The Effect of Two Different Analgesic Techniques on Postoperative Recovery Quality

NCT ID: NCT06766994

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-25
• Study Completion Date: 2026-06-01

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.

Conditions

Abdominal Hysterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Group Intrathecal morphine

Group Type: ACTIVE_COMPARATOR

intrathecal morphine

Intervention Type: OTHER

Preoperatively, patients will be injected with 200 μg morphine intrathecally with a 27G pencil point spinal needle at the L4-L5 or L3-L4 intervertebral space in a sitting position.

Group Erector Spinae Plane Block

Group Type: ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type: OTHER

Preoperatively, patients will be placed in the prone position before the operation and an ESPB block will be applied bilaterally at the T9 vertebra level with the help of USG. 0.25% bupivacaine 20 ml will be used bilaterally as the blocking fluid.

Interventions

intrathecal morphine

Preoperatively, patients will be injected with 200 μg morphine intrathecally with a 27G pencil point spinal needle at the L4-L5 or L3-L4 intervertebral space in a sitting position.

Intervention Type: OTHER

Erector Spinae Plane Block

Preoperatively, patients will be placed in the prone position before the operation and an ESPB block will be applied bilaterally at the T9 vertebra level with the help of USG. 0.25% bupivacaine 20 ml will be used bilaterally as the blocking fluid.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Berivan Bozan

Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ataturk University

Erzurum, Yakutiye, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Berivan Bozan

Role: CONTACT

bbozan_93@hotmail.com

+90 (507) 613 12 76

Facility Contacts

Berivan Bozan, MD

Role: primary

bbozan_93@hotmail.com

+905076131276

References

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.

Reference Type: BACKGROUND

PMID: 10740540 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22150410 (View on PubMed)

Other Identifiers

B.30.2.YYU.0.01.00.00/105

Identifier Type: -

Identifier Source: org_study_id