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

NCT ID: NCT03965156

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-13
• Study Completion Date: 2019-10-11

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).

Conditions

Post-operative Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Erector Spinae Plane Block

Bilateral Ultrasound Guided Erector Spinae Plane Block

Group Type: ACTIVE_COMPARATOR

1) Ultrasound guided Erector spinae block

Intervention Type: PROCEDURE

In the lateral position, after skin sterilization, erector spinae plane block will be performed at the level of T9. Counting down from the spine of seventh cervical vertebrae, the spine of the nine thoracic vertebrae (T9). A linear low frequency ultrasound transducer (US) (3-5 MHz) will placed sagittal 3cm lateral to midline to visualize the muscles of the back, transverse process and simmering pleura in between transverse processes. A 22-gauge short bevel needle will be inserted in cranial-caudal direction towards transverse process (TP) in plane to the US transducer until needle touched the TP crossing all the muscles. The location of the needle tip will be confirmed by visible normal saline fluid separating erector spinae muscle off the bony shadow of the transverse process on ultrasound imaging. Then 20 ml of bupivacaine 0.375% plus plus 5ug/ml adrenaline (1:200000) will be injected. The procedure will be repeated following the same steps on the other side of the back.

transversus abdominis plane block

Ultrasound guided transversus abdominis plane block

Group Type: ACTIVE_COMPARATOR

Ultrasound guided transversus abdominis plane block

Intervention Type: PROCEDURE

in supine position and after skin sterilization. The linear high frequency transducer (6-13 MHz) will be placed in the transverse plane to the the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest. The three abdominal wall muscles (external oblique, internal oblique, and transversus abdominis) are visualized. The needle inserted in plane and advanced anterior to posterior under continual visualization until the tip between the internal oblique and the transversus abdominis muscle. After negative aspiration, a 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000) will be injected. The success of the injection will be confirmed by separation of the internal oblique and transversus abdominis with a distinct pocket of local anesthetic in between. The procedure will be repeated following the same steps on the other side.

Interventions

1) Ultrasound guided Erector spinae block

In the lateral position, after skin sterilization, erector spinae plane block will be performed at the level of T9. Counting down from the spine of seventh cervical vertebrae, the spine of the nine thoracic vertebrae (T9). A linear low frequency ultrasound transducer (US) (3-5 MHz) will placed sagittal 3cm lateral to midline to visualize the muscles of the back, transverse process and simmering pleura in between transverse processes. A 22-gauge short bevel needle will be inserted in cranial-caudal direction towards transverse process (TP) in plane to the US transducer until needle touched the TP crossing all the muscles. The location of the needle tip will be confirmed by visible normal saline fluid separating erector spinae muscle off the bony shadow of the transverse process on ultrasound imaging. Then 20 ml of bupivacaine 0.375% plus plus 5ug/ml adrenaline (1:200000) will be injected. The procedure will be repeated following the same steps on the other side of the back.

Intervention Type: PROCEDURE

Ultrasound guided transversus abdominis plane block

in supine position and after skin sterilization. The linear high frequency transducer (6-13 MHz) will be placed in the transverse plane to the the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest. The three abdominal wall muscles (external oblique, internal oblique, and transversus abdominis) are visualized. The needle inserted in plane and advanced anterior to posterior under continual visualization until the tip between the internal oblique and the transversus abdominis muscle. After negative aspiration, a 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000) will be injected. The success of the injection will be confirmed by separation of the internal oblique and transversus abdominis with a distinct pocket of local anesthetic in between. The procedure will be repeated following the same steps on the other side.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Alshaimaa Abdel Fattah Kamel

lecturer of Anaesthesia ,and surgical intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alshaimaa Kamel, M.D

Role: PRINCIPAL_INVESTIGATOR

faculty of medicine ,zagazig universty

Locations

Zagazig University Hospitsals

Zagazig, , Egypt

Countries

Egypt

Other Identifiers

5423

Identifier Type: -

Identifier Source: org_study_id