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Postoperative PainErector SpinaeNCT03741348

Erector Spinae Plane Block For Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy

A study testing Erector Spinae Plane Block in people with Postoperative Pain, run by Fayoum University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to assess the efficacy of bilateral ESPB on postoperative analgesia in patients undergoing total abdominal hysterectomy under general anesthesia. Read more about this study

Who is it for?
Ages 40 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postoperative Pain
What is being tested?
Erector Spinae Plane Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
15 Nov 2017to 15 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • female patients
  • Aged 40 - 70 years,
  • Weighted 50 - 90 Kg
  • American society of Anesthesiologists physical status (ASA) class Ι to ΙΙΙ
  • Scheduled for elective total abdominal hysterectomy under general anesthesia

Who cannot join

  • Local infection at the site of puncture
  • Patients having a history of hematological disorders, including coagulation abnormality
  • Patients with severe hepatic impairment
  • Patients with chronic pain
  • A patient had a known allergy to study drugs.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mohamed

    Al Fayyum, 65345

Other trials in Egypt

About this study

Official title: Erector Spinae Plane Block For Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Controlled Study

The aim of this study was to assess the efficacy of bilateral ESPB on postoperative analgesia in patients undergoing total abdominal hysterectomy under general anesthesia.

Read the detailed description

60 patients Scheduled for elective total abdominal hysterectomy, after obtaining a written informed consent for anesthesia from each patient before enrolment in the study after explaining to them the nature of study.

Inclusion criteria included female patients aged 40 - 70 years, Weighted 50 - 90 Kg and with American society of anesthesiologists physical status (ASA) class Ι to ΙΙΙ Scheduled for elective total abdominal hysterectomy under general anesthesia. Exclusion criteria included Local infection at the site of puncture, Patients having history of hematological disorders, including coagulation abnormality, Patients with severe hepatic impairment, Patients with chronic pain and Patient had a known allergy to study drugs.

Patients were randomized into two equal groups. An online randomization program was used to generate random number list. Patient randomization numbers were concealed in opaque envelops which were opened by the study investigator.

Members of the study group involved in obtaining functional data were blinded to randomization for the period of data acquisition and analysis. Patients were randomly allocated into two groups:

Erector spinae plane block Group (ES): ultrasound guided erector spinae plane block at T9 vertebrae level with 20 ml of bupivacaine 0. 5%. Control Group (c): did not receive block.

One day before surgery all patients were interviewed to explain visual analogue scale (VAS), learned how to use patient controlled analgesia (PCA) pump and routine investigations were fulfilled.

In both groups Patients were monitored with ECG, non-invasive blood pressure monitoring and pulse oximetry. IV access was established and IV midazolam 0.01-0.02 mg.kg-1 was given.

In (ES) group After skin sterilization, ESPB was performed in sitting position at the level of T9 linear ultrasound (US) transducer (Phillips-Saronno Italy) was placed vertically 3cm lateral to midline to visualize the muscles of the back: the trapezius muscle above, the rhomboid major muscle in the middle and the erector-spinae muscle on the bottom, transverse process and simmering pleura in between the two transverse processes. After local infiltration of needle insertion site with 2-3ml of 2% lidocaine, a 22-gauge Short bevel needle (Spinocan, B.Braun Melsungen AG, Germany) was inserted in cranial-caudal direction towards transverse process (TP) in-plane to the US transducer until needle touched the TP crossing all the muscles. Correct needle placement was confirmed by Visualizing the needle in plane along its entire length, when it contacted the transverse process, 1 ml of anesthetic solution was injected. Hydrodissection of the interfascial plane between the erector spinae muscle and the transverse process was confirmed by visualizing the local anesthetic spreading in a linear pattern between the muscle and the bony acoustic shadows of the transverse process, ensuring correct localization. Then, up to 20 ml of bupivacaine 0.5% was injected. The procedure was repeated following the same steps on the other side of back. Control Group (c): the same pervious technique as in ES group but patient did not receive block.

Block success was tested by reduced cold sensation at planned surgical incision 5 minutes after block completion.

