Injection Site Haematoma, Local Anesthetic Toxicity
Conditions
Keywords
SAPB, MRM, pain management
Brief summary
The aim of this study is to compare the effect of ultra-sound guided serratus anterior plane block versus conventional IV analgesics in postoperative pain management in modified radical mastectomy (MRM)
Detailed description
All patients undergoing modified radical mastectomy were assigned to one of the following two groups:Group A: Serratus anterior plane block group (SAPB group): this group consists of 20 patients who received ultra sound guided serratus anterior plane block just after induction of anesthesia and Group B: IV analgesics group (control group): this group consists of 20 patients who did not receive any type of block.Further evaluations were carried out by a different investigator who was unaware of the patients' grouping. The degree of post-operative pain was assessed at: just upon arrival to the PACU, 2, 4, 8, 12 and 24 hours using the VAS score and the haemodynamic data and respiratory rate were measured during the first 24 hours after the end of the surgery. Postoperative analgesia regimen was standard in both groups; patients from each groups received 1 gm of Paracetamol Q 8 hours. Patients reporting VAS ( visual analogue score) score greater than 40, mean arterial blood pressure, heart rate or respiratory rate \>20% from the baseline, were given Pethidine (50 mg IV) as rescue analgesic. While, those reporting VAS score less than 40 with mean arterial blood pressure, heart rate or respiratory rate \>20% from the baseline but still complaining; Ketoralac (30 mg IV) was given with a maximum dose of 120 mg/ day.
Interventions
the patients receive local anesthetic (20 ml of Bupivacaine 0.25 %), injected superficial to the serratus muscle under ultrasound guidance.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
double blind
Intervention model description
A prospective, randomized, controlled clinical trial.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Females aged between 20-60 years old. * Preoperative physical status: ASA (American Society of Anesthesiology) I & II. * Body mass index (BMI) \< 35 Kg/ m2. * Candidate for unilateral modified radical mastectomy. * Informed consent to participate in the study.
Exclusion criteria
* \- Females aged \< 20 years old or \> 60 years old. * Preoperative physical status: ASA III & IV. * Morbid obese patients with BMI \> 35 Kg/ m2. * Refusal to participate in the study. * Addiction to narcotics or psycho-active drugs. * Psychological disorders. * Contra-indications to regional anesthesia (coagulopathy, injection site infection or allergy to any of the study drugs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the time of first rescue analgesic | it is measured for 24 hours after the end of surgery. | the time taken by the patient to receive first dose of rescue analgesia, guided by the patients VAS score ( if the patients VAS score is 4 or more, the patient receives 50 mg of Pethidine). |
| total dose of rescue analgesics | it is measured for 24 hours after the end of surgery. | the total dose of Pethidine needed by each patient measured in mg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patients satisfaction | 24 hours after the end of surgery. | patients satisfaction is measured on a scale from 0 to 10, where 0 means not satisfied at all and 10 means the ultimate satisfaction. |
| incidence of nausea and vomiting | 24 hours after the end of surgery. | patients are assessed for incidence of postoperative nausea and vomiting. |
| incidence of any block related complications. | 24 hours after the end of surgery. | incidence of any serratus anterior plane block complications (e.g. injection site hematoma, signs and/or symptoms of local anesthetic toxicity ) is detected. |
Countries
Egypt
Outcome results
None listed