Clinical trial NCT06766994: The Effect of Two Different Analgesic Techniques on Postoperative Recovery Quality
Official title: The Effect of Two Different Analgesic Techniques on Postoperative Recovery Quality in Patients Undergoing Elective Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Hysterectomy
Keywords: abdominal hysterectomy
intrathecal morphine
erector spinal plane block
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Hysterectomy is one of the most frequently performed surgical procedures after Caesarean section in many countries of the world and involves the removal of the uterine corpus with or without the cervix (total hysterectomy) or without the cervix (subtotal or supracervical hysterectomy) to treat a range of gynecological problems. Hysterectomy is performed abdominally, vaginally with laparotomy, or using minimally invasive techniques (laparoscopy, robotic surgery). The abdominal route for hysterectomy is the preferred route in 60-80% of these surgeries.

Postoperative recovery is a complex condition affected by various factors such as patient characteristics, surgical procedure, and anesthesia. There are many tools available to measure recovery quality. In recent years, the concept of recovery quality perceived by the patient has attracted attention. The Quality of Recovery-40 questionnaire (QoR-40) is an assessment test used to assess recovery quality and health status in the early postoperative stages. QoR-40 consists of 40 questions that evaluate patients' pain, physical comfort, physical independence, psychological support, and emotional state. Quality of Recovery-15 (QoR-15) is a short postoperative recovery scale developed and validated by Stark et al. in 2013. It is an abbreviated version of the QoR-40 scale. It is easy to use because it is shorter and can be completed in a short time. As in QoR-40, it contains 15 questions that evaluate pain, physical comfort, physical independence, psychological support, and emotional state by the patient.

Facilitating the recovery process and optimizing postoperative pain management is an important part of perioperative care. Multimodal analgesia, which combines local anesthesia, peripheral and non-opioid analgesics to minimize systemic opioid requirements and opioid-related side effects, has become increasingly popular. Epidural analgesia, which provides both intraoperative and postoperative analgesia as a complement to general anesthesia for elective abdominal hysterectomy, is an approach applied to achieve balanced and multimodal analgesia. Thus, while the adverse effects of high doses, especially opioid analgesics, applied with a single method are reduced, more effective treatment can be provided for postoperative pain where drugs and other methods alone are insufficient to provide complete analgesia.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo abdominal hysterectomy surgery under general anesthesia
* Ages between 18-65
* American Society of Anesthesiologists classification I-II

Exclusion Criteria:

* Patients with a BMI ≥ 35,
* Patients with allergies to the drugs to be used in the study,
* Patients with severe liver or kidney failure,
* Patients with a history of long-term use of nonsteroidal anti-inflammatory and opioid analgesics,
* Patients with a history of gastrointestinal bleeding, peptic ulcers or inflammatory bowel disease,
* Patients with a history of diabetes or other neuropathic diseases,
* Patients who developed atrioventricular block and bradycardia before surgery,
* Patients with a history of serious underlying respiratory disease and psychiatric diseases,
* Patients with ASA stage 3 or higher,
* Patients who cannot use a patient-controlled analgesia (PCA) device,
* Patients who need to stop the drug used in the study during surgery for any reason,
* Patients who do not consent to participate in the study

Primary outcomes:
measure: Quality of recovery 24 hours after surgery assessed using the QoR-15 questionnaire
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: Total amount of opioids consumed
timeFrame: postoperative 24 hours
measure: pain scores with movement and at rest
timeFrame: postoperative 24 hours
measure: irst analgesic requirement
timeFrame: postoperative 24 hours
measure: Advers events
timeFrame: postoperative 24 hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
state: Yakutiye
Study officials:
References:
citation: Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
citation: Hein A, Rosblad P, Gillis-Haegerstrand C, Schedvins K, Jakobsson J, Dahlgren G. Low dose intrathecal morphine effects on post-hysterectomy pain: a randomized placebo-controlled study. Acta Anaesthesiol Scand. 2012 Jan;56(1):102-9. doi: 10.1111/j.1399-6576.2011.02574.x.