Clinical trial NCT03965156: Bilateral Ultrasound Guided ESP Block Versus TAP Block on Post-operative Analgesia After Total Abdominal Hysterectomy
Official title: Bilateral Ultrasound Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block on Post-operative Analgesia After Total Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Analgesia
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-05-28
Enrollment: 48
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Abdominal hysterectomy is an open surgical procedure associated with considerable post-operative pain. Narcotics are often required during patient recovery but can result in adverse side effects. Transversus abdominis plane block(TAP block) is a regional anesthetic technique that is found to be effective as post-operative analgesia after total abdominal hysterectomy. Recently, erector spinae plane block(ESP)block is found to be safe, and simple regional anesthetic technique that decrease total opioid consumption in patient undergoing breast, or abdominal surgery.
* The aim is to compare the efficacy of bilateral erector spinae plane block, and bilateral transversus abdominis plane block on postoperative analgesia in patients after abdominal hysterectomy under general anesthesia, and their need for opioid.

Hypothesis

* Null hypothesis (H0): No difference between the analgesic effects of bilateral erector spinae plane block, and bilateral transversus abdominis plane block in patients after abdominal hysterectomy under general anesthesia.
* Alternative hypothesis (H1): There are difference between the analgesic effects of bilateral erector spinae plane block, and bilateral transversus abdominis plane block in patients after abdominal hysterectomy under general anesthesia.

Detailed description: Sample size: Assuming that Mean±SD of reduced pain scores in erector spinae plane block is 4.7±3.7 versus 2.5±1 in transversus abdominis plane block.So, the total sample size is 48 cases (24 in each group) using Open Source Statistics for Public Health (open Epi) with confidence interval 95% and power of test is 80%.

d) Method of sample collection:

Forty eight female patients will be divided into two groups by a computer-generated randomization table:

Group (ES) (n=24): will receive bilateral ultrasound guided erector spinae plane block with each block 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000) at the level of T9.

Group (TA) (n=24): will receive bilateral ultrasound guided transversus abdominis plane block with each block 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000).

Eligibility criteria: Inclusion Criteria:

* Female Patient.
* Patient acceptance.
* Age (40-60) years old.
* American Society of Anaesthesiologist (ASA) I / II
* Elective total abdominal hysterectomy under general anesthesia.
* patient With Body Mass Index (BMI) (25-35kg/m²)

Exclusion Criteria:

* Patient refusal.
* Local infection at site of puncture.
* Altered mental status.
* History of allergy to study drugs ( bupivacaine, morphine).
* Patients with chronic pain.
* Patients with severe hepatic or kidney impairment.
* Patients having a history of hematological disorders, including coagulation abnormality.

Primary outcomes:
measure: The total amount of morphine given to each patient
timeFrame: the first 24 hours postoperative.
measure: The time to first call to analgesia (morphine)
timeFrame: first call to morphine up to 24 hours postoperative.
measure: Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988).
timeFrame: at 30 minutes postoperative.
measure: Pain intensity using Visual analogue Scale (VAS)
timeFrame: at 2 hours postoperative.
measure: Pain intensity using Visual analogue Scale (VAS)
timeFrame: at 4 hours postoperative.
measure: Pain intensity using Visual analogue Scale (VAS)
timeFrame: at 6 hours postoperative.
measure: Pain intensity using Visual analogue Scale (VAS)
timeFrame: at 12 hours postoperative.
measure: Pain intensity using Visual analogue Scale (VAS)
timeFrame: at 24 hours postoperative.
measure: "Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"
timeFrame: Up to 24 hours postoperative.
Secondary outcomes:
measure: Over all patient satisfaction
timeFrame: all over 24 hours postoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitsals
Study officials:
affiliation: faculty of medicine ,zagazig universty
name: Alshaimaa Kamel, M.D
role: PRINCIPAL_INVESTIGATOR
References: