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CompletedNCT05072184Updated Jul 26, 2022

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

An interventional study of ESP block in Post Operative Pain, sponsored by Fayoum University Hospital. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-26.

Sponsored by Fayoum University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

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Conditions studied

  • Post Operative Pain

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03

In context

Pain, Postoperative

5,227 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's enrollment of 100 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Fayoum University Hospital is the lead sponsor of 76 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    ESP block

    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

    Procedure: ESP block

  • Sham comparator
    Control

    The patients will be randomized into two groups: ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of saline on each side

    Procedure: ESP block

Interventions

  • ProcedureESP block

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

    Also known as: regional anesthesia

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What researchers measure

Primary outcomes

  1. The total intraoperative fentanyl consumption (μg)

    the total doses of intraoperative fentanyl consumption in (μg)

    Time frame: operative time in hours

Secondary outcomes

  1. intraoperative sevoflurane consumption (ml)

    intraoperative sevoflurane consumption (ml)

    Time frame: operative time in hours

  2. post-operative fentanyl consumption in (μg)

    post-operative fentanyl consumption in the first 24 hours (μg)

    Time frame: the first 24 hours postoperative

  3. VAS score

    visual analog score

    Time frame: the first 24 hours postoperative

  4. mean operative times (min)

    operative times duration in (min)

    Time frame: operative times in (min)

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Study locations

1 site
  • Fayoum University Hospital
    Al Fayyum, 63511, Egypt
08

References and documents

Publications

  • 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. PubMed 32547172 ↗
  • 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. PubMed 23945838 ↗
  • 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. PubMed 31118757 ↗
  • Hamed MA, Boules ML, Mahmoud MAEM, Abdelghaffar RA. The effect of erector spinae plane block on fentanyl consumption during open abdominal hysterectomy: a randomised controlled study. BMC Anesthesiol. 2023 Jun 5;23(1):194. doi: 10.1186/s12871-023-02156-3. PubMed 37277703 ↗

Individual participant data

Plan to share: No — no plane

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05072184
Lead sponsor
Fayoum University Hospital
Responsible party
Mohamed Ahmed Hamed (Associate professor, Fayoum University Hospital) — Principal investigator
First posted
Oct 8, 2021
Start date
Oct 1, 2021
Primary completion
Jul 1, 2022
Completion
Jul 15, 2022
Last update
Jul 26, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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