NCT03302689

Brief Summary

Randomized, double-blind, controlled trial: a comparison of Levobupivacaine and Ropivacaine for postoperative analgesia using TAP-block Objectives:

  1. 1.VAS score during the first 12 hours
  2. 2.Determine which drug is more effective for postoperative analgesia in the first 12 hours after surgery
  3. 3.Side effects

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

September 25, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 26, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

28 days

First QC Date

September 26, 2017

Last Update Submit

October 24, 2017

Conditions

Pain, Postoperative

Keywords

TAP-blockVAS of painCesarean sectionPostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • Level of pain

    Measurement of pain on a VAS scale (from 0 to 10 points)

    12 hours

Secondary Outcomes (1)

  • The need for additional analgesics (Paracetamol, Tramadol)

    12 hours

Study Arms (2)

Ropivacaine

EXPERIMENTAL

TAP-block with Ropivacaine Solution

Drug: Ropivacaine Solution

Levobupivacaine

EXPERIMENTAL

TAP-block with Levobupivacaine Solution

Drug: Levobupivacaine Solution

Interventions

Levobupivacaine SolutionDRUG

TAP-block with Levobupivacaine 0,3% - 25 ml from each side

Also known as: Levo
Levobupivacaine
Ropivacaine SolutionDRUG

TAP-block with Ropivacaine 0,3% - 25 ml from each side

Also known as: Rop
Ropivacaine

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cesarean section pfannenstiel incision under spinal anesthesia
  • Spinal anesthesia with Bupivacaine heavy 0,5%
  • Without any adjuvants

You may not qualify if:

  • Any other anesthesia exept spinal
  • Any other surgical incision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tver Regional Perinatal Center

Tver', Russia

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Women after the operation do not know what drug they injected with TAP-block The researcher does not know what type of drug is injected
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups of women after cesarean section under spinal anesthesia
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of department of Anaesthesiology and Intensive Care Unit

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 5, 2017

Study Start

September 25, 2017

Primary Completion

October 23, 2017

Study Completion

January 1, 2018

Last Updated

October 25, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)