None listed
Conditions
Brief summary
Significant postoperative pain can follow major surgical procedures for cancer breast . postoperative pain that not well controlled has a lot of negative consequences as the patient sufferings, more hospital costs with extended hospital stay, and it is a risk factor in the development of chronic post-mastectomy pain .Procedural interventions involving regional blocks are found to be more effective than pharmacologic means .Pecs 1 and 2 can provide effective postoperative analgesia for such procedures . Pecs 1 and 2 blocks are field blocks that aim to deposit the local anesthetic between the pectoralis major and minor muscles and between pectoralis minor and serratus anterior respectively to block the different peripheral nerves supplying breast and so providing complete analgesia for breast surgery . Dexmetomedine an alpha2 receptor agonist has been used as an adjuvant to local anesthetic for various regional anesthetic techniques with significant prolongation of duration of analgesia . Ketamine a N-methyl-D-aspartate receptor antagonist has a reported local anesthetic and analgesic properties .Studies on caudal administration of ketamine combined with the local anesthetic has shown that it is effective for prolonging the duration of postoperative analgesia. Very few studies about the efficacy of ketamine for prolonging the duration of analgesia when combined with local anesthetic for peripheral nerve blocks with different conclusions. Therefore our study was planned to compare the analgesic efficacy and safety of ultrasound guided Pecs 1 and 2 blocks with local bupivacaine versus bupivacaine added to either ketamine or dexmetomidine in patients undergoing breast cancer surgery.
Interventions
This is a randomized double blind prospective study will be conducted on 90 patients aged 18 years or above undergoing modified radical mastectomy. Patients will be randomly assigned into three groups (30 patients each).Patients in group ketamine bupivacaine (KB) will receive PECs block with 30 ml of 0.25% bupivacaine added to ketamine hydrochloride 1mg/kg .Patients in group dexmedetomidine bupivacaine (DB) will receive PECs block with 30 ml of 0.25%bupivacaine added to dexmedetomidine 1ug/kg .
This is a randomized double blind prospective study will be conducted on 90 patients aged 18 years or above undergoing modified radical mastectomy. Patients will be randomly assigned into three groups (30 patients each).Patients in group ketamine bupivacaine (KB) will receive PECs block with 30 ml of 0.25% bupivacaine added to ketamine hydrochloride 1mg/kg .Patients in group dexmedetomidine bupivacaine (DB) will receive PECs block with 30 ml of 0.25%bupivacaine added to dexmedetomidine 1ug/kg .Patients in bupivacaine group(B) will receive PECs block with 30 ml of 0.25%bupivacaine . The local anaesthesia will be prepared by our hospital pharmacy in unlabeled 30 ml syringes according to the randomization table and will be handed to the anaesthetist before starting the procedure.Both the patients and the anesthetist will beblinded to the study drug. In all patients general anesthesia 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 will be maintained by 1 MAC sevoflurane in 50% Oxygen /air mixture in a low flow breathing system (FiO2 = 0.5) . PECs block will be done in all patient by an anaesthetist blinded to the solution to be injected. PECs block will be done with an in plane Ultrasound guidance to inject 10 ml of the local anesthetic solution between pectoralis major and pectoralis minor muscles and 20 ml the needle is then advanced from the medial to lateral side parallel to the ultrasound beam and then 20ml of the solution is injected between the pectoralis minor and serratus anterior muscles
Sponsors
Amira Soliman
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Patients American Society of Anesthesiologists (ASA) classification score 1 to 3 scheduled for modified radical mastectomy
Exclusion criteria
patients with history of advanced cardiac disease or having sepsis, Those with prior surgery in areas above or below the clavicle or in the axillary region, Those with opioid dependence or alcohol or drug abuse, those with coagulopathy p, and those with psychiatric illness that prevent them from proper perception and assessment of pain,
Outcome results
None listed