NCT02671851

Brief Summary

Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative analgesia in mastectomy, thoracic and video-assisted thoracic surgeries. Objective: To assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA) could postpone time to first pain and improve postoperative analgesia in patients undergoing bilateral reduction mammoplasty. Design: A historical cohort study. Patients: Of the 70 female patients who underwent bilateral reduction mammoplasty, 64 patients had complete data in the acute pain/regional anaesthesia database. Intervention: Thirty patients, received only GA, were included in Group GA. Thirty-four patients, received bilateral single injection ultrasound-guided TPVBs with 20 mL bupivacaine 0.375% as an adjunct to GA, were included in Group TPVBs. Patients in both groups were administered intraoperative fentanyl if heart rate or mean arterial pressure increased \>20% above pre-induction values, postoperative tramadol 1mg/kg in the postoperative care unit (PACU) if numeric rating scale (NRS) was ≥4, and rescue analgesics as metamizole sodium 4x1g and/or paracetamol 3x1g on wards (NRS≥4). Main outcome measures: The primary endpoint was time to first pain after the surgery. Secondary endpoints were intra- and postoperative opioid and other rescue analgesic requirements, length of stay in the PACU, pain scores, incidence of postoperative nausea and vomiting (PONV), and patient and surgeon satisfaction through the postoperative first 2 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

January 22, 2016

Last Update Submit

February 9, 2016

Conditions

Pain, Postoperative

Keywords

Thoracic Paravertebral BlocksUltrasound GuidanceReduction MammoplastyTime to First PainPostoperative Analgesia

Outcome Measures

Primary Outcomes (1)

  • Time to first pain

    Postoperative first pain description NRS ≥4

    0-48 hours

Secondary Outcomes (8)

  • Fentanyl use

    During the surgery

  • Tramadol use

    0-2 hours

  • Rescue analgesic requirement

    0-48 hours

  • Length of stay in the PACU

    0-2 hours

  • Pain (NRS) scores

    0-48 hours

  • +3 more secondary outcomes

Study Arms (2)

Thoracic paravertebral blocks (TPVBs)

Patients received bilateral single injection ultrasound-guided TPVBs at the level of T3-T4 with 20 mL bupivacaine 0.375% as an adjunct to general anaesthesia. IV metamizole sodium and paracetamol were rescue analgesics.

Drug: Thoracic paravertebral blocks (TPVBs)

IV metamizole sodium, paracetamol

Patients received only standardized general anaesthesia. IV metamizole sodium and paracetamol were rescue analgesics.

Drug: IV metamizole sodium, paracetamol

Interventions

Thoracic paravertebral blocks (TPVBs)DRUG

Patients received bilateral single injection ultrasound-guided TPVBs with 20mL bupivacaine 0.375% at the level of T3-T4 as an adjunct to GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used.

Also known as: Bupivacaine,fentanyl,tramadol,metamizole sodium,paracetamol
Thoracic paravertebral blocks (TPVBs)
IV metamizole sodium, paracetamolDRUG

Patients received only standardized GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used.

Also known as: Fentanyl,tramadol,metamizole sodium,paracetamol
IV metamizole sodium, paracetamol

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients undergoing bilateral reduction mammoplasty

You may qualify if:

  • ASA I-III patients who underwent bilateral reduction mammoplasty

You may not qualify if:

  • Patients with deficient data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Department of Anaesthesiology

Istanbul, Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (5)

  • Kaya FN, Turker G, Mogol EB, Bayraktar S. Thoracic paravertebral block for video-assisted thoracoscopic surgery: single injection versus multiple injections. J Cardiothorac Vasc Anesth. 2012 Feb;26(1):90-4. doi: 10.1053/j.jvca.2011.09.008. Epub 2011 Nov 4.

    PMID: 22055006RESULT

  • Kaya FN, Turker G, Basagan-Mogol E, Goren S, Bayram S, Gebitekin C. Preoperative multiple-injection thoracic paravertebral blocks reduce postoperative pain and analgesic requirements after video-assisted thoracic surgery. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):639-43. doi: 10.1053/j.jvca.2006.03.022. Epub 2006 Aug 8.

    PMID: 17023279RESULT

  • Moller JF, Nikolajsen L, Rodt SA, Ronning H, Carlsson PS. Thoracic paravertebral block for breast cancer surgery: a randomized double-blind study. Anesth Analg. 2007 Dec;105(6):1848-51, table of contents. doi: 10.1213/01.ane.0000286135.21333.fd.

    PMID: 18042892RESULT

  • Terheggen MA, Wille F, Borel Rinkes IH, Ionescu TI, Knape JT. Paravertebral blockade for minor breast surgery. Anesth Analg. 2002 Feb;94(2):355-9, table of contents. doi: 10.1097/00000539-200202000-00023.

    PMID: 11812698RESULT

  • Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.

    PMID: 10825328RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineDipyroneAcetaminophenFentanyl

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAminopyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesPiperidines

Study Officials

  • Emine A Salviz, MD

    Design and conduct the study, review and analyze the data, and write the manuscript

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Attending Anesthesiologist

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 2, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 10, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)