Breast CancerNCT02625506
Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block
A study testing Levobupivacaine and Levobupivacaine and Tramadol in people with Breast Cancer and Radical Mastectomy Surgery, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the addition of tramadol combined with levobupivacaine in the reduction of postoperative pain, postoperative opioid consumption after modified radical mastectomy surgery. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Breast Cancer, Radical Mastectomy Surgery
- What is being tested?
- Levobupivacaine and Levobupivacaine and Tramadol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2012to 1 Jan 2016
- Phase
- Interventional
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status I or II.
- Patients scheduled for radical mastectomy surgery.
Who cannot join
- Severe or uncompensated cardiovascular diseases
- renal diseases
- Hepatic diseases
- Endocrinal diseases.
- Pregnancy
- Postpartum
Show all 14Show fewer
- Lactating females
- Allergy to study medications.
- Local skin infection
- Bleeding disorder
- Coagulation abnormality
- Spine deformity
- chest deformity
- Psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Adding Tramadol as Adjunctive Analgesic With Levobupivacaine in Modified Pectoral Nerve Block for Modified Radical Mastectomy Surgery
The aim of this study is to evaluate the addition of tramadol combined with levobupivacaine in the reduction of postoperative pain, postoperative opioid consumption after modified radical mastectomy surgery.
Read the detailed description
Breast surgeries are usually associated with sever postoperative pain ,good perioperative analgesic technique after breast surgery is always questionable Thoracic epidural and paravertebral blocks became the gold standard techniques for pain relief, however they may be associated with complications such as spinal cord injury, total spinal anesthesia ,inadvertent intravascular injection and pneumothorax.
Pecs block is less invasive procedure involving ultrasound guided inter-fascial injections which has been suggested as potential alternative analgesic technique.
The block produces excellent analgesia and can be used as a rescue block in cases where the analgesia provided by the paravertebral or epidural was patchy or ineffective .
Different drugs, including opioids, non-steroidal anti-inflammatory drugs, ketamine, clonidine, and neostigmine, have been added to local anesthetics to improve the duration and quality of analgesia.Tramadol has also been used for pain management of patients.
The power of this clinical trial was prospectively calculated using the G Power analysis program. Using a priory power analysis with accuracy mode calculations with visual analogue score (VAS) as the primary variant and assuming type I error protection of 0.05 and an effect size convention of 0.9, a total sample size of 54 patients (27 patients in each group) produced a power of 0.90. To protect against drop out cases we added 6 cases to the total number (total of 60 cases)
- Conditions
- Breast Cancer, Radical Mastectomy Surgery
- Being tested
- Levobupivacaine, Levobupivacaine and Tramadol
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine
Levobupivacaine and TramadolDrug
Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine in conjunction with tramadol
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine | Placebo comparator | Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine Receives: Drug: Levobupivacaine |
| Levobupivacaine and Tramadol | Active comparator | Patients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine and tramadol Receives: Drug: Levobupivacaine and Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain will be assessed by utilizing visual analogue scale (VAS)
Measured: For the first 24 hours after surgery
Secondary outcomes (6)
Changes in heart rate
Measured: For one hour after surgery
Changes in blood pressure
Measured: For one hour after surgery
Changes in peripheral oxygen saturation
Measured: For one hour after surgery
Changes in end-tidal carbon dioxide tension
Measured: For one hour after surgery
Time for first analgesic request from extubation
Measured: for 24 hours after surgery
Total analgesics received for 24 hrs after surgery
Measured: for 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study start1 Jun 2012
- Primary completion1 Dec 2015
- Study completion1 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salwa MS Hayes, MD, Principal investigator, Assistant Professor of Anesthesia and Surgical Intensive CareReem A Sharkawy, MD, Study director, Lecture of Anesthesia and Surgical Intensive CareTamer EM Farahat, MD, Study chair, Lecture of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625506
- Sponsor's protocol ID
- R/15.05.67
- Status last verified
- Sep 2020
- First submitted
- 21 Nov 2015
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Tramadol as Adjunctive Analgesic With Levobupivacaine in Modified Pectoral Nerve Block for Modified Radical Mastectomy Surgery
- ClinicalTrials.gov ID
- NCT02625506
- Acronym / sponsor ID
- R/15.05.67
- Conditions
- Breast Cancer, Radical Mastectomy Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the addition of tramadol combined with levobupivacaine in the reduction of postoperative pain, postoperative opioid consumption after modified radical mastectomy surgery.
Detailed description
Breast surgeries are usually associated with sever postoperative pain ,good perioperative analgesic technique after breast surgery is always questionable Thoracic epidural and paravertebral blocks became the gold standard techniques for pain relief, however they may be associated with complications such as spinal cord injury, total spinal anesthesia ,inadvertent intravascular injection and pneumothorax.
Pecs block is less invasive procedure involving ultrasound guided inter-fascial injections which has been suggested as potential alternative analgesic technique.
The block produces excellent analgesia and can be used as a rescue block in cases where the analgesia provided by the paravertebral or epidural was patchy or ineffective .
Different drugs, including opioids, non-steroidal anti-inflammatory drugs, ketamine, clonidine, and neostigmine, have been added to local anesthetics to improve the duration and quality of analgesia.Tramadol has also been used for pain management of patients.
The power of this clinical trial was prospectively calculated using the G Power analysis program. Using a priory power analysis with accuracy mode calculations with visual analogue score (VAS) as the primary variant and assuming type I error protection of 0.05 and an effect size convention of 0.9, a total sample size of 54 patients (27 patients in each group) produced a power of 0.90. To protect against drop out cases we added 6 cases to the total number (total of 60 cases)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine | Placebo comparator | Drug: LevobupivacainePatients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine |
| Levobupivacaine and Tramadol | Active comparator | Drug: Levobupivacaine and TramadolPatients will be subjected for radical mastectomy surgery and pectoral nerve block with levobupivacaine and tramadol |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I or II.
- Patients scheduled for radical mastectomy surgery.
Key exclusion criteria (14 listed)
- Severe or uncompensated cardiovascular diseases
- renal diseases
- Hepatic diseases
- Endocrinal diseases.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevobupivacaineUltrasound guided Pecs block will be performed using 20 ml of levobupivacaine | Drug | Levobupivacaine |
| Levobupivacaine and TramadolUltrasound guided Pecs block will be performed using 20 ml of levobupivacaine in conjunction with tramadol | Drug | Levobupivacaine and Tramadol |
Primary outcome
Postoperative pain
Time frame: For the first 24 hours after surgery
Postoperative pain will be assessed by utilizing visual analogue scale (VAS)
6 secondary outcomes
Changes in heart rate
Time frame: For one hour after surgery
Changes in blood pressure
Time frame: For one hour after surgery
Changes in peripheral oxygen saturation
Time frame: For one hour after surgery
Changes in end-tidal carbon dioxide tension
Time frame: For one hour after surgery
Time for first analgesic request from extubation
Time frame: for 24 hours after surgery
Total analgesics received for 24 hrs after surgery
Time frame: for 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salwa MS Hayes, MD principal investigator
Assistant Professor of Anesthesia and Surgical Intensive Care
Reem A Sharkawy, MD study director
Lecture of Anesthesia and Surgical Intensive Care
Tamer EM Farahat, MD study chair
Lecture of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levobupivacaine and Levobupivacaine and Tramadol in people with Breast Cancer and Radical Mastectomy Surgery, run by Mansoura 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 14 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 11 Sep 2020. 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.
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?
Postoperative pain (time frame: For the first 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2020.