Clinical trial NCT05072184: the Effect of Erector Spinae Plane Block on Fentanyl Consumption During Abdominal Hysterectomy
Official title: the Effect of Erector Spinae Plane Block on Fentanyl Consumption During Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be conducted as a prospective, randomized, double-blind, parallel-group clinical trial.
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the effects of erector spinae plane block on intraoperative fentanyl consumption in patients undergoing abdominal hysterectomy under general anesthesia.

To our knowledge, no study in the literature demonstrates this effect.

Detailed description: This study will be performed in Fayoum University hospital after approval of the institutional ethics committee and written informed consent. This study will be conducted as a prospective, randomized, double-blind, parallel-group clinical trial.

Inclusion criteria:

* American Society of Anesthesiologists (ASA) physical status I, II patients who will be scheduled for elective abdominal hysterectomy.
* Age range above 18.

Exclusion criteria:

* Patient refusal.
* Significant renal, hepatic and cardiovascular diseases.
* History of allergy to one of the study drugs.
* Any contraindication to regional anesthesia such as local infection or bleeding disorders.
* Chronic opioid use, history of chronic pain and cognitive disorders.

The patients will be randomized into two groups: ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of bupivacaine 0.25% on each side and Control group who will undergo the same procedure but with an injection of 20 ml of saline on a 1:1 ratio using a computer-generated random table. The patient's assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the ESP block and will not be involved in further data collection or patient care. The patients and both the surgical and anesthesia teams, who are responsible for patient care and data collection are blinded from the group assignments.

Eligibility criteria: Inclusion Criteria:

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Inclusion criteria:

* American Society of Anesthesiologists (ASA) physical status I, II patients who will be scheduled for elective abdominal hysterectomy.
* Age range 18-70 years

Exclusion Criteria:

* Patient refusal.

  * Significant renal, hepatic, and cardiovascular diseases.
  * History of allergy to one of the study drugs.
  * Any contraindication to regional anesthesia such as local infection or bleeding disorders.
  * Chronic opioid use, history of chronic pain and cognitive disorders.

Primary outcomes:
measure: The total intraoperative fentanyl consumption (μg)
timeFrame: operative time in hours
Secondary outcomes:
measure: intraoperative sevoflurane consumption (ml)
timeFrame: operative time in hours
measure: post-operative fentanyl consumption in (μg)
timeFrame: the first 24 hours postoperative
measure: VAS score
timeFrame: the first 24 hours postoperative
measure: mean operative times (min)
timeFrame: operative times in (min)
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University Hospital
Study officials:
References:
citation: Boules ML, Goda AS, Abdelhady MA, Abu El-Nour Abd El-Azeem SA, Hamed MA. Comparison of Analgesic Effect Between Erector Spinae Plane Block and Transversus Abdominis Plane Block After Elective Cesarean Section: A Prospective Randomized Single-Blind Controlled Study. J Pain Res. 2020 May 19;13:1073-1080. doi: 10.2147/JPR.S253343. eCollection 2020.
citation: Azari L, Santoso JT, Osborne SE. Optimal pain management in total abdominal hysterectomy. Obstet Gynecol Surv. 2013 Mar;68(3):215-27. doi: 10.1097/OGX.0b013e31827f5119.
citation: Hamed MA, Goda AS, Basiony MM, Fargaly OS, Abdelhady MA. Erector spinae plane block for postoperative analgesia in patients undergoing total abdominal hysterectomy: a randomized controlled study original study. J Pain Res. 2019 Apr 30;12:1393-1398. doi: 10.2147/JPR.S196501. eCollection 2019.