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Completed

NCT Number: NCT05845385

Postoperative Pain Relief After Major Abdominal Gynecological Surgery

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University, Adana, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lumbar epidural analgesia with bupivacaine

Procedure

postoperative analgesic method

transversus abdominis plane block with bupivacaine

Procedure

postoperative analgesic method

wound infiltration with bupivacaine

Procedure

postoperative analgesic method

Primary outcomes

  1. morphine consumption

    Time frame: change from baseline morphine comsumption at 48 hours

    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.

Secondary outcomes

  1. pain scores

    Time frame: change from baseline pain scores at 48 hours

    postoperative pain scores of the patients were recorded using visual analog scale (VAS; 0=no pain, 10=worst pain)

  2. patient satisfaction score

    Time frame: postoperative 24 and 48 hours

    patient satisfaction scores were recorded using patient satisfaction scale (0= worst, 10=excellent)

  3. time to first rescue analgesic

    Time frame: postoperative 48 hours

    If the patients complained of pain despite the analgesia regimen, iv 50 mg meperidine was given as a rescue analgesic.

  4. side effects

    Time frame: postoperative 48 hours

    all patients were visited after surgery in the ward and side effects were evaluated and recorded

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Comparison of Lumbar Epidural Analgesia, Transversus Abdominis Plane Block and Wound Infiltration for Postoperative Pain Relief in Major Abdominal Gynecological Surgery

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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