General anesthesia was induced with fentanyl 2 mcg.kg-1, propofol 2 mg.kg-1 followed by atracium 0.5 mg.kg-1 and after intubation Anesthesia was maintained with isoflurane (1 MAC) and atracium 0.1mg.kg-1 as a maintenance dose every 30 minutes till the end of the procedure; After emerging from anesthesia, the patients were transferred to the post aesthesia care unit (PACU) for a 2 hours observation period. The patients were discharged from the PACU after fulfilling the discharge criteria based on Aldrete score. Postoperative analgesia was provided in both groups immediately after surgery by PCA fentanyl pump then regular oral acetaminophen 1 g four times a day.

The criteria to stop fentanyl titration protocol were satisfactory pain control, Patient became sedated (Ramsay sedation scale >2), Respiratory rate < 12 / min, Oxygen saturation < 95% or development of serious adverse effects (allergy, severe vomiting, hypotension).

Visual analogue pain score (VAS) for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) was measured postoperatively at 30 min and 2, 4, 6, 12, and 24 hour postoperative.

Any side effects were recorded as nausea or vomiting, pneumothorax, or any other complications. Also Duration of hospital stays, from the first day postoperative until discharge.

The primary outcome of this study was Total fentanyl consumption in the first 24 hours And The secondary outcome was VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) was evaluated postoperatively at 30 min and 2, 4, 6, 12, and 24 hour postoperative, Duration of hospital stays and any complications.

Being tested
Erector Spinae Plane Block, control
Keywords
Erector Spinae Plane Block, Postoperative Analgesia, Total Abdominal Hysterectomy, fentanyl consumption
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erector Spinae Plane BlockProcedure or surgery

    In (ES) group After skin sterilization, ESPB was performed in sitting position at the level of T9 linear ultrasound (US) transducer (Phillips-Saronno Italy) was placed vertically 3cm lateral to midline to visualize the muscles of the back, transverse process and simmering pleura in between the two transverse processes. After local infiltration of needle insertion site with 2-3ml of 2% lidocaine, a 22-gauge Short bevel needle (Spinocan, B.Braun Melsungen AG, Germany) was inserted in cranial-caudal direction towards transverse process (TP) in-plane to the US transducer until needle touched the TP crossing all the muscles. Then, up to 20 ml of bupivacaine 0.5% was injected. The procedure was repeated following the same steps on the other side of back.

  • controlProcedure or surgery

    in control group, Erector Spinae Plane Block will not be done

Study groups in NCT03741348
Study groupRoleWhat they receive
ESActive comparatorErector Spinae Plane Block
Receives: Procedure: Erector Spinae Plane Block
controlPlacebo comparatorthe control group will not receive block
Receives: Procedure: control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fentanyl consumption

    in microgram

    Measured: first 24 hours postoperative

Secondary outcomes (6)
  1. Visual analog score

    ranging from 0 to 10, where 0 no pain and 10 maximum pain

    Measured: 30 minutes postoperative

  2. Visual analog score

    ranging from 0 to 10, where 0 no pain and 10 maximum pain

    Measured: 2 hours postoperative

  3. Visual analog score

    ranging from 0 to 10, where 0 no pain and 10 maximum pain

    Measured: 4 hours postoperative

  4. Visual analog score

    ranging from 0 to 10, where 0 no pain and 10 maximum pain

    Measured: 6 hours postoperative

  5. Visual analog score

    ranging from 0 to 10, where 0 no pain and 10 maximum pain

    Measured: 12 hours postoperative

  6. Visual analog score

    ranging from 0 to 10, where 0 no pain and 10 maximum pain

    Measured: 24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2018
  2. Study start15 Nov 2017
  3. Primary completion15 Sep 2018
  4. Study completion15 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03741348
Sponsor's protocol ID
R124
Acronym
Erector Spinae
Status last verified
Feb 2019
First submitted
11 Nov 2018
Last updated
22 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Azari L, Santoso JT, Osborne SE. Optimal pain management in total abdominal hysterectomy. Obstet Gynecol Surv. 2013 Mar;68(3):215-27. doi: 10.1097/OGX.0b013e31827f5119.

    PubMed 23945838
  • Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.

    PubMed 19020158
  • Ueshima H, Otake H. Similarities Between the Retrolaminar and Erector Spinae Plane Blocks. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):123-124. doi: 10.1097/AAP.0000000000000526. No abstract available.

    PubMed 27997492

Questions about this trial

What is this clinical trial studying?

A study testing Erector Spinae Plane Block in people with Postoperative Pain, run by Fayoum University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fentanyl consumption (time frame: first 24 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03741348, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.

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