prevent intravascular injection. Then, 20 ml of placebo or 0.2% ropivacaine diluted with physiological saline is slowly injected. At the end of the procedure, the retroperitoneal space swollen by the local anaesthetic is visualised in the promontorium. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score | Pain syndrome intensity 4 hours after laparoscopic myomectomy. The NRS (Numeric Rating Scale) score from 0-10 is a tool for self-reporting pain intensity, where 0 equals no pain and 10 equals the worst pain imaginable. | Posted | Median | Inter-Quartile Range | NRS score (0-10 scale) | 4 hours postoperatively |
|
Intraoperatively and within 48 after surgery
Adverse events were prospectively monitored intraoperatively and during the first 48 hours after surgery. Serious adverse events were predefined as organ injury, bleeding requiring transfusion, reoperation, or unplanned intensive care unit admission. Non-serious adverse events included postoperative nausea and vomiting, urinary retention, and other perioperative complications. All adverse events were collected and categorized according to severity and reported in the Adverse Events tables.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SHP Block | Standard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block |
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Patient selection followed a per-protocol design rather than an intention-to-treat approach. This strategy was chosen deliberately, as the aim was not only to assess the efficacy and safety of the proposed technique, but also to refine its application during the surgical learning curve. Such a design ensured high group homogeneity and allowed evaluation of the method under optimal procedural conditions. However, it limited the generalizability of the findings to a broader patient population, par
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nikita S. Kharlov | Saint-Petersburg State University | +7 926 283-93-77 | nikita.kharlov@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2024 | Nov 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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A single-centre prospective randomized placebo-controlled double-blind pilot study
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All patients and clinicians involved in the study are unaware of the group assignment and syringe contents.
|
| Superior hypogastric plexus block | Procedure | At the beginning of the operation the camera is used to visualise the area of the promontorium. Next, a 1 mm laparoscopic puncture needle is inserted through a trocar in the suprapubic region and plunged into the upper part of the formed dome to a depth of no more than 1 cm. After positioning the needle retroperitoneally, an aspiration test is performed to prevent intravascular injection. Then, 20 ml of placebo or 0.2% ropivacaine diluted with physiological saline is slowly injected. At the end of the procedure, the retroperitoneal space swollen by the local anaesthetic is visualised in the promontorium. |
|
Timing of post-surgery mobilization (hours after surgery)
| Early postoperative period |
| Opioid Use | Number of opioid administrations | Postoperative period, up to 48 hours |
| Pain Localisation (Superficial/Deep) | Patients were asked to characterize the predominant type of postoperative pain using a standardized questionnaire. Superficial pain was defined as somatic pain (localized, similar to muscle soreness), while deep pain was defined as visceral (diffuse, dull, similar to menstrual pain). Responses were used to evaluate the visceral pain component after surgery. Participants were allowed to report more than one type of postoperative pain. | Within 48 hours after surgery |
| conversion to laparotomy |
|
| concomitant procedure |
|
| BG001 | Troacar Site Infiltration | Troacar site infiltration without SHP block Troacar site infiltration: Infiltration of the anterior abdominal wall is performed with placebo or 0.2% ropivacaine diluted with physiological saline on a syringe in the volume of 20 ml - 5 ml for each incision. The drug is injected with a 22-gauge needle at a 90-degree angle. Superior hypogastric plexus block: At the beginning of the operation the camera is used to visualise the area of the promontorium. Next, a 1 mm laparoscopic puncture needle is inserted through a trocar in the suprapubic region and plunged into the upper part of the formed dome to a depth of no more than 1 cm. After positioning the needle retroperitoneally, an aspiration test is performed to prevent intravascular injection. Then, 20 ml of placebo or 0.2% ropivacaine diluted with physiological saline is slowly injected. At the end of the procedure, the retroperitoneal space swollen by the local anaesthetic is visualised in the promontorium. |
| BG002 | Standart Analgesia | Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics). Troacar site infiltration: Infiltration of the anterior abdominal wall is performed with placebo or 0.2% ropivacaine diluted with physiological saline on a syringe in the volume of 20 ml - 5 ml for each incision. The drug is injected with a 22-gauge needle at a 90-degree angle. Superior hypogastric plexus block: At the beginning of the operation the camera is used to visualise the area of the promontorium. Next, a 1 mm laparoscopic puncture needle is inserted through a trocar in the suprapubic region and plunged into the upper part of the formed dome to a depth of no more than 1 cm. After positioning the needle retroperitoneally, an aspiration test is performed to prevent intravascular injection. Then, 20 ml of placebo or 0.2% ropivacaine diluted with physiological saline is slowly injected. At the end of the procedure, the retroperitoneal space swollen by the local anaesthetic is visualised in the promontorium. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Operative time, min | Although intraoperative parameters such as blood loss are measured during surgery rather than strictly before the intervention, they are not used as outcome measures in this study. These variables are collected to characterize the perioperative profile of the study cohorts and to confirm group comparability in terms of surgical complexity and intraoperative burden. In addition, intraoperative parameters are analyzed as potential risk factors for the development of significant postoperative pain, together with other baseline and perioperative characteristics. | Median | Inter-Quartile Range | min |
|
| Blood loss, ml | Although intraoperative parameters such as blood loss are measured during surgery rather than strictly before the intervention, they are not used as outcome measures in this study. These variables are collected to characterize the perioperative profile of the study cohorts and to confirm group comparability in terms of surgical complexity and intraoperative burden. In addition, intraoperative parameters are analyzed as potential risk factors for the development of significant postoperative pain, together with other baseline and perioperative characteristics. | Median | Inter-Quartile Range | ml |
|
| Body mass index, kg/m^2 | Median | Inter-Quartile Range | kg/m2 |
|
| Size of the largest myoma, mm | Median | Inter-Quartile Range | mm |
|
| Standart analgesia (control group) |
Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics). |
|
|
| Secondary | Pain Score Dynamics | The NRS (Numeric Rating Scale) score from 0-10 is a tool for self-reporting pain intensity, where 0 equals no pain and 10 equals the worst pain imaginable. | Posted | Median | Inter-Quartile Range | NRS score (0-10 scale) | 2, 6, 8, 12, and 24 hours postoperatively |
|
|
|
| Secondary | Mobilization | Timing of post-surgery mobilization (hours after surgery) | Posted | Median | Inter-Quartile Range | Hours | Early postoperative period |
|
|
|
| Secondary | Opioid Use | Number of opioid administrations | Posted | Number | doses | Postoperative period, up to 48 hours |
|
|
|
| Secondary | Pain Localisation (Superficial/Deep) | Patients were asked to characterize the predominant type of postoperative pain using a standardized questionnaire. Superficial pain was defined as somatic pain (localized, similar to muscle soreness), while deep pain was defined as visceral (diffuse, dull, similar to menstrual pain). Responses were used to evaluate the visceral pain component after surgery. Participants were allowed to report more than one type of postoperative pain. | Posted | Count of Participants | Participants | Within 48 hours after surgery |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | Troacar Site Infiltration | Troacar site infiltration without SHP block | 0 | 65 | 0 | 65 | 0 | 65 |
| EG002 | Standart Analgesia (Control Group) | Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics). | 0 | 67 | 0 | 67 | 0 | 67 |
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Male |
|
|
| 8 hours postoperatively |
|
| 12 hours postoperatively |
|
| 24 hours postoperatively |
|
| Title | Measurements |
|---|---|
|