Ketamine as Adjunctive Analgesic With Bupivacaine in Paravertebral Analgesia for Breast Cancer Surgery
Primary Purpose
Acute Pain, Chronic Pain
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
paravertebral block
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring ketamine, adjuvant, paravertebral block
Eligibility Criteria
Inclusion Criteria:
- all patients scheduled for elective modified radical mastectomy with axillary dissection will be enrolled in the study
Exclusion Criteria:
- patients with a known allergy to the study drugs
- patients with bleeding diathesis
- patients with infection at the site of injection
- patients with central neuropathy
- patients with liver impairment
- patients with renal impairment
- drugs or alcohol abusers
- patients with psychiatric illnesses
Sites / Locations
- Assiut University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
bupivacaine group in paravertebral block
bupivacaine + 0.5 mg/kg ketamine group in paravertebral block
bupivacaine + 1 mg/kg ketamine group in paravertebral block
Arm Description
patients will be received 20 ml of bupivacaine 0.25% paravertebrally, divided into 3-4 ml in each level
patients will be received 20 ml of bupivacaine 0.25% + 0.5 mg/kg ketamine paravertebrally divide into 3-4 ml in each level
patients will be received 20 ml of bupivacaine 0.25% + 1mg/kg ketamine paravertebrally divide into 3-4 ml in each level
Outcomes
Primary Outcome Measures
changes in pain intensity score from baseline
Visual analogue scale (VAS) Scored from 0-10 (where 0= no pain and 10= the worst pain imaginable) as it measured as VAS at rest (VAS.R) and during movement or ipsilateral arm abduction (VAS.M)
Secondary Outcome Measures
side effect
nausea, vomiting, hypotension, bradycardia, sedation, dizziness and nystagmus will recorded and treated also postoperative complications of the block such as accidental pneumothorax and vascular puncture will be recorded and treated
chronic neuropathic pain
(Douleur Neuropathique 4 questions) (DN4) questionnaire will be used for assessment of development of neuropathic pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02462681
Brief Title
Ketamine as Adjunctive Analgesic With Bupivacaine in Paravertebral Analgesia for Breast Cancer Surgery
Official Title
Ketamine as Adjunctive Analgesic With Bupivacaine in Paravertebral Analgesia for Breast Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to investigate the safety and the analgesic efficacy of adding Ketamine to bupivacaine 0.25% in thoracic PVB in patients undergoing modified radical mastectomy.
Detailed Description
Breast cancer is perhaps the most common cancer in women that requires frequent surgical intervention. Nearly 40% of post-operative breast surgery patients experience significant acute post-operative pain, with a pain score above five reflecting inadequacy of conventional pain management. Most of the responses of the human body to post-surgical pain have been proven to be detrimental to the patient's homeostasis and recovery. Moreover, the incidence of chronic postoperative pain in breast surgery patients is as high as 50% and inadequate analgesia is considered as an independent risk factor. Hence, a number of therapeutic measures have been accepted as a part of the "multi-modal" approach to post-operative pain control. Thoracic Paravertebral Block (PVB) is used for pain relief after thoracotomy , and mastectomy. PVB can provide profound, long lasting sensory differentiation. The resulting greater attenuation of surgical stress response may translate into reduced inotropic stimulation of the heart. Additionally, unlike general anesthesia, PVB can provide superior postoperative analgesia, less nausea and vomiting, shorter recovery time; require fewer analgesic, earlier mobilization, and earlier home readiness for discharge. The use of PVB in patients undergoing ambulatory breast surgery has cost-saving potential. There is little systematic research on the efficacy and tolerability of the addition of adjunctive analgesic agent in paravertebral analgesia. The addition of adjunctive analgesics, such as fentanyl and clonidine to local anesthetics has been shown to enhance the quality and duration of sensory neural blockade, and decrease the dose of local anesthetic and supplemental analgesia .
Ketamine is an anaesthetic agent with potent analgesic properties. Its mode of action includes noncompetitive antagonism at N-methyl d-aspartate (NMDA) receptors and a local anaesthetic effect. ketamine has been extensively used through epidural and caudal routes with variable results.It possesses some definite advantages over the conventional local anaesthetic agents as it stimulates cardiovascular system and respiratory system.The advantages of ketamine include a good analgesic effect, cardio vascular stability in a hypotensive state, bronchodilatation in asthmatics, and the absence of awareness. Disadvantages include increased heart rate and blood pressure, emergence phenomenon, laryngospasm and apnea, increases in intracranial and intraocular pressure, and the lack of visceral anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Chronic Pain
Keywords
ketamine, adjuvant, paravertebral block
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bupivacaine group in paravertebral block
Arm Type
Active Comparator
Arm Description
patients will be received 20 ml of bupivacaine 0.25% paravertebrally, divided into 3-4 ml in each level
Arm Title
bupivacaine + 0.5 mg/kg ketamine group in paravertebral block
Arm Type
Active Comparator
Arm Description
patients will be received 20 ml of bupivacaine 0.25% + 0.5 mg/kg ketamine paravertebrally divide into 3-4 ml in each level
Arm Title
bupivacaine + 1 mg/kg ketamine group in paravertebral block
Arm Type
Active Comparator
Arm Description
patients will be received 20 ml of bupivacaine 0.25% + 1mg/kg ketamine paravertebrally divide into 3-4 ml in each level
Intervention Type
Drug
Intervention Name(s)
paravertebral block
Other Intervention Name(s)
ketamine hydrochloride
Intervention Description
Thoracic paravertebral blocks will be performed as described by Moore and Katz. Intradermal lidocaine will be used at the site of the needle insertion. The superior aspect of the spinous processes of T1- T6 will be marked. The skin entry points will 3 cm laterals to the marks. A 22- gauge quincke spinal needle attach to extension tubing to a syringe containing study drugs will be used. The needle will be inserted perpendicular to the skin for a distance of 2 to 4 cm until the transverse process will contact. The needle will be withdrawn and walk cephalad off the transverse process and advance for a further 1.5 to 2 cm.
Primary Outcome Measure Information:
Title
changes in pain intensity score from baseline
Description
Visual analogue scale (VAS) Scored from 0-10 (where 0= no pain and 10= the worst pain imaginable) as it measured as VAS at rest (VAS.R) and during movement or ipsilateral arm abduction (VAS.M)
Time Frame
at 2,4,6,12,24,36and 48 hour postoperatively
Secondary Outcome Measure Information:
Title
side effect
Description
nausea, vomiting, hypotension, bradycardia, sedation, dizziness and nystagmus will recorded and treated also postoperative complications of the block such as accidental pneumothorax and vascular puncture will be recorded and treated
Time Frame
2,4,6,12,24,36and 48 hour postoperatively.
Title
chronic neuropathic pain
Description
(Douleur Neuropathique 4 questions) (DN4) questionnaire will be used for assessment of development of neuropathic pain
Time Frame
1st,2nd and 3rd postoperative months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients scheduled for elective modified radical mastectomy with axillary dissection will be enrolled in the study
Exclusion Criteria:
patients with a known allergy to the study drugs
patients with bleeding diathesis
patients with infection at the site of injection
patients with central neuropathy
patients with liver impairment
patients with renal impairment
drugs or alcohol abusers
patients with psychiatric illnesses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar A. Mohamed, MD
Organizational Affiliation
Lecturer of anesthesia, ICU and pain management- South Egypt Cancer Institute- Assuit University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
171516
Country
Egypt
12. IPD Sharing Statement
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Ketamine as Adjunctive Analgesic With Bupivacaine in Paravertebral Analgesia for Breast Cancer Surgery
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