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CompletedNCT05513196Updated Nov 10, 2022

Bilateral Erector Spinal Plan Block in Postoperative Analgesia After Total Abdominal Hysterectomy

An observational study in Postoperative Pain, sponsored by Kocaeli University. Completed at 1 site in Turkey. Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-11-10.

Sponsored by Kocaeli University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
160
Ages
40 Years to 70 Years
Sex
Female
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Study summary

The importance of effective postoperative pain management is well known. Overall, for total abdominal hysterectomy operations are related with severe postoperative pain. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Many regional anesthesia techniques can be preferred for total abdominal hysterectomy. The aim of this study is to investigate postoperative analgesia effect of erector spina plane block for total abdominal hysterectomy.

Read the detailed description

Postoperative pain, which starts with tissue damage as a result of surgical procedures, gradually decreases with wound healing and ends. Pain due to tissue damage is an acute pain that varies in severity according to its size and region. It creates physiopathological changes in many organs and tissues and has negative effects on systems. This situation causes serious postoperative morbidity and mortality in patients. For these reasons, postoperative pain control is very important. Inadequate pain control can cause acute pain to turn into chronic pain. The occurrence of pain in the diseased area before the operation, the severity of surgical tissue damage, environmental, psychological and genetic factors increase the rate of development of chronic pain.

Multimodal analgesia in postoperative pain management is a strategy that combines different analgesic methods to provide more effective analgesia and to reduce side effects. Compared to monotherapy, less dose requirement and better pain management are targeted thanks to the additive and synergistic effect of different analgesic drugs. Thanks to this reduced dose, the incidence of drug-related side effects in patients is also reduced.

Erector spina plan block (ESPB) is a new regional anesthesia method used especially in abdominal and thoracic surgeries. It was first described by Forero et al. for the treatment of thoracic neuropathic pain. ESP block in 2017 and 2018; Many case reports for analgesic purposes in cervical, thoracic, abdominal and pelvic pain have been published, but detailed clinical studies have not been found. Since then, it has been considered that this interfascial plane block can be applied as an alternative to the neuraxial block for certain surgeries.

Under the guidance of ultrasonography, regional anesthesia applications can be performed more safely, easily and effectively than methods such as electrical stimulation and loss of resistance based on the determination of superficial landmarks. Uncertainty about the relationship of the needle with the surrounding tissue in peripheral nerve blocks performed with the traditional blind method causes a higher risk of failure and complication of the application. For this reason, Erector spina plan blocks made in our clinic are performed under ultrasound guidance. Complication due to erector spina plane block (pneumothorax) was reported in only two articles. There is also a report in the literature reporting that lower thoracic erector spina plane block causes involuntary motor block. However, it is stated that the possible complications associated with the block may be due to the failure of the technique.

The erector spina plane block technique consists of an injection of 20 mL of 0.25% bupivacaine, guided by USG, between the erector spinae muscle and the transverse process below it. The procedure is performed after the patient is seated, in the prone position, or in the lateral decubitus position and the target vertebral level has been defined. A high frequency linear USG probe is placed 3 cm lateral to the spinous process. On the hyperechoic transverse process, hypoechoic M.latissimus dorsi and M.rector spina are defined. The needle is then advanced from cephal to caudal or from caudal to cephalad until it remains in the interfascial plane. The correct position of the needle is confirmed by observing intramuscular diffusion of the drug following bupivacaine injection.

In the studies, the effectiveness of the erector spina plan block was controlled with the Visual Pain Scale (VAS) in the postoperative period. Therefore, in our study, we evaluated the effectiveness of postoperative pain with VAS. In our study, the patients in the control group will be those who did not undergo the block procedure. There is a 10 cm long line drawn horizontally on the Visual Pain Scale. The left end of this line represents no pain (VAS 0), and the other end represents the most severe pain imaginable (VAS 10). The patient is asked to mark a point on this 10 cm line according to the severity of the pain at that moment.

In our clinic, the efficacy of erector spina plane block has been demonstrated in studies performed in various surgeries. These studies include cholecystectomy, thoracic surgery, breast surgery, etc. made in operations. It has been shown in the literature that erector spina plane block is also effective in total abdominal hysterectomy operation. In this study, we aimed to show the effectiveness of the erector spina plane block, which is routinely applied in our clinic to prevent postoperative pain after total abdominal hysterectomy operations.

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Conditions studied

  • Postoperative Pain

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Keywords

  • postoperative pain
  • total abdominal hysterectomy
  • erector spinae plan block
  • morphine
  • visuel analog scale
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 160 is above the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Kocaeli University is the lead sponsor of 210 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients who undergo elective total abdominal hysterectomy surgery

Inclusion criteria

  • ASA 1-2 patients
  • patients undergo elective total abdominal hysterectomy

Exclusion criteria

Exclusion Criteria:

  • patient refusal
  • ASA 3-4
  • obesity (body mass index >35 kg/m2)
  • infection of the skin at the site of needle puncture area patients
  • with known allergies to any of the study drugs
  • coagulopathy
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
160 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • ESPB Group

    Erector spinae plane block performed group.

    Procedure: Erector spinae plane block (ESPB)

  • Control Group

    Control group.

Interventions

  • ProcedureErector spinae plane block (ESPB)

    Bilateral erector spinae plane block will be performed with 20 mL, 0.25% bupivacaine at T9 level preoperatively.

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What researchers measure

Primary outcomes

  1. Morphine consumption

    Morphine consumption (mg) of patients with patient controlled analgesia device

    Time frame: Postoperative 24th hour

  2. Visuel analog scale

    visuel analog scale of patients

    Time frame: Postoperative 24th hour

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Study locations

1 site
  • Kocaeli University
    Kocaeli, Izmit 41350, Turkey
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References and documents

Publications

  • Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789. PubMed 29746445 ↗
  • Hamed MA, Goda AS, Basiony MM, Fargaly OS, Abdelhady MA. Erector spinae plane block for postoperative analgesia in patients undergoing total abdominal hysterectomy: a randomized controlled study original study. J Pain Res. 2019 Apr 30;12:1393-1398. doi: 10.2147/JPR.S196501. eCollection 2019. PubMed 31118757 ↗
  • De Cassai A, Geraldini F, Carere A, Sergi M, Munari M. Complications Rate Estimation After Thoracic Erector Spinae Plane Block. J Cardiothorac Vasc Anesth. 2021 Oct;35(10):3142-3143. doi: 10.1053/j.jvca.2021.02.043. Epub 2021 Feb 20. No abstract available. PubMed 33731296 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05513196
Lead sponsor
Kocaeli University
Responsible party
Engin Çetin (principal investigator, Kocaeli University) — Principal investigator
First posted
Aug 24, 2022
Start date
Jan 1, 2022
Primary completion
Jul 1, 2022
Completion
Jul 1, 2022
Last update
Nov 10, 2022

Study contacts

engin MD çetin
principal investigator · Kocaeli Universty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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