COMPARISON of the EFFECT of TWO DIFFERENT ANALGESIS TECHNIQUES in ABDOMINAL HYSTERECTOMY

Not Applicable

Recruiting

• Conditions: Abdominal Hysterectomy

• Registration Number: NCT06815393
• Lead Sponsor: Ataturk Training and Research Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-01
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-04
• Study First Posted: 2025-02-07
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-02-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperatve Opioid Consumption	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 Outcome Measures

Name	Time	Method
Postoperative Pain Scores at movement and rest	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	postoperative 24 hour	Evaluation of quality of recovery 24 hours after the surgery assessed using QoR-40 questionnaire
Advers Event	postoperative 24 hour	incidence of side effects (nause, vomiting, urinary retention) for 24 hours

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Erzurum, Yakutiye, Turkey