Ketamine as Adjunctive Analgesic With Bupivacaine in Paravertebral Analgesia for Breast Cancer Surgery

Phase 1

Completed

• Conditions: Acute Pain; Chronic Pain
• Interventions: Drug: paravertebral block

• Registration Number: NCT02462681
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-30
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-04
• Primary Completion: 2016-12
• Status Verified: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-29
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
bupivacaine group in paravertebral block	paravertebral block	patients will be received 20 ml of bupivacaine 0.25% paravertebrally, divided into 3-4 ml in each level
bupivacaine + 0.5 mg/kg ketamine group in paravertebral block	paravertebral block	patients will be received 20 ml of bupivacaine 0.25% + 0.5 mg/kg ketamine paravertebrally divide into 3-4 ml in each level
bupivacaine + 1 mg/kg ketamine group in paravertebral block	paravertebral block	patients will be received 20 ml of bupivacaine 0.25% + 1mg/kg ketamine paravertebrally divide into 3-4 ml in each level

Primary Outcome Measures

Name	Time	Method
changes in pain intensity score from baseline	at 2,4,6,12,24,36and 48 hour postoperatively	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

Name	Time	Method
side effect	2,4,6,12,24,36and 48 hour postoperatively.	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	1st,2nd and 3rd postoperative months	(Douleur Neuropathique 4 questions) (DN4) questionnaire will be used for assessment of development of neuropathic pain

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt