The effect of erector spinae plane block on fentanyl consumption during open abdominal hysterectomy: a randomised controlled study.
Mohamed Ahmed Hamed, Maged Labib Boules, Mohamed Abd El Moniem Mahmoud...
https://pubmed.ncbi.nlm.nih.gov/37277703Actively Recruiting
Phase 4
Age: 16Years - 80Years
FEMALE
Healthy Volunteers
ID07178262
Opioid Sparing Effect of Erector Spinae Block in Patients Undergoing Total Abdominal Hysterectomy; A Randomized Control Trial
Led by Kulsoom International Hospital · Updated on 2025-09-17
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Total abdominal hysterectomy involves removing the uterus through a large incision in the lower abdomen, which causes significant pain and increases the need for opioids during and after surgery. Researchers are studying whether using an erector spinae plane block, a type of nerve block, can reduce opioid use and its side effects like nausea, vomiting, and breathing problems in patients undergoing this surgery. Participants will be randomly assigned to receive either the erector spinae block using 30ml of 0.25% Bupivacaine or a placebo block with normal saline, both administered bilaterally at the T10 level under ultrasound guidance before surgery. This is a double-blind study, meaning neither the patient nor the medical team knows which treatment is given. During the study, opioid consumption during surgery and in the first 24 hours after will be measured. Pain scores will be recorded at several points after surgery, starting in the recovery unit and continuing up to 24 hours. These assessments will help determine the effectiveness of the nerve block in reducing pain and opioid use. The study is sponsored by Kulsoom International Hospital and plans to enroll female patients aged 16 to 80 undergoing elective hysterectomy.
CONDITIONS
Brief Title
Erector Spinae Block in Reducing Peri-operative Opioid Consumption in Total Abdominal Hystrectomy
Who Can Participate
Age: 16Years - 80Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Female patients aged 16 to 80 years
- American Society of Anesthesiologists (ASA) class I, II, or III
- Scheduled for elective hysterectomy under general anesthesia
You will not qualify if you...
- Lack of consent to participate
- Body mass index greater than 35 kg/m2
- Allergy to the study medicine
- History of opioid abuse or misuse disorder
- Presence of chronic pain
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Day of surgery
Participants receive a bilateral erector spinae block at the T10 level under ultrasound guidance before surgical incision, followed by total abdominal hysterectomy under general anesthesia.
1 visit (in-person) on the day of surgery
Post-operative Follow-up
Duration - 24 hours after surgery
Participants are monitored for pain and opioid consumption during the first 24 hours after surgery.
Multiple assessments at 0, 1, 2, 4, 6, 12, and 24 hours post surgery
Trial Site Locations
Total: 1 location
1
Kulsoom Internation Hospital
Islamabad, Federal, Pakistan, 44000
Actively Recruiting
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Research Team
W
Waqas Anjum, Principal Investigator, MBBS, FCPS
A
Abdul Rehman, MBBS,FCPS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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