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

NCT ID: NCT02462681

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-06-30

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.

Conditions

Acute Pain; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

bupivacaine group in paravertebral block

patients will be received 20 ml of bupivacaine 0.25% paravertebrally, divided into 3-4 ml in each level

Group Type: ACTIVE_COMPARATOR

paravertebral block

Intervention Type: DRUG

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.

bupivacaine + 0.5 mg/kg ketamine group in 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

Group Type: ACTIVE_COMPARATOR

paravertebral block

Intervention Type: DRUG

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.

bupivacaine + 1 mg/kg ketamine group in paravertebral block

patients will be received 20 ml of bupivacaine 0.25% + 1mg/kg ketamine paravertebrally divide into 3-4 ml in each level

Group Type: ACTIVE_COMPARATOR

paravertebral block

Intervention Type: DRUG

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.

Interventions

paravertebral block

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.

Intervention Type: DRUG

Other Intervention Names

ketamine hydrochloride

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shereen Mamdouh

lecturer of anesthesia,ICU and pain relief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sahar A. Mohamed, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of anesthesia, ICU and pain management- South Egypt Cancer Institute- Assuit University

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

Other Identifiers

211

Identifier Type: -

Identifier Source: org_study_id