Overview

This trial is active, not recruiting.

Conditions acute pain, chronic pain
Treatment paravertebral block
Phase phase 1/phase 2
Sponsor Assiut University
Start date May 2015
End date December 2016
Trial size 90 participants
Trial identifier NCT02462681, 211

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
patients will be received 20 ml of bupivacaine 0.25% paravertebrally, divided into 3-4 ml in each level
paravertebral block ketamine hydrochloride
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 The needle will be withdrawn and walk cephalad off the transverse process and advance for a further 1.5 to 2 cm.
(Active Comparator)
patients will be received 20 ml of bupivacaine 0.25% + 0.5 mg/kg ketamine paravertebrally divide into 3-4 ml in each level
paravertebral block ketamine hydrochloride
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 The needle will be withdrawn and walk cephalad off the transverse process and advance for a further 1.5 to 2 cm.
(Active Comparator)
patients will be received 20 ml of bupivacaine 0.25% + 1mg/kg ketamine paravertebrally divide into 3-4 ml in each level
paravertebral block ketamine hydrochloride
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 Outcomes

Measure
changes in pain intensity score from baseline
time frame: at 2,4,6,12,24,36and 48 hour postoperatively

Secondary Outcomes

Measure
side effect
time frame: 2,4,6,12,24,36and 48 hour postoperatively.
chronic neuropathic pain
time frame: 1st,2nd and 3rd postoperative months

Eligibility Criteria

Female participants from 25 years up to 70 years old.

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

Additional Information

Official title Ketamine as Adjunctive Analgesic With Bupivacaine in Paravertebral Analgesia for Breast Cancer Surgery
Principal investigator Sahar A. Mohamed, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Assiut University.