Pre-incisional Wound INfiltration and Hypogastric PLEXus Block Using Ropivacaine in Laparoscopic Myomectomy

Browse trials for

• Leiomyoma 490
• Pain, Postoperative 5,093

Keywords

• Uterine fibroid
• Laparoscopic myomectomy
• Postoperative pain
• Pre-incisional infiltration
• Hypogastric plexus block
• EQ-5D questionnaire
• Picker questionnaire
• The Central Sensitization Inventory (CSI-R)

Leiomyoma

490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.

This study's enrollment of 207 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.

Lead sponsor

Saint Petersburg State University, Russia is the lead sponsor of 34 studies on the registry; 14 are open to participants now.

Study arms

• Placebo comparator
  Standart analgesia

  Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics).

  Procedure: Troacar site infiltration · Procedure: Superior hypogastric plexus block

• Active comparator
  Troacar site infiltration

  Troacar site infiltration without SHP block

  Procedure: Troacar site infiltration · Procedure: Superior hypogastric plexus block

• Experimental
  SHP block

  Standard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block

  Procedure: Troacar site infiltration · Procedure: Superior hypogastric plexus block

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.

Primary outcomes

1. 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

Secondary outcomes

1. 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

2. Mobilization

   Timing of post-surgery mobilization (hours after surgery)

   Time frame: Early postoperative period

3. Opioid Use

   Number of opioid administrations

   Time frame: Postoperative period, up to 48 hours

4. 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

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Apr 12, 2024

Documents are hosted by the registry — open the source record to download them.