NCT05686382

Brief Summary

This no-profit, monocentric, prospective randomized controlled trial, aims to demonstrate the non-inferiority of continuous wound infusion (CWI) when compared to transversus abdominis plane (TAP) block for postoperative pain control after total abdominal hysterectomy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

January 4, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

January 2, 2023

Last Update Submit

January 13, 2023

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • opioid consumption

    morphine equivalents requested (patients request oxycodone 5 mg (7,5 mg morphine equivalents) each time they experience pain at intensity higher than 4 in the NRS scale

    Change from baseline and hours 6, 12, 24, 48

Secondary Outcomes (12)

  • postoperative pain at rest

    hours 6, 12, 24, 48

  • postoperative pain during movements

    hours 6, 12, 24, 48

  • Postoperative Nausea and Vomiting (PONV)

    hours 6, 12, 24, 48

  • early refeeding

    hours 3, 12, 24, 48

  • early mobilization SIT-STAND-WALK

    hours 3, 12, 24, 48

  • +7 more secondary outcomes

Study Arms (2)

group TAP block

ACTIVE COMPARATOR

TAP block is administered at the end of the surgery, bilaterally, with lateral approach, with 24 ml of 0,5% ropivacaine for each side

Procedure: TAP block

group CWI

EXPERIMENTAL

A 15 cm long, multihole catheter is placed on the preperitoneal plane before fascia closure; a starting bolus of 10 ml of 0,5% ropivacaine is administered through the catheter, then a continuous infusion of 0,2% ropivacaine at a rate of 5 ml/h is started through a pump and continued for 48 hours

Procedure: Continuous Wound Infusion

Interventions

Continuous Wound InfusionPROCEDURE

continuous local anesthetic infiltration of the wound

group CWI
TAP blockPROCEDURE

ultrasound guided injection of local anesthetic in the fascial plane between the internal oblique and transversus abdominis muscles

group TAP block

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I - III
  • laparotomic hysterectomy with Pfannenstiel incision
  • signed informed consent

You may not qualify if:

  • ASA IV
  • allergy to local anesthetics or other components of multimodal analgesia
  • inability to walk or eat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CampusBioMedico

Rome, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Fabio Costa, Dr.

    Fondazione Policlinico Universitario Campus Biomedico di Roma

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Costa, Dr.

CONTACT

3356526433f.costa@policlinicocampus.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Department of Anesthesia - Principal Investigator

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 17, 2023

Study Start

January 4, 2023

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

January 17, 2023

Record last verified: 2023-01

Locations

IT(1)