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Efficacy of Ketamine Added to Local Anesthetic in Modified Pectoral Block for Management of Postoperative Pain

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
modified pectoral block
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) class I-II
  • Body weight of 50 - 90 kg

Exclusion Criteria:

  • History of bleeding diathesis
  • Relevant drug allergy, opioid dependence
  • Morbid obesity, sepsis
  • prior surgery in the supraclavicular, infraclavicular or axillary regions,
  • Alcohol or drug abuse
  • Those with psychiatric illnesses that would interfere with perception and assessment of pain

Sites / Locations

  • South Egypt Cancer Instuite

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

(bupivacaine)

(bupivacaine, ketamine)

Arm Description

30 patients were given preoperative ultrasound guided, modified pectoral block (pecs II block) with local anesthetic(0.25% bupivacaine)

30 patients were given preoperative ultrasound guided, modified pectoral block (pecs II block) with local anesthetic(0.25% bupivacaine plus ketamine 1 mg/kg) .

Outcomes

Primary Outcome Measures

Total morphine consumption
Total morphine consumption in mg in the first 48 hours postoperatively

Secondary Outcome Measures

first request of rescue analgesia
first request of analgesia in hours in the first 48 hrs postoperative
the severity of pain was assessed using VAS score
he severity of pain was assessed using VAS score in 48 hours postoperative

