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Breast CancerPhase 3NCT02620371

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

A Phase 3 study testing modified pectoral block in people with Breast Cancer, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
modified pectoral block
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
Sep 2015to Mar 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • South Egypt Cancer Instuite

    Asyut, 171516

Other trials in Egypt

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
modified pectoral block
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • modified pectoral blockProcedure or surgery

    Also called pecs II block

    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.

Study groups in NCT02620371
Study groupRoleWhat they receive
(bupivacaine)Placebo comparator30 patients were given preoperative ultrasound guided, modified pectoral block (pecs II block) with local anesthetic(0.25% bupivacaine)
Receives: Procedure: modified pectoral block
(bupivacaine, ketamine)Active comparator30 patients were given preoperative ultrasound guided, modified pectoral block (pecs II block) with local anesthetic(0.25% bupivacaine plus ketamine 1 mg/kg) .
Receives: Procedure: modified pectoral block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total morphine consumption

    Total morphine consumption in mg in the first 48 hours postoperatively

    Measured: first 48 hours postoperatively

Secondary outcomes (2)
  1. first request of rescue analgesia

    first request of analgesia in hours in the first 48 hrs postoperative

    Measured: 48 hours postoperatively

  2. the severity of pain was assessed using VAS score

    he severity of pain was assessed using VAS score in 48 hours postoperative

    Measured: 48 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02620371
Sponsor's protocol ID
226
Status last verified
Sep 2015
First submitted
27 Nov 2015
Last updated
19 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27676665

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing modified pectoral block in people with Breast Cancer, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total morphine consumption (time frame: first 48 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02620371, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.

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