Ataturk University
Erzurum, Yakutiye, 25100, Turkey (Türkiye)
Location status: Recruiting
Recruiting
NCT Number: NCT06815393
COMPARISON of the EFFECT of TWO DIFFERENT ANALGESIS TECHNIQUES in ABDOMINAL HYSTERECTOMY
Hysterectomy is one of the most commonly performed surgical procedures after cesarean section in many countries worldwide, especially among women of reproductive age. Postoperative pain is typically managed with oral and parenteral narcotics. Patient-controlled analgesia (PCA) is an effective pain management method that provides advantages such as faster pain relief, better dosage control, and elimination of the need for timer adjustments. Facilitating the recovery process and optimizing postoperative pain management are crucial components of perioperative care. To minimize systemic opioid requirements and opioid-related side effects, multimodal analgesia combining local anesthesia, peripheral, and non-opioid analgesics has become increasingly popular.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–65 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Women aged between 18 and 65 years classified as ASA 1 and ASA 2.
Exclusion criteria
- Patients with allergies to the active substance, those with severe liver or renal insufficiency, a history of long-term nonsteroidal anti-inflammatory drug (NSAID) and opioid analgesic use, a history of gastrointestinal bleeding, peptic ulcer or inflammatory bowel disease, a history of diabetes or other neuropathic conditions, preoperative atrioventricular block and bradycardia, underlying serious respiratory diseases, a history of psychiatric disorders, patients classified as ASA stage 3 or higher, patients weighing less than 40 kg, patients unable to use the patient-controlled analgesia (PCA) device, and patients who need to discontinue the study medication during surgery for any reason will be excluded from the study
Treatment and study plan
Intratechal Morphine
OtherPrior to induction, the patient will be positioned seated, and morphine will be slowly injected intrathecally at a dose of 5 μg/kg, adjusted to the L4-L5 or L3-L4 intervertebral space using a 27G pencil point spinal needle. The injection will be administered over approximately 10 seconds
transversalis fascia plane block
OtherPrior to induction, patients will be positioned supine, and bilateral transversus abdominis plane (TAP) block will be performed with the aid of ultrasound. As the blocking agent, 20 cc of 0.25% bupivacaine will be used bilaterally.
Primary outcomes
-
Postoperatve Opioid Consumption
Time frame: postoperatively 24 hours
The primary aim of this study is to compare the analgesic efficacy of intrathecal morphine and bilateral transversalis fascia plane block in patients undergoing elective abdominal hysterectomy, in terms of morphine consumption during the first 24 hours postoperatively
Secondary outcomes
-
Postoperative Pain Scores at movement and rest
Time frame: postoperatively 24 hours
evaluation of pain scores during movement and rest within 24 hours postoperatively using Visual Analogue Scale
-
Quality of recovery 24 hours after the surgery assessed using QoR-40 questionnaire
Time frame: postoperative 24 hour
Evaluation of quality of recovery 24 hours after the surgery assessed using QoR-40 questionnaire
-
Advers Event
Time frame: postoperative 24 hour
incidence of side effects (nause, vomiting, urinary retention) for 24 hours
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Ataturk Training and Research Hospital
Other
Registry information
Official study title
Comparison of the Analgesic Effect of Intrathecal Morphine and Bilateral Transversus Abdominis Plane Block in Patients Undergoing Elective Abdominal Hysterectomy
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Feb 7, 2025
- Registry last updated
- Feb 19, 2025
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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