NCT02620371

Brief Summary

This study aims to compare the analgesic efficacy and safety of local bupivacaine alone versus bupivacaine plus ketamine in ultrasound guided modified Pecs block in patients undergoing breast cancer surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_3 breast-cancer

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

September 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 19, 2016

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

November 27, 2015

Last Update Submit

April 15, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption

    Total morphine consumption in mg in the first 48 hours postoperatively

    first 48 hours postoperatively

Secondary Outcomes (2)

  • first request of rescue analgesia

    48 hours postoperatively

  • the severity of pain was assessed using VAS score

    48 hours postoperatively

Other Outcomes (1)

  • Potential side effects

    48 hours postoperatively

Study Arms (2)

(bupivacaine)

PLACEBO COMPARATOR

30 patients were given preoperative ultrasound guided, modified pectoral block (pecs II block) with local anesthetic(0.25% bupivacaine)

Procedure: modified pectoral block

(bupivacaine, ketamine)

ACTIVE COMPARATOR

30 patients were given preoperative ultrasound guided, modified pectoral block (pecs II block) with local anesthetic(0.25% bupivacaine plus ketamine 1 mg/kg) .

Procedure: modified pectoral block

Interventions

modified pectoral blockPROCEDURE

Modified Pecs block was performed under general anesthesia, and 15 min. before skin incision. We performed the modified Pecs block or the " Pecs II block" by using a two needle approach instead of one. The first puncture is a Pecs I block with 10 ml of local anesthetic injected between the two pectoralis muscles, and the second puncture injects 20 ml of local anesthetic between the Pectoralis minor muscle and the serratus muscle. This breaks through the 'axillary door' and will reach the long thoracic nerve and reliably at least two intercostal nerves. We used A high frequency linear US probe is used for this block. a broadband linear array probe, with an imaging depth of 3-4cm. starting from the lateral third of the clavicle and moving distally and laterally to the mid axillary line.

Also known as: pecs II block
(bupivacaine)(bupivacaine, ketamine)

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) class I-II
  • Body weight of 50 - 90 kg

You may not qualify if:

  • History of bleeding diathesis
  • Relevant drug allergy, opioid dependence
  • Morbid obesity, sepsis
  • prior surgery in the supraclavicular, infraclavicular or axillary regions,
  • Alcohol or drug abuse
  • Those with psychiatric illnesses that would interfere with perception and assessment of pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt Cancer Instuite

Asyut, 171516, Egypt

Location

Related Publications (1)

  • Othman AH, El-Rahman AM, El Sherif F. Efficacy and Safety of Ketamine Added to Local Anesthetic in Modified Pectoral Block for Management of Postoperative Pain in Patients Undergoing Modified Radical Mastectomy. Pain Physician. 2016 Sep-Oct;19(7):485-94.

    PMID: 27676665DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • UNVERSITY

    ASSUIT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 27, 2015

First Posted

December 3, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 19, 2016

Record last verified: 2015-09

Locations

EG(1)