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Comparing Effect of Adding Ketamine Versus Dexmedetomidine to Bupivacaine in Pec 11 Modified Block on Postoperative Pain Control in Patients Undergoing Breast Surgery

Primary Purpose

More Effective Postoperative Analgesia After Modified Radical Mastectomy With Better Drug Combination, More Prolonged Duration of Postoperative Analgesia After Modified Radical Mastectomy With Better Drug Combination

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Modified pec11 trunk block
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for More Effective Postoperative Analgesia After Modified Radical Mastectomy With Better Drug Combination

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patients ASA1,11,111 between 18 and 60 years scheduled for modified radical mastectomy

Exclusion Criteria:

  • Patients with history of advanced cardiac disease
  • Patients having sepsis,
  • Patients with prior surgery in areas above or below the clavicle or in the axillary region,
  • Patients with opioid dependence or alcohol or drug abuse,
  • Patients with coagulopathy
  • Patients with psychiatric illness that prevent them from proper perception and assessment of pain.

Sites / Locations

  • Ain Shams university Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Modified pec 11 trunk block using ketamine additive

Modified pec 11trunk block using dexmedetomidine additive

Modified pec 11trunk block without additive

Arm Description

Ultasound guided modified pec 11 trunk block using ketamie hydrochoride 1mg/kg in 2ml volume added to 30ml bupivacaine 0.25% for trunk analgesia

Ultasound guided modified pec 11 trunk block using dexmedetomidine 1ug/kg in 2ml volume added to 30ml bupivacaine 0.25%

Ultasound guided modified pec 11 trunk block using bupivacaine 0.25% added to 2ml saline

Outcomes

Primary Outcome Measures

Total postoperative morphine consumption over the first 24 hours postoperative
number value
The time to first request of analgesic postoperatively
time

Secondary Outcome Measures

pain scores at rest and active movement of ipsilateral arm
number value
intraoperative fentanyl requirements
number value

Full Information

First Posted
May 6, 2020
Last Updated
May 6, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04380168
Brief Title
Comparing Effect of Adding Ketamine Versus Dexmedetomidine to Bupivacaine in Pec 11 Modified Block on Postoperative Pain Control in Patients Undergoing Breast Surgery
Official Title
Comparing Effect of Adding Ketamine Versus Dexmedetomidine to Bupivacaine in Pec 11 Modified Block on Postoperative Pain Control in Patients Undergoing Breast Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
in our study we are trying to reach to the preferred adjuvant from either ketamine or dexmedetomidine to be added to bupivacaine local anesthetic during pec 11 modified block as regard its efficacy and duration of postoperative analgesia it can maintain after modified radical mastectomy surgery so as to achieve better control of postoperative pain than using local anesthetic alone.
Detailed Description
Type of Study: Randomized controlled trials Study Setting: Operating theater of Ain Shams University Hospitals, Cairo, Egypt Study Period: 6 months . Sampling Method: Patients will be subdivided randomly into 3 groups : Group (PC): will receive 30 ml of 0.25%bupivacaine plus 2ml normal saline. Group (PK): will receive 30 ml of 0.25% bupivacaine added to ketamine hydrochloride 1mg/kg diluted in 2ml normal saline. Group(PD): will receive 30 ml of 0.25%bupivacaine added to dexmedetomidine 1ug/kg diluted in 2 ml normal saline. Study Procedure Following local university ethical committee approval, informed consent will be obtained. Details of the anesthetic technique and the study protocol will be fully explained at the preoperative visit, and written consent will be obtained from each patient before inclusion in the study. In the pre-induction room the patients will be taught how to assess their own pain score using the numerical rating scale (NRS) (0-10; 0 = no pain, 10 = worst imaginable pain) and how to use the device for a patient-controlled analgesia (PCA) .Patients in all groups will receive 5mg oral midazolam ,2 hours prior to surgery.A20 gauge IV cannula will be inserted in the upper limb contralateral to the side of surgery upon reaching the operating room .Before induction of anesthesia electrocardiography (ECG), non-invasive blood pressure (NIBP), arterial oxygen saturation (Sao2), and end-tidal carbon dioxide (EtCo2) will connected to the patient. In all groups general anaesthesia will be induced using 2 μg/kg fentanyl, 2.5mg/kg propofol and 1 mg/kg lidocaine. Endotracheal intubation will be facilitated by 0.5 atracurium and was maintained by 1 MAC sevoflurane in 50% Oxygen /air mixture, and ventilator parameters will be adjusted to maintain normocapnia. The Pecs11 Modified block will be done using in plane approach, an 80 mm needle using linear array ultrasound probe of high frequency (12Hz). The modified Pec 11 block will be done using two needle approach, an 80 mm needle(PajunkR SonoPlex Stim cannula U.S.A) with the aid of linear array ultrasound probe of high frequency (SonositeR, Inc. U.S.A). The modified Pec 11 block technique: The ultrasound probe will be angled inferolateral from the midclavicular level sagittal plane (same as in infraclavicular brachial plexus block) the axillary artery and veins are located ,then the probe will be moved laterally until the pectoralis minor and serratus anterior muscles are seen, after locating 2nd rib immediately under the axillary artery then the ultrasound probe will move caudally from this position until both the third and fourth ribs are seen , the probe is rotated 90 degrees so that it lies transversally and will move laterally toward the anterior axillary line keeping the third rib at the center so that the lateral border of pectoralis minor is will be identified and at the top of the third rib the serratus anterior muscle will be seen deeper to the pectoralis minor ,the needle then will be advanced from the medial to lateral side parallel to the ultrasound beam and 32ml of the solution will be injected between the pectoralis minor and serratus anterior muscles (8,9). For each group, the 32ml solution constituents are different, for PC group (the control group) the 32ml solution contain only 0.25% bupivacaine while for group PK it contains 1mg/kg ketamine hydrochloride in addition to bupivacaine ,while for group PD it contains 1ug/kg dexmetomedine in addition to bupivacaine. Surgery started 30 minutes after the block has been given. Fentanyl 0.5ug was given as a bolus if HR or BP rose 20% above the baseline values, Bradycardia (HR<50/minute) is treated with atropine 0.5mg bolus, and hypotension (20% below the baseline values) is treated with 10mg boluses of ephedrine. Patients were extubated after adequate neuromuscular reversal using atropine 0.02mg/kg and 0.05mg/kg neostigmine. After that the patients were transferred to post-anaesthesia care unit where they were followed up and assessed for the following parameters: O2 saturation(spo2),Respiratory rate(RR), Non-invasive blood pressure(NIBP),Heart rate(HR), and Sedation agitation scores using Richmond Agitation Sedation Scale(RASS)( +4=combative +3=very agitated +2=agitated +1=restless 0=alert and calm,-1=drowsy,-2=light sedation,-3=moderate sedation ,-4=deepsedation,-5=unarousable sedation) (11) will be measured 5, 10, 20, 30, 45, and 60 min postoperatively . Episodes of postoperative nausea and vomiting, sedation scale above 2,any psychological complications (as hallucinations, dreams),are recorded and treated. nausea and vomiting will be treated by ondansetron 4mg IV, if sedation scale scores< -2 patient will receive flumazenil 0.15mg IV over 15secnds ,and if patient manifest hallucination or RASS >+1, 1mg Midazolam IV will be given. Pain scores(NRS) at rest and movement of ipsilateral arm will be recorded every hour for 24 hour postoperatively .Total intraoperative fentanyl consumption ,and total postoperative morphine consumption for the first 24 hours postoperative will be calculated and the time of the first request of analgesic will be recorded. When analgesia is requested postoperatively( once the pain is expressed by the patient or the NRS was>3 ) an initial morphine bolus of 0.1mg/kg followed by 1mg bolus with a lockout periods of 15 minutes with no background infusion allowed. At the end of 24 h, the patient's satisfaction about the post-operative analgesia which was rated on a three-point scale, i.e., good = most satisfied, average = somewhat satisfied, poor= dissatisfied, will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
More Effective Postoperative Analgesia After Modified Radical Mastectomy With Better Drug Combination, More Prolonged Duration of Postoperative Analgesia After Modified Radical Mastectomy With Better Drug Combination

