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Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block

Efficacy of Adding Tramadol as Adjunctive Analgesic With Levobupivacaine in Modified Pectoral Nerve Block for Modified Radical Mastectomy Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02625506
Enrollment
60
Registered
2015-12-09
Start date
2012-06-01
Completion date
2016-01-01
Last updated
2020-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Radical Mastectomy Surgery

Brief 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.

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)

Interventions

DRUGLevobupivacaine

Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine

DRUGLevobupivacaine and Tramadol

Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine in conjunction with tramadol

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists physical status I or II. * Patients scheduled for radical mastectomy surgery.

Exclusion criteria

* Severe or uncompensated cardiovascular diseases * renal diseases * Hepatic diseases * Endocrinal diseases. * Pregnancy * Postpartum * Lactating females * Allergy to study medications. * Local skin infection * Bleeding disorder * Coagulation abnormality * Spine deformity * chest deformity * Psychiatric disease

Design outcomes

Primary

MeasureTime frameDescription
Postoperative painFor the first 24 hours after surgeryPostoperative pain will be assessed by utilizing visual analogue scale (VAS)

Secondary

MeasureTime frame
Changes in blood pressureFor one hour after surgery
Changes in peripheral oxygen saturationFor one hour after surgery
Changes in heart rateFor one hour after surgery
Time for first analgesic request from extubationfor 24 hours after surgery
Total analgesics received for 24 hrs after surgeryfor 24 hours after surgery
Changes in end-tidal carbon dioxide tensionFor one hour after surgery

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026