Trial Outcomes & Findings for Pre-incisional Wound INfiltration and Hypogastric PLEXus Block Using Ropivacaine in Laparoscopic Myomectomy (NCT NCT06429163)
NCT ID: NCT06429163
Last Updated: 2026-01-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
207 participants
Primary outcome timeframe
4 hours postoperatively
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
SHP Block
Standard systemic analgesia combined with troacar site infiltration and laparoscopic superior hypogastric plexus block
|
Troacar Site Infiltration
Troacar site infiltration without SHP block
|
Standart Analgesia (Control Group)
Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics).
|
|---|---|---|---|
|
Overall Study
STARTED
|
69
|
69
|
69
|
|
Overall Study
COMPLETED
|
66
|
65
|
67
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
2
|
Reasons for withdrawal
| Measure |
SHP Block
Standard systemic analgesia combined with troacar site infiltration and laparoscopic superior hypogastric plexus block
|
Troacar Site Infiltration
Troacar site infiltration without SHP block
|
Standart Analgesia (Control Group)
Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics).
|
|---|---|---|---|
|
Overall Study
uterine fibroid type 7
|
1
|
1
|
1
|
|
Overall Study
severe adhesions
|
1
|
2
|
1
|
|
Overall Study
conversion to laparotomy
|
0
|
1
|
0
|
|
Overall Study
concomitant procedure
|
1
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SHP Block
n=66 Participants
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.
|
Troacar Site Infiltration
n=65 Participants
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.
|
Standart Analgesia
n=67 Participants
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.
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.4 years
n=66 Participants
|
44.1 years
n=65 Participants
|
42.7 years
n=67 Participants
|
43.4 years
n=198 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=66 Participants
|
65 Participants
n=65 Participants
|
67 Participants
n=67 Participants
|
198 Participants
n=198 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=66 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=67 Participants
|
0 Participants
n=198 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Operative time, min
|
97.5 min
n=66 Participants
|
95 min
n=65 Participants
|
95 min
n=67 Participants
|
96 min
n=198 Participants
|
|
Blood loss, ml
|
115 ml
n=66 Participants
|
100 ml
n=65 Participants
|
100 ml
n=67 Participants
|
105 ml
n=198 Participants
|
|
Body mass index, kg/m^2
|
24.4 kg/m2
n=66 Participants
|
25.1 kg/m2
n=65 Participants
|
24.1 kg/m2
n=67 Participants
|
24.5 kg/m2
n=198 Participants
|
|
Size of the largest myoma, mm
|
68 mm
n=66 Participants
|
69 mm
n=65 Participants
|
70 mm
n=67 Participants
|
69 mm
n=198 Participants
|
PRIMARY outcome
Timeframe: 4 hours postoperativelyPain 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.
Outcome measures
| Measure |
SHP block
n=66 Participants
Standard systemic analgesia combined with troacar site infiltration and laparoscopic superior hypogastric plexus block
|
Troacar site infiltration
n=65 Participants
Troacar site infiltration without SHP block
|
Standart analgesia (control group)
n=67 Participants
Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics).
|
|---|---|---|---|
|
Pain Score
|
2 NRS score (0-10 scale)
Interval 2.0 to 3.0
|
2 NRS score (0-10 scale)
Interval 2.0 to 4.0
|
4 NRS score (0-10 scale)
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: 2, 6, 8, 12, and 24 hours postoperativelyThe 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.
Outcome measures
| Measure |
SHP block
n=66 Participants
Standard systemic analgesia combined with troacar site infiltration and laparoscopic superior hypogastric plexus block
|
Troacar site infiltration
n=65 Participants
Troacar site infiltration without SHP block
|
Standart analgesia (control group)
n=67 Participants
Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics).
|
|---|---|---|---|
|
Pain Score Dynamics
8 hours postoperatively
|
2.0 NRS score (0-10 scale)
Interval 1.5 to 2.0
|
2.0 NRS score (0-10 scale)
Interval 2.0 to 3.0
|
2.0 NRS score (0-10 scale)
Interval 2.0 to 3.5
|
|
Pain Score Dynamics
12 hours postoperatively
|
2.0 NRS score (0-10 scale)
Interval 1.0 to 2.0
|
2.0 NRS score (0-10 scale)
Interval 2.0 to 2.0
|
2.0 NRS score (0-10 scale)
Interval 2.0 to 3.0
|
|
Pain Score Dynamics
24 hours postoperatively
|
2.0 NRS score (0-10 scale)
Interval 0.5 to 2.0
|
2.0 NRS score (0-10 scale)
Interval 1.0 to 2.0
|
2.0 NRS score (0-10 scale)
Interval 1.0 to 2.5
|
|
Pain Score Dynamics
6 hours postoperatively
|
2.0 NRS score (0-10 scale)
Interval 2.0 to 3.0
|
2.0 NRS score (0-10 scale)
Interval 2.0 to 3.0
|
3.0 NRS score (0-10 scale)
Interval 2.0 to 4.0
|
|
Pain Score Dynamics
2 hours postoperatively
|
2.5 NRS score (0-10 scale)
Interval 2.0 to 4.0
|
3.0 NRS score (0-10 scale)
Interval 2.0 to 4.0
|
4.0 NRS score (0-10 scale)
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: Early postoperative periodTiming of post-surgery mobilization (hours after surgery)
Outcome measures
| Measure |
SHP block
n=66 Participants
Standard systemic analgesia combined with troacar site infiltration and laparoscopic superior hypogastric plexus block
|
Troacar site infiltration
n=65 Participants
Troacar site infiltration without SHP block
|
Standart analgesia (control group)
n=67 Participants
Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics).
|
|---|---|---|---|
|
Mobilization
|
5.0 Hours
Interval 4.0 to 7.0
|
7.0 Hours
Interval 4.0 to 13.0
|
7.0 Hours
Interval 5.0 to 11.5
|
SECONDARY outcome
Timeframe: Postoperative period, up to 48 hoursNumber of opioid administrations
Outcome measures
| Measure |
SHP block
n=66 Participants
Standard systemic analgesia combined with troacar site infiltration and laparoscopic superior hypogastric plexus block
|
Troacar site infiltration
n=65 Participants
Troacar site infiltration without SHP block
|
Standart analgesia (control group)
n=67 Participants
Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics).
|
|---|---|---|---|
|
Opioid Use
|
3 doses
|
14 doses
|
22 doses
|
SECONDARY outcome
Timeframe: Within 48 hours after surgeryPatients 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.
Outcome measures
| Measure |
SHP block
n=66 Participants
Standard systemic analgesia combined with troacar site infiltration and laparoscopic superior hypogastric plexus block
|
Troacar site infiltration
n=65 Participants
Troacar site infiltration without SHP block
|
Standart analgesia (control group)
n=67 Participants
Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics).
|
|---|---|---|---|
|
Pain Localisation (Superficial/Deep)
Superficial pain
|
30 Participants
|
15 Participants
|
21 Participants
|
|
Pain Localisation (Superficial/Deep)
Deep (visceral) pain
|
41 Participants
|
53 Participants
|
53 Participants
|
Adverse Events
SHP Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Troacar Site Infiltration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standart Analgesia (Control Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nikita S. Kharlov
Saint-Petersburg State University
Phone: +7 926 283-93-77
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place