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

NCT06815393 | Recruiting

• 1 other identifier: 2024-04/07
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Hysterectomy

Keywords

abdominal hysterectomy; intratechal morphine; transversalis fascia plane block

Outcome Measures

Primary Outcomes (1)

• Postoperatve Opioid Consumption

  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

  postoperatively 24 hours

Secondary Outcomes (3)

• Postoperative Pain Scores at movement and rest

  postoperatively 24 hours

• Quality of recovery 24 hours after the surgery assessed using QoR-40 questionnaire

  postoperative 24 hour

• Advers Event

  postoperative 24 hour

Study Arms (2)

Group Intratechal Morphine

ACTIVE COMPARATOR

Other: Intratechal Morphine

Group Transversalis Fascia Plane Block

ACTIVE COMPARATOR

Other: Transversalis Fascia Plane Block

Interventions

Intratechal Morphine OTHER

Prior 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

Group Intratechal Morphine

Transversalis Fascia Plane Block OTHER

Prior 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.

Group Transversalis Fascia Plane Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged between 18 and 65 years classified as ASA 1 and ASA 2.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk Training and Research Hospital: lead

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Emirhan Akarsu

CONTACT

+90 535 283 28 97; emirhanakarsu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resaerch Resident

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 7, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

TU (1)