Impact of Pre-incisional Wound Infiltration and Hypogastric Plexus Block Using Ropivacaine on Postoperative Pain Following Laparoscopic Myomectomy: A Single-Center, Prospective, Randomized, Placebo-Controlled, Double-Blind Study
Phase: NA
Conditions: Fibroid Uterus, Pain, Postoperative
Sponsor: Saint Petersburg State University, Russia

 
Saint Petersburg State University Hospital 
 
 
Study Protocol 
 
Pre-incisional Wound INfiltration and Hypogastric PLEXus 
Block Using Ropivacaine in Laparoscopic Myomectomy  
A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial 
NCT06429163 
 
Principal Investigator: 
Nikita S. Kharlov, MD 
 
 
 
 
 
 
 
 
 
Saint Petersburg 
April 12, 2024 
 
 

Background and Rationale 
Uterine leiomyomas represent the most common benign tumor of the female 
reproductive system, with prevalence rates reaching up to 77% among women of 
reproductive age (1). Although symptomatic in only 20–50% of cases, fibroids 
substantially affect quality of life and reproductive potential (2). 
Laparoscopic myomectomy is the current gold standard for fertility-preserving 
surgical management of fibroids. Its minimally invasive nature aligns well with 
Enhanced Recovery After Surgery (ERAS) principles, reducing surgical trauma, 
lowering postoperative pain, and facilitating earlier mobilization (3). 
Effective 
perioperative 
analgesia 
is 
fundamental 
to 
successful 
ERAS 
implementation. Standard regimens rely heavily on NSAIDs, acetaminophen, and 
opioids. However, opioid use may undermine recovery by causing sedation, nausea, 
vomiting, ileus, impaired mobilization, and possibly opioid-induced hyperalgesia or 
immunosuppression (4). 
Pain after laparoscopic myomectomy is multifactorial. Given the complex somatic 
and visceral innervation of the uterus—including sympathetic fibers traveling 
through the superior hypogastric plexus—traditional infiltration analgesia may not 
adequately address the visceral component (5). 
Superior hypogastric plexus block (SHPB) has demonstrated analgesic efficacy in 
patients with pelvic malignancies, dysmenorrhea, endometriosis, and following 
abdominal hysterectomy or cesarean delivery (6). Yet its preventive use in 
laparoscopic myomectomy has never been systematically assessed. 
This study evaluates whether combining pre-incisional wound infiltration with an 
intraoperative SHPB using ropivacaine can improve postoperative pain control 
compared with standard approaches. 

Study Objective 
The aim 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 
Study Design 
This is a single-center, prospective, randomized, double-blind, placebo-
controlled, three-arm trial. 
Participants are randomized 1:1:1 into: 
1. Group A (Full Analgesia): 
Pre-incisional wound infiltration + SHPB with 0.2% ropivacaine. 
2. Group B (Wound Analgesia Only): 
Wound infiltration with ropivacaine + SHPB with placebo. 
3. Group C (Placebo): 
Placebo for both wound infiltration and SHPB. 
Randomization is performed using Sealed Envelope® with opaque sequentially 
numbered envelopes. Allocation is concealed from investigators, surgeons, 
anesthesiologists, and study personnel. Only an anesthesiologist not involved in 
patient care opens the envelope and prepares syringes. 

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. 
Interventions 
Surgical Procedure 
All participants undergo standardized laparoscopic myomectomy performed under 
uniform technique using harmonic scalpel dissection, multilayer myometrial 
closure, and in-bag morcellation. No drains are placed. 
Analgesic Interventions 
Wound Infiltration 
Ropivacaine or placebo is administered pre-incision using a patented method: 
infiltration volume (mL) equals the incision length (mm). 
Superior Hypogastric Plexus Block (SHPB) 
After trocar placement, the promontory is exposed, the peritoneum tented, and a 1-
mm laparoscopic needle introduced. Ten milliliters of study solution (ropivacaine or 
saline) are injected into the presacral space. 
Postoperative Analgesia (Standardized for All Groups) 
 Ketorolac IV every 8 h (first 24 h), then q12h. 

 Paracetamol IV every 8 h (first 24 h), then q12h. 
 Rescue opioid: intramuscular promedol 1 mg when NRS >4. 
Pain scores and pain type are assessed at predetermined time points. Mobilization is 
attempted on the evening of surgery; mobilization time is recorded. 
Outcome Measures 
Primary Endpoint 
Pain intensity at 4 hours postoperatively (Numeric Rating Scale, NRS 0–10). 
Secondary Endpoints 
 NRS pain score at all remaining time points (2, 6, 8, 12, 24 h). 
 Time to mobilization. 
 Proportion of patients requiring opioid rescue. 
 Patient-reported pain character (visceral vs somatic). 
Study Procedures 
Baseline (Preoperative) 
 Informed consent. 
 Demographic and clinical data collection. 
Randomization and Intraoperative Phase 
 Allocation concealed until patient is in the OR. 
 Preparation of masked syringes. 
 Administration of wound infiltration and SHPB per protocol. 
Postoperative Assessments 
 NRS pain scores at 2, 4, 6, 8, 12, and 24 h. 
 Pain type questionnaire at 4 h. 
 Documentation of opioid use. 
 Recording mobilization time. 

Study Completion 
 Final assessment at discharge. 
 Verification of completeness of data. 
Study Instruments 
 Numeric Rating Scale (NRS): 0–10 score assessing pain intensity. 
 Pain Character Questionnaire: differentiates visceral (deep, “menstrual-
like”) vs somatic (superficial, “muscle strain-like”) pain. 
Ethical Considerations 
The study complies with: 
 ICH-GCP guidelines 
 Declaration of Helsinki (2000 revision) 
 National and institutional regulatory requirements 
Ethics Committee approval will be obtained prior to study initiation. 
All participants will sign written informed consent. Confidentiality is ensured by 
coded identifiers. Patient welfare takes precedence over scientific objectives. 
Sample Size and Statistical Analysis 
Sample Size 
Based on G*Power calculations assuming: 
 50% baseline incidence of significant postoperative pain 
 Expected difference of ~25% between groups 
 α = 0.05, power = 90% 
The required sample size is 198 patients (66 per group). 
Statistical Analysis 
Analysis will be performed using IBM SPSS 29.0. 

 Normality: Kolmogorov–Smirnov test 
 Nonparametric data: median (IQR) 
 Intergroup comparisons: Kruskal–Wallis test with Dunn's post-hoc analysis 
 Categorical variables: Pearson χ² or Fisher’s exact test 
 Pain dynamics: Friedman test for repeated measures 
 Significance threshold: p < 0.05 (two-sided) 
 
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