Erector Spinae Block in Reducing Peri-operative Opioid Consumption in Total Abdominal Hystrectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®), Placebo.
- Who it may be relevant to
- Registry conditions: Erector Spinae Block, Enhanced Recovery After Surgery (ERAS) Protocol, Opioid. Basic parameters: 16 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Opioid Sparing Effect of Erector Spinae Block in Patients Undergoing Total Abdominal Hysterectomy; A Randomized Control Trial
Overview
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.
Detailed 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.
Interventions
- Drug Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)
Bilateral Erector Spinae Block at T10 level using 30ml of 0.25% Bupivacaine will be administered under Ultrasound guidance before surgical incision. - Drug Placebo
Bilateral Erector Spinae Block at T10 level using 30ml of Normal saline will be administered under Ultrasound guidance before surgical incision.
Primary outcome measures
- Total Intra-operative Fentanyl consumption [Time frame: From surgical incision till end of surgery]
Secondary outcome measures (2)
- Total amount of IV Tramadol consumed in post operative period [Time frame: First 24 hours after surgery]
- Post operative pain score [Time frame: Baseline that is pain score upon arrival in post anesthesia care unit in the post operative period and then at 1hours ,2 hours ,4 hours,6 hours,12 hours and 24 hours in the post operative period]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Kulsoom Internation Hospital — Islamabad
Publications
- 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. PMID 37277703
Identifiers
NCT: NCT07178262 · ERC-030