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NCT Number: NCT03965156

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

* 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.

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Key information

Conditions

Post-operative Analgesia

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University Hospitsals

Zagazig, 055, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The total amount of morphine given to each patient

    Time frame: the first 24 hours postoperative.

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

  2. The time to first call to analgesia (morphine)

    Time frame: first call to morphine up to 24 hours postoperative.

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

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

    Time frame: 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.

  4. Pain intensity using Visual analogue Scale (VAS)

    Time frame: at 2 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.

  5. Pain intensity using Visual analogue Scale (VAS)

    Time frame: at 4 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.

  6. Pain intensity using Visual analogue Scale (VAS)

    Time frame: at 6 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.

  7. Pain intensity using Visual analogue Scale (VAS)

    Time frame: at 12 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.

  8. Pain intensity using Visual analogue Scale (VAS)

    Time frame: 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.

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

    Time frame: Up to 24 hours postoperative.

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

Secondary outcomes

  1. Over all patient satisfaction

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Bilateral Ultrasound Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block on Post-operative Analgesia After Total Abdominal Hysterectomy

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 28, 2019
Registry last updated
Oct 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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