NCT03741348

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

November 11, 2018

Last Update Submit

February 21, 2019

Conditions

Postoperative Pain

Keywords

Erector Spinae Plane BlockPostoperative AnalgesiaTotal Abdominal Hysterectomyfentanyl consumption

Outcome Measures

Primary Outcomes (1)

  • Fentanyl consumption

    in microgram

    first 24 hours postoperative

Secondary Outcomes (6)

  • Visual analog score

    30 minutes postoperative

  • Visual analog score

    2 hours postoperative

  • Visual analog score

    4 hours postoperative

  • Visual analog score

    6 hours postoperative

  • Visual analog score

    12 hours postoperative

  • +1 more secondary outcomes

Other Outcomes (3)

  • Age

    4 hours before operation once recruited

  • Weight

    4 hours before operation once recruited

  • Duration of surgery

    4 minutes after end of operation

Study Arms (2)

ES

ACTIVE COMPARATOR

Erector Spinae Plane Block

Procedure: Erector Spinae Plane Block

control

PLACEBO COMPARATOR

the control group will not receive block

Procedure: control

Interventions

Erector Spinae Plane BlockPROCEDURE

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.

ES
controlPROCEDURE

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

control

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed

Al Fayyum, 65345, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 23945838BACKGROUND

  • 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.

    PMID: 19020158BACKGROUND

  • 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.

    PMID: 27997492BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • mohamed a hamed, MD

    Fayoum University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia

Study Record Dates

First Submitted

November 11, 2018

First Posted

November 14, 2018

Study Start

November 15, 2017

Primary Completion

September 15, 2018

Study Completion

October 15, 2018

Last Updated

February 22, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)