Rhomboid Intercostal and Subserratus Plane Block

Postoperative Pain Clinical Trial

Official title:

The Effect of Rhomboid Intercostal and Subserratus Plane Block on the Postoperative Analgesia of Patients Undergoing Radical Mastectomy: Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085263
• Other study ID #: 33206/07/19
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: September 6, 2022

Study information

• Verified date: September 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial will be conducted at Tanta University Hospitals, General Surgery Hospitals on female patients undergoing radical mastectomy

. All the patients will receive general anesthesia.

The patients will be randomly allocated into one of the following two groups;- - Control group (30 patients): The patients in this group will receive sham rhomboid intercostal and subserratus plane.

• Rhomboid intercostal and subserratus plane block group (30 patients): The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.

The primary outcome measure will be the total dose of morphine consumed in the first 24 h after surgery and the secondary outcome will be the postoperative pain score.

Description:

This prospective randomized controlled study will be carried out on female patients who will be presented for radical mastectomy in the general surgery department in Tanta university hospitals over three month duration and 6 months follow up that starts immediately after obtaining ethical committee approval, an informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.

Any unexpected risks that will appear during the research will be announced to the participants and to the ethical committee at time and adequate measures will be taken to resolve and avoid these risks.

Expected risks to the patients: patients enrolled in this study will minimal risk of local hematoma that which will be managed by adequate compression and minimal risk of infection that will be guarded against by adequate sterilization and prophylactic antibiotic.

There will be adequate supervision to maintain the privacy of patients and confidentiality of data.

There will be no conflict of interest, nor conflict with religion, law, or society standards.

The research will be beneficial to the society and has no risk of environmental pollution.

Upon arrival of the patient to the operating room, intravascular access will be established, fluid preload will be started, and basic monitor will be attached. After positioning and adequate sterilization of the back. The patients will be randomly allocated into two equal groups by the aid of computer-generated software of randomization; - • Control group (30 patients): The patients in this group will receive sham rhomboid intercostal and subserratus plane.

• Rhomboid intercostal and subserratus plane block group (30 patients): The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.

Anesthesia will be induced by fentanyl 1 ug/kg, propofol 1.5 mg/kg, and cis-atracurium 0.15 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to a mechanical ventilator with its parameters adjusted to maintain etCo2 32-36 mmhg. Anesthesia will be maintained by isoflurane 1% MAC in mixture of oxygen:air 1:1 with the use of low flow (1 ml/min).

All the patients will be connected to a bispectral index monitor with maintaining its value ranging 40-60. Increase in the BIS value over 60 will be managed by additional dose of fentanyl 1ug/kg till decrease the BIS below 60. If the BIS is still over 60, increasing the isoflurane 0.2 % MAC till it decreased below 60.

At the end of the surgery, switching off the inhalational anesthetics, reversal of muscle relaxation, and awake tracheal extubation will be done with transporting the patients to the PACU for postoperative follow up and monitoring.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 6, 2022
• Est. primary completion date: September 6, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Female patients

• Aged 40-75 years

• ASA class I-II

• Presented for elective radical mastectomy.

Exclusion Criteria:

• Patients refused to participate.

• Patients with known or suspected allergy to the used medication.

• Patients with preoperative chronic pain

• Patients received preoperative opioids or gabapentoids.

• Patients with major cardiac, renal, respiratory, or hepatic disease.

• Patients with potential risk of coagulopathy

• Uncooperative patients.

• Obese patients with BMI >36

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Regional Anesthesia Morbidity

Intervention

Procedure:
• Control group
The patients in this group will receive sham rhomboid intercostal and subserratus plane.
• Rhomboid intercostal and subserratus plane block group
The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.

Locations

Country	Name	City	State
Egypt	Tanta University hospitals	Tanta

Sponsors (2)

Lead Sponsor	Collaborator
Tanta University	Dr. Mohamed shebl Abdelghany

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The postoperative morphine consumprtion	3 mg morphine i.v will be given when the postoperative VAS score was 4 or more considering the total dose consumption in the first postoperative day not exceeding 15 mg	The first 24 hours postoperatively
Secondary	The postoperative pain score	The postoperative Visual analogue score	The first 24 hours postoperatively