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified pec 11 trunk block using ketamine additive
Arm Type
Active Comparator
Arm Description
Ultasound guided modified pec 11 trunk block using ketamie hydrochoride 1mg/kg in 2ml volume added to 30ml bupivacaine 0.25% for trunk analgesia
Arm Title
Modified pec 11trunk block using dexmedetomidine additive
Arm Type
Active Comparator
Arm Description
Ultasound guided modified pec 11 trunk block using dexmedetomidine 1ug/kg in 2ml volume added to 30ml bupivacaine 0.25%
Arm Title
Modified pec 11trunk block without additive
Arm Type
Active Comparator
Arm Description
Ultasound guided modified pec 11 trunk block using bupivacaine 0.25% added to 2ml saline
Intervention Type
Procedure
Intervention Name(s)
Modified pec11 trunk block
Intervention Description
Ultrasound guided modified pec 11 block injecting local anesthetic with or without adjuvant between pectoralis minor and serratus anterior muscles
Primary Outcome Measure Information:
Title
Total postoperative morphine consumption over the first 24 hours postoperative
Description
number value
Time Frame
"through study completion ,an average of one year"
Title
The time to first request of analgesic postoperatively
Description
time
Time Frame
"through study completion ,an average of one year"
Secondary Outcome Measure Information:
Title
pain scores at rest and active movement of ipsilateral arm
Description
number value
Time Frame
"through study completion ,an average of one year"
Title
intraoperative fentanyl requirements
Description
number value
Time Frame
"through study completion ,an average of one year"

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients ASA1,11,111 between 18 and 60 years scheduled for modified radical mastectomy Exclusion Criteria: Patients with history of advanced cardiac disease Patients having sepsis, Patients with prior surgery in areas above or below the clavicle or in the axillary region, Patients with opioid dependence or alcohol or drug abuse, Patients with coagulopathy Patients with psychiatric illness that prevent them from proper perception and assessment of pain.
Facility Information:
Facility Name
Ain Shams university Hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Comparing Effect of Adding Ketamine Versus Dexmedetomidine to Bupivacaine in Pec 11 Modified Block on Postoperative Pain Control in Patients Undergoing Breast Surgery

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