Full Information

First Posted
November 27, 2015
Last Updated
April 15, 2016
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02620371
Brief Title
Efficacy of Ketamine Added to Local Anesthetic in Modified Pectoral Block for Management of Postoperative Pain
Official Title
Efficacy and Safety of Ketamine Added to Local Anesthetic in Modified Pectoral Block for Management of Postoperative Pain in Patients Undergoing Modified Radical Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to compare the analgesic efficacy and safety of local bupivacaine alone versus bupivacaine plus ketamine in ultrasound guided modified Pecs block in patients undergoing breast cancer surgery.
Detailed Description
This randomized Clinical trial was approved by the ethics committee of South Egypt Cancer Institute, Assuit University, Assuit, Egypt. Sixty patients aged 18 - 60 years, American Society of Anesthesiologists (ASA) class I-II, with body weight of 50 - 90 kg and arranged for modified radical mastectomy) were enrolled in this study. Patients with a history of bleeding diathesis, relevant drug allergy, opioid dependence, morbid obesity, sepsis, prior surgery in the supraclavicular, infraclavicular or axillary regions, alcohol or drug abuse and those with psychiatric illnesses that would interfere with perception and assessment of pain were excluded from the study. Preoperatively, patients were taught how to evaluate their own pain intensity using the Visual Analog Scale (VAS), scored from 0-10 (where 0= no pain and 10=worst pain imaginable), and whenever (during the follow up period) VAS points to a value ≥ 3. Analgesia comprised PCA with an initial morphine bolus of 0.1mg/kg once pain expressed by the patient or if VAS ≥ 3 followed by 1mg boluses with a lockout period a 5 minute. The time to first request for analgesia and the total analgesic consumption in the first 24 hours were recorded. On arrival to the operating room, an intravenous line was inserted. Monitoring included electrocardiography (ECG), non-invasive blood pressure (NIBP), arterial oxygen saturation (Sao2) and end-tidal carbon- dioxide were applied. Anesthesia was induced for all participating patients with 2 μg/kg fentanyl, 2-3 mg/kg propofol and 1.5 mg/kg lidocaine. Endotracheal intubation was facilitated by 0.15 mg/kg cis-atracurium. Anesthesia was maintained by 1-1.5 MAC isoflurane in 50% oxygen / air mixture and 0.03 mg/kg cisatrcurium respectively in ventilation parameters to maintain on ETco2 of approximately 35- 40 mmHg. Ultrasound guided pecs block then performed Patients were randomly assigned into 2 groups (using a randomization-computer program), 30 patients in each: Group I (Bupivacaine group): patients were given ultrasound guided, modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the two pectoralis muscles on the interfascial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle. Group II (Bupivacaine + ketamine group) : patients were given ultrasound guided, modified Pecs block with 30 ml of 0.25% bupivacaine plus ketamine (1 mg/kg) divided into 10 ml injected between the two pectoralis muscles on the interfascial plane , and 20 ml injected between the Pectoralis minor muscle and the serratus muscle. Modified Pecs block was performed under general anesthesia, and 15 min. before skin incision. We performed the modified Pecs block or the " Pecs II block" by using a two needle approach instead of one. The first puncture is a Pecs I block with 10 ml of local anesthetic injected between the two pectoralis muscles, and the second puncture injects 20 ml of local anesthetic between the Pectoralis minor muscle and the serratus muscle. This breaks through the 'axillary door' and will reach the long thoracic nerve and reliably at least two intercostal nerves. We used a broadband linear array probe, with an imaging depth of 3-4cm. starting from the lateral third of the clavicle and moving distally and laterally to the mid axillary line. At the end of surgery, reversal of muscle relaxant was done using neostigmine (0.04 mg/kg) and atropine (0.01 mg/kg). After extubation; all patients were transmitted to post anesthesia care unit (PACU). Each patient in both groups was followed up and assessed at baseline, 1h, 2h, 4h, 6h , 12h , 24h, 48h postoperatively for: Vital signs (The patients' heart rate, non invasive arterial blood pressure, respiratory rate and oxygen saturation), Post operative pain where the severity of pain was assessed using VAS score, the time to first request of rescue analgesia and total morphine consumption in the 48 hours. Potential side effects, including, sedation by sedation score of 0-4 (0 = patient fully awake; 1 = patient somnolent and responsive to verbal commands; 2 = patient somnolent and responsive to tactile stimulation; and 3 = patient asleep and responsive to painful stimulation; 4 = not arousable), chest pain, nausea, vomiting (treated by IV boluses of metochlopromide 10 mg), and psychological complications (hallucination, delirium, dreams, nystagmus, dissociative effects) were also recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(bupivacaine)
Arm Type
Placebo Comparator
Arm Description
30 patients were given preoperative ultrasound guided, modified pectoral block (pecs II block) with local anesthetic(0.25% bupivacaine)
Arm Title
(bupivacaine, ketamine)
Arm Type
Active Comparator
Arm Description
30 patients were given preoperative ultrasound guided, modified pectoral block (pecs II block) with local anesthetic(0.25% bupivacaine plus ketamine 1 mg/kg) .
Intervention Type
Procedure
Intervention Name(s)
modified pectoral block
Other Intervention Name(s)
pecs II block
Intervention Description
Modified Pecs block was performed under general anesthesia, and 15 min. before skin incision. We performed the modified Pecs block or the " Pecs II block" by using a two needle approach instead of one. The first puncture is a Pecs I block with 10 ml of local anesthetic injected between the two pectoralis muscles, and the second puncture injects 20 ml of local anesthetic between the Pectoralis minor muscle and the serratus muscle. This breaks through the 'axillary door' and will reach the long thoracic nerve and reliably at least two intercostal nerves. We used A high frequency linear US probe is used for this block. a broadband linear array probe, with an imaging depth of 3-4cm. starting from the lateral third of the clavicle and moving distally and laterally to the mid axillary line.
Primary Outcome Measure Information:
Title
Total morphine consumption
Description
Total morphine consumption in mg in the first 48 hours postoperatively
Time Frame
first 48 hours postoperatively
Secondary Outcome Measure Information:
Title
first request of rescue analgesia
Description
first request of analgesia in hours in the first 48 hrs postoperative
Time Frame
48 hours postoperatively
Title
the severity of pain was assessed using VAS score
Description
he severity of pain was assessed using VAS score in 48 hours postoperative
Time Frame
48 hours postoperatively
Other Pre-specified Outcome Measures:
Title
Potential side effects
Description
Potential side effects, including, sedation by sedation score of 0-4 (0 = patient fully awake; 1 = patient somnolent and responsive to verbal commands; 2 = patient somnolent and responsive to tactile stimulation; and 3 = patient asleep and responsive to painful stimulation; 4 = not arousable), chest pain, nausea, vomiting (treated by IV boluses of metochlopromide 10 mg), and psychological complications (hallucination, delirium, dreams, nystagmus, dissociative effects)
Time Frame
48 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) class I-II Body weight of 50 - 90 kg Exclusion Criteria: History of bleeding diathesis Relevant drug allergy, opioid dependence Morbid obesity, sepsis prior surgery in the supraclavicular, infraclavicular or axillary regions, Alcohol or drug abuse Those with psychiatric illnesses that would interfere with perception and assessment of pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UNVERSITY
Organizational Affiliation
ASSUIT
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Egypt Cancer Instuite
City
Assuit
ZIP/Postal Code
171516
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
27676665
Citation
Othman AH, El-Rahman AM, El Sherif F. Efficacy and Safety of Ketamine Added to Local Anesthetic in Modified Pectoral Block for Management of Postoperative Pain in Patients Undergoing Modified Radical Mastectomy. Pain Physician. 2016 Sep-Oct;19(7):485-94.
Results Reference
derived

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Efficacy of Ketamine Added to Local Anesthetic in Modified Pectoral Block for Management of Postoperative Pain

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