the Effect of Erector Spinae Plane Block on Fentanyl Consumption During Abdominal Hysterectomy

Post Operative Pain Clinical Trial

Official title:

the Effect of Erector Spinae Plane Block on Fentanyl Consumption During Abdominal Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072184
• Other study ID #: M546
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: July 2022
• Source: Fayoum University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 15, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

-

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• ESP block
ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of bupivacaine 0.25% on each side

Locations

Country	Name	City	State
Egypt	Fayoum University Hospital	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. Review. — View 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. — View 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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total intraoperative fentanyl consumption (µg)	the total doses of intraoperative fentanyl consumption in (µg)	operative time in hours
Secondary	intraoperative sevoflurane consumption (ml)	intraoperative sevoflurane consumption (ml)	operative time in hours
Secondary	post-operative fentanyl consumption in (µg)	post-operative fentanyl consumption in the first 24 hours (µg)	the first 24 hours postoperative
Secondary	VAS score	visual analog score	the first 24 hours postoperative
Secondary	mean operative times (min)	operative times duration in (min)	operative times in (min)