Postoperative Pain Relief After Major Abdominal Gynecological Surgery

NCT ID: NCT05845385

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-06

Study Completion Date

2024-09-01

Brief Summary

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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.

Detailed Description

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Following faculty ethical committee approval and written informed consent, 81 patients were included in our prospective, randomized and double-blind study. Patients were divided into 3 groups: lumbar epidural block (Group E), TAP block (Group T), and wound infiltration (Group I). Demographic data, surgical characteristics, hemodynamic values, pain scores at rest and on movement, morphine consumption, additional analgesic requirement, side effects at 1, 2, 6, 12, 24, 36 and 48th hours after surgery, and patient satisfaction scores at 24 and 48th hours were recorded.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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lumbar epidural analgesia with bupivacaine

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.

Group Type ACTIVE_COMPARATOR

lumbar epidural analgesia with bupivacaine

Intervention Type PROCEDURE

postoperative analgesic method

transversus abdominis plane block with bupivacaine

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).

Group Type ACTIVE_COMPARATOR

transversus abdominis plane block with bupivacaine

Intervention Type PROCEDURE

postoperative analgesic method

wound infiltration with bupivacaine

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

Group Type ACTIVE_COMPARATOR

wound infiltration with bupivacaine

Intervention Type PROCEDURE

postoperative analgesic method

Interventions

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lumbar epidural analgesia with bupivacaine

postoperative analgesic method

Intervention Type PROCEDURE

transversus abdominis plane block with bupivacaine

postoperative analgesic method

Intervention Type PROCEDURE

wound infiltration with bupivacaine

postoperative analgesic method

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Hakki Unlugenc

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hakkı - Unlugenc, Proffessor

Role: STUDY_CHAIR

Cukurova University

Locations

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Cukurova University

Adana, , Turkey (Türkiye)

Site Status

Cukurova University

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MAS

Identifier Type: -

Identifier Source: org_study_id

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