NCT05845385

Brief Summary

The aim of our study was to compare the effects of Lomber Epidural Analgesia (LEA), Transversus Abdominis Plane (TAP) block and Local Anesthetic Infiltration (LAI) on postoperative morphine consumption, time to first recue analgesic request, pain and patient satisfaction scores and side effects were compared in the patients undergoing major gynecologic/oncology lower abdominal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

May 6, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

April 26, 2023

Last Update Submit

September 4, 2024

Conditions

Postoperative Pain

Keywords

epidural analgesiapain scoremorphinetransversus abdominis plane blockwound infiltration

Outcome Measures

Primary Outcomes (1)

  • morphine consumption

    At the end of the surgery, the patients were allowed to use the patient controlled analgesia device (PCA). The PCA (CADD Legacy PCA pump, Smiths Medical MD, Inc. St. Paul, MN) was prepared with 40 mg morphine HCl in 100 ml saline. The PCA doses of morphine consisted of a bolus dose of 0.02 mg/kg every 15 minutes without a background infusion. Morphine consumption (mg) was evaluated and recorded postoperative 48 hours.

    change from baseline morphine comsumption at 48 hours

Secondary Outcomes (4)

  • pain scores

    change from baseline pain scores at 48 hours

  • patient satisfaction score

    postoperative 24 and 48 hours

  • time to first rescue analgesic

    postoperative 48 hours

  • side effects

    postoperative 48 hours

Study Arms (3)

lumbar epidural analgesia with bupivacaine

ACTIVE COMPARATOR

For postoperative analgesia; Lumbar epidural catheter inserted at L3-4 or L4-5 epidural space before anesthesia induction in the sitting position. After the end of surgery but approximately 20 minutes before extubation, 0.125% bupivacaine 20 ml administered through epidural catheter and the catheter was removed.

Procedure: lumbar epidural analgesia with bupivacaine

transversus abdominis plane block with bupivacaine

ACTIVE COMPARATOR

For postoperative analgesia; After the end of surgery but before extubation, USD-guided TAP block was performed with 0.125% bupivacaine 20 ml to the anatomic neurofacial space between the internal oblique and transersus abdominis muscles, bilaterally (10 ml for each side).

Procedure: transversus abdominis plane block with bupivacaine

wound infiltration with bupivacaine

ACTIVE COMPARATOR

For postoperative analgesia; After the end of surgery but before extubation, 0.125% bupivacaine 20 ml administered to the surgical incision site.

Procedure: wound infiltration with bupivacaine

Interventions

lumbar epidural analgesia with bupivacainePROCEDURE

postoperative analgesic method

lumbar epidural analgesia with bupivacaine
transversus abdominis plane block with bupivacainePROCEDURE

postoperative analgesic method

transversus abdominis plane block with bupivacaine
wound infiltration with bupivacainePROCEDURE

postoperative analgesic method

wound infiltration with bupivacaine

Eligibility Criteria

Age18 Years - 69 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study was conducted on female patients undergoing major abdominal gynecological surgery.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II,
  • between the age of 18-69,
  • undergoing major gynecological abdominal surgery under general anesthesia

You may not qualify if:

  • lack of patient consent
  • ASA \> III
  • sensitivity or contraindication to study drugs
  • conditions in which epidural anesthesia is contraindicated
  • emergency and urgent surgery
  • inability to comprehend pain scale
  • any contraindication to the use of patient controlled analgesia (PCA) device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cukurova University

Adana, 01130, Turkey (Türkiye)

Location

Cukurova University

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Hakkı - Unlugenc, Proffessor

    Cukurova University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 6, 2023

Study Start

May 6, 2024

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

TU(2)