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

NCT03965156 | Completed

• 1 other identifier: 5423
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Analgesia

Outcome Measures

Primary Outcomes (9)

• The total amount of morphine given to each patient

  The total amount of morphine given to each patient during the first 24h of postoperative period

  the first 24 hours postoperative.

• The time to first call to analgesia (morphine)

  morphine (rescue analgesic) will be given if VAS\>3.

  first call to morphine up to 24 hours postoperative.

• Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988).

  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.

  at 30 minutes postoperative.

• Pain intensity using Visual analogue Scale (VAS)

  visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.

  at 2 hours postoperative.

• Pain intensity using Visual analogue Scale (VAS)

  visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.

  at 4 hours postoperative.

• Pain intensity using Visual analogue Scale (VAS)

  visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.

  at 6 hours postoperative.

• Pain intensity using Visual analogue Scale (VAS)

  visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.

  at 12 hours postoperative.

• Pain intensity using Visual analogue Scale (VAS)

  visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.

  at 24 hours postoperative.

• "Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"

  "Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"

  Up to 24 hours postoperative.

Secondary Outcomes (1)

• Over all patient satisfaction

  all over 24 hours postoperative

Study Arms (2)

Erector Spinae Plane Block

ACTIVE COMPARATOR

Bilateral Ultrasound Guided Erector Spinae Plane Block

Procedure: 1) Ultrasound guided Erector spinae block

transversus abdominis plane block

ACTIVE COMPARATOR

Ultrasound guided transversus abdominis plane block

Procedure: Ultrasound guided transversus abdominis plane block

Interventions

1) Ultrasound guided Erector spinae block 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.

Erector Spinae Plane Block

Ultrasound guided transversus abdominis plane block 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.

transversus abdominis plane block

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitsals

Zagazig, 055, Egypt

Location

Study Officials

• Alshaimaa Kamel, M.D

  faculty of medicine ,zagazig universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Anaesthesia ,and surgical intensive care

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: June 13, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 11, 2019
• Last Updated: October 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)