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Status unknownNCT03536741Updated May 25, 2018

Role of TAP and RS Block in Reduction of Postoperative Pain for Gynecological Surgical Laparoscopic Procedures

A Phase 2 interventional study of TAP block and RS block + General Intravenous Anesthestic and General Intravenous Anesthetic in TAP and RS Block, sponsored by Campus Bio-Medico University. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-05-25.

Sponsored by Campus Bio-Medico University · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2017, registered Mar 2018).
Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

The present study aims to demonstrate the effectiveness of loco-regional wall anesthesia of the transversus abdominis plane block (TAP block) and the rectus sheath block (RS block), compared to intravenous analgesia, in terms of pain reduction, postoperative analgesic drugs consumption, patient satisfaction and decrease of LOS (length of stay), in patients undergoing benign gynecological laparoscopic surgical procedures.

02

Conditions studied

  • TAP and RS Block

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.

This study's planned enrollment of 70 is close to the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Campus Bio-Medico University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • patients undergoing benign laparoscopic gynecological surgery
  • age between 18 and 75 years
  • BMI >18 e \<35
  • ECOG Performance Status 0-1

Exclusion criteria

Exclusion Criteria:

  • age \< 18 or > 75 years
  • BMI \<18 or > 35
  • ECOG Performance Status >1
  • Allergy to local anesthetics
  • Allergy to NSAIDs
  • Chronic kidney failure > II class
  • Systemic neoplastic disease actual or previous
  • Actual pregnancy
  • Active or recent pelvic inflammation
  • Persistent coagulopathy
  • Previous opioids consumption for chronic pain
  • Neurological or cognitive disorders
  • Conversion from laparoscopic to open surgery
  • Onset of intraoperative complications
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    ALR

    Procedure: TAP block and RS block + General Intravenous Anesthestic

  • Active comparator
    EV

    Drug: General Intravenous Anesthetic

Interventions

  • ProcedureTAP block and RS block + General Intravenous Anesthestic

    transversus abdominis plane block and rectus sheath block

  • DrugGeneral Intravenous Anesthetic

    General Intravenous Anesthetic

06

What researchers measure

Primary outcomes

  1. postoperative pain in the first 72 hours after gynecological surgical procedures

    postoperative pain in the first 72 hours after gynecological surgical procedures

    Time frame: postoperative pain in the first 72 hours after gynecological surgical procedures

  2. analgesic consumption in the first 72 hours after gynecological surgical procedures

    analgesic consumption in the first 72 hours after gynecological surgical procedures

    Time frame: analgesic consumption in the first 72 hours after gynecological surgical procedures

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03536741
Lead sponsor
Campus Bio-Medico University
Responsible party
Corrado Terranova (Principal Investigator, Campus Bio-Medico University) — Principal investigator
First posted
May 25, 2018
Start date
Oct 12, 2017
Primary completion
Jul 12, 2018 (estimated)
Completion
Jul 12, 2018 (estimated)
Last update
May 25, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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