Clinical trial NCT05126394: U/S Guided SAPB Versus Conventional IV Analgesics in Postoperative Pain Management in MRM
Official title: A Comparative Study Between Ultrasound-guided Serratus Anterior Plane Block and Conventional IV Analgesics in Postoperative Pain Management in Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injection Site Haematoma
Local Anesthetic Toxicity
Keywords: "SAPB"
"MRM"
"pain management"
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, controlled clinical trial.
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: the time of first rescue analgesic
timeFrame: it is measured for 24 hours after the end of surgery.
measure: total dose of rescue analgesics
timeFrame: it is measured for 24 hours after the end of surgery.
Secondary outcomes:
measure: patients satisfaction
timeFrame: 24 hours after the end of surgery.
measure: incidence of nausea and vomiting
timeFrame: 24 hours after the end of surgery.
measure: incidence of any block related complications.
timeFrame: 24 hours after the end of surgery.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
state: Abbasia
Study officials:
affiliation: Anesthesia department, Ain Shams University, Cairo, Egypt.
name: Hala Gomaa Salama, Medical Doctorate
role: STUDY_DIRECTOR
affiliation: Anesthesia department, Ain Shams University, Cairo, Egypt.
name: Hanan Mahmoud Farag, Medical Doctorate
role: STUDY_DIRECTOR
References: