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Postoperative Pain Relief After Major Abdominal Gynecological Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05845385
Enrollment
81
Registered
2023-05-06
Start date
2024-05-06
Completion date
2024-09-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

epidural analgesia, pain score, morphine, transversus abdominis plane block, wound infiltration

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.

Detailed description

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.

Interventions

PROCEDURElumbar epidural analgesia with bupivacaine

postoperative analgesic method

PROCEDUREtransversus abdominis plane block with bupivacaine

postoperative analgesic method

PROCEDUREwound infiltration with bupivacaine

postoperative analgesic method

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 69 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
morphine consumptionchange from baseline morphine comsumption at 48 hoursAt 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

MeasureTime frameDescription
pain scoreschange from baseline pain scores at 48 hourspostoperative pain scores of the patients were recorded using visual analog scale (VAS; 0=no pain, 10=worst pain)
patient satisfaction scorepostoperative 24 and 48 hourspatient satisfaction scores were recorded using patient satisfaction scale (0= worst, 10=excellent)
time to first rescue analgesicpostoperative 48 hoursIf the patients complained of pain despite the analgesia regimen, iv 50 mg meperidine was given as a rescue analgesic.
side effectspostoperative 48 hoursall patients were visited after surgery in the ward and side effects were evaluated and recorded

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026