Fibroid Uterus, Pain, Postoperative
Conditions
Keywords
Uterine fibroid, Laparoscopic myomectomy, Postoperative pain, Pre-incisional infiltration, Hypogastric plexus block, EQ-5D questionnaire, Picker questionnaire, The Central Sensitization Inventory (CSI-R)
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURETroacar 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.
PROCEDURESuperior 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.
Sponsors
Saint Petersburg State University, Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
All patients and clinicians involved in the study are unaware of the group assignment and syringe contents.
Intervention model description
A single-centre prospective randomized placebo-controlled double-blind pilot study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women aged ≥18 years. * Indication for laparoscopic myomectomy due to ≥6 cm fibroid(s) or multiple fibroids. * Ability to provide informed consent.
Exclusion criteria
* FIGO type 7 subserosal pedunculated myoma. * Conversion to laparotomy. * Severe presacral adhesions preventing safe SHPB. * Concomitant pelvic or abdominal surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 4 hours postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Dynamics | 2, 6, 8, 12, and 24 hours postoperatively | 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. |
| Mobilization | Early postoperative period | Timing of post-surgery mobilization (hours after surgery) |
| Opioid Use | Postoperative period, up to 48 hours | Number of opioid administrations |
| Pain Localisation (Superficial/Deep) | Within 48 hours after surgery | 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. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 66 |
| 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. | 65 |
| 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. | 67 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | concomitant procedure | 1 | 0 | 0 |
| Overall Study | conversion to laparotomy | 0 | 1 | 0 |
| Overall Study | severe adhesions | 1 | 2 | 1 |
| Overall Study | uterine fibroid type 7 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | SHP Block | Troacar Site Infiltration | Standart Analgesia | Total |
|---|---|---|---|---|
| Age, Continuous | 44.4 years | 44.1 years | 42.7 years | 43.4 years |
| Blood loss, ml | 115 ml | 100 ml | 100 ml | 105 ml |
| Body mass index, kg/m^2 | 24.4 kg/m2 | 25.1 kg/m2 | 24.1 kg/m2 | 24.5 kg/m2 |
| Operative time, min | 97.5 min | 95 min | 95 min | 96 min |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 66 Participants | 65 Participants | 67 Participants | 198 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Size of the largest myoma, mm | 68 mm | 69 mm | 70 mm | 69 mm |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 65 | 0 / 67 |
| other Total, other adverse events | 0 / 66 | 0 / 65 | 0 / 67 |
| serious Total, serious adverse events | 0 / 66 | 0 / 65 | 0 / 67 |
Outcome results
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.
Time frame: 4 hours postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SHP block | Pain Score | 2 NRS score (0-10 scale) |
| Troacar site infiltration | Pain Score | 2 NRS score (0-10 scale) |
| Standart analgesia (control group) | Pain Score | 4 NRS score (0-10 scale) |
Secondary
Mobilization
Timing of post-surgery mobilization (hours after surgery)
Time frame: Early postoperative period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SHP block | Mobilization | 5.0 Hours |
| Troacar site infiltration | Mobilization | 7.0 Hours |
| Standart analgesia (control group) | Mobilization | 7.0 Hours |
Secondary
Opioid Use
Number of opioid administrations
Time frame: Postoperative period, up to 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SHP block | Opioid Use | 3 doses |
| Troacar site infiltration | Opioid Use | 14 doses |
| Standart analgesia (control group) | Opioid Use | 22 doses |
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.
Time frame: Within 48 hours after surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SHP block | Pain Localisation (Superficial/Deep) | Superficial pain | 30 Participants |
| SHP block | Pain Localisation (Superficial/Deep) | Deep (visceral) pain | 41 Participants |
| Troacar site infiltration | Pain Localisation (Superficial/Deep) | Superficial pain | 15 Participants |
| Troacar site infiltration | Pain Localisation (Superficial/Deep) | Deep (visceral) pain | 53 Participants |
| Standart analgesia (control group) | Pain Localisation (Superficial/Deep) | Superficial pain | 21 Participants |
| Standart analgesia (control group) | Pain Localisation (Superficial/Deep) | Deep (visceral) pain | 53 Participants |
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.
Time frame: 2, 6, 8, 12, and 24 hours postoperatively
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SHP block | Pain Score Dynamics | 12 hours postoperatively | 2.0 NRS score (0-10 scale) |
| SHP block | Pain Score Dynamics | 8 hours postoperatively | 2.0 NRS score (0-10 scale) |
| SHP block | Pain Score Dynamics | 2 hours postoperatively | 2.5 NRS score (0-10 scale) |
| SHP block | Pain Score Dynamics | 6 hours postoperatively | 2.0 NRS score (0-10 scale) |
| SHP block | Pain Score Dynamics | 24 hours postoperatively | 2.0 NRS score (0-10 scale) |
| Troacar site infiltration | Pain Score Dynamics | 8 hours postoperatively | 2.0 NRS score (0-10 scale) |
| Troacar site infiltration | Pain Score Dynamics | 2 hours postoperatively | 3.0 NRS score (0-10 scale) |
| Troacar site infiltration | Pain Score Dynamics | 6 hours postoperatively | 2.0 NRS score (0-10 scale) |
| Troacar site infiltration | Pain Score Dynamics | 12 hours postoperatively | 2.0 NRS score (0-10 scale) |
| Troacar site infiltration | Pain Score Dynamics | 24 hours postoperatively | 2.0 NRS score (0-10 scale) |
| Standart analgesia (control group) | Pain Score Dynamics | 24 hours postoperatively | 2.0 NRS score (0-10 scale) |
| Standart analgesia (control group) | Pain Score Dynamics | 12 hours postoperatively | 2.0 NRS score (0-10 scale) |
| Standart analgesia (control group) | Pain Score Dynamics | 2 hours postoperatively | 4.0 NRS score (0-10 scale) |
| Standart analgesia (control group) | Pain Score Dynamics | 8 hours postoperatively | 2.0 NRS score (0-10 scale) |
| Standart analgesia (control group) | Pain Score Dynamics | 6 hours postoperatively | 3.0 NRS score (0-10 scale) |