Bilateral Ultrasound Guided ESP Block Versus TAP Block on Post-operative Analgesia After Total Abdominal Hysterectomy

Not Applicable

Completed

• Conditions: Post-operative Analgesia
• Interventions: Procedure: 1) Ultrasound guided Erector spinae block; Procedure: Ultrasound guided transversus abdominis plane block

• Registration Number: NCT03965156
• Lead Sponsor: Zagazig University

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).

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-28
• Study Start: 2019-06-13
• Status Verified: 2019-10
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-11
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane Block	1) Ultrasound guided Erector spinae block	Bilateral Ultrasound Guided Erector Spinae Plane Block
transversus abdominis plane block	Ultrasound guided transversus abdominis plane block	Ultrasound guided transversus abdominis plane block

Primary Outcome Measures

Name	Time	Method
The total amount of morphine given to each patient	the first 24 hours postoperative.	The total amount of morphine given to each patient during the first 24h of postoperative period
The time to first call to analgesia (morphine)	first call to morphine up to 24 hours postoperative.	morphine (rescue analgesic) will be given if VAS\>3.
Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988).	at 30 minutes postoperative.	1- Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988). A commonly used visual analog scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border. The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. VAS score will be assessed at 30 minutes, 2hs, 4hs, 6hs, 12hs, and 24hs postoperative and IV increment of 3mg morphine (rescue analgesic) will be given if VAS\>3.
Pain intensity using Visual analogue Scale (VAS)	at 24 hours postoperative.	visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
"Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"	Up to 24 hours postoperative.	"Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"

Secondary Outcome Measures

Name	Time	Method
Over all patient satisfaction	all over 24 hours postoperative	Over all patient satisfaction:The patients will be asked to rate the overall degree of satisfaction of the analgesia using a 1-3 verbal scale (1 = unsatisfactory analgesia, 2 = satisfactory analgesia, and 3 = excellent analgesia) (Ross et al., 2009).

Trial Locations

Locations (1)

Zagazig University Hospitsals; 🇪🇬 Zagazig, Egypt