Erector Spinae Block in Reducing Peri-operative Opioid Consumption in Total Abdominal Hystrectomy

Kulsoom International Hospital

Status and phase: Enrolling; Phase 4

Conditions: Opioid; Enhanced Recovery After Surgery (ERAS) Protocol; Erector Spinae Block

Treatments: Drug: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07178262

ERC-030

Details and patient eligibility

About

Hystrectomy is a surgical procedure that involves removal of uterus from the body of patient using a lower abdominal incision. This is an extremely painful procedure which causes discomfort and greatly increases opioids consumption in the peri-operative period. This can be reduced by using nerve blocks such as Erector spinae plane block.

Full description

Total abdominal hystrectomy is associated with significant pain due to large abdominal incision and significant surgical dissection. This greatly increases the consumption of Opioid in the peri-operative period. High dose opioid consumption is associated with constipation, nausea, vomiting and respiratory depression. This significantly hampers post operative recovery. Fascial plane blocks such as Erector spinae block provides significant analgesia greatly reducing opioid consumption and there by reducing the associated side effects.

Enrollment: 60 estimated patients

Sex: Female

Ages: 16 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) class: I, II and III .
• Elective Hysterectomy under General Anesthesia.

Exclusion criteria

• Lack of consent
• Body mass index >35 kg/m2
• Allergic to study medicine
• Opioid abuse or misuse disorder
• Chronic pain

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Erector spinae group

Active Comparator group

Description:

Patients in this group will receive bilateral erector spinae block at T10 level using 30ml of 0.25% Bupivacaine before surgical incision.

Treatment:

Drug: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)

Placebo

Placebo Comparator group

Description:

Patient in this group will receive Norma saline in Erector spinae block at T10 level bilaterally before surgical incision.

Treatment:

Drug: Placebo