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

Saint Petersburg State University, Russia

Status: Completed

Conditions: Fibroid Uterus; Pain, Postoperative

Treatments: Procedure: Troacar site infiltration; Procedure: Superior hypogastric plexus block

Study type: Interventional

Funder types: Other

Identifiers

NCT06429163

WINPLEX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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207 participants in 3 patient groups, including a placebo group

Standart analgesia

Placebo Comparator group

Description:

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

Treatment:

Procedure: Superior hypogastric plexus block

Procedure: Troacar site infiltration

Troacar site infiltration

Active Comparator group

Description:

Troacar site infiltration without SHP block

Treatment:

Procedure: Superior hypogastric plexus block

Procedure: Troacar site infiltration

SHP block

Experimental group

Description:

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

Treatment:

Procedure: Superior hypogastric plexus block

Procedure: Troacar site infiltration