CClinicalTrials.gg
RecruitingNCT06815393Updated Feb 19, 2025

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

An interventional study of Intratechal Morphine and Transversalis Fascia Plane Block in Abdominal Hysterectomy, sponsored by Ataturk Training and Research Hospital. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by Ataturk Training and Research Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Abdominal Hysterectomy

Keywords

  • abdominal hysterectomy
  • intratechal morphine
  • transversalis fascia plane block
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Group Intratechal Morphine

    Other: Intratechal Morphine

  • Active comparator
    Group Transversalis Fascia Plane Block

    Other: Transversalis Fascia Plane Block

Interventions

  • OtherIntratechal Morphine

    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

  • OtherTransversalis Fascia Plane Block

    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.

05

What researchers measure

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

    Time frame: postoperatively 24 hours

Secondary outcomes

  1. Postoperative Pain Scores at movement and rest

    evaluation of pain scores during movement and rest within 24 hours postoperatively using Visual Analogue Scale

    Time frame: postoperatively 24 hours

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

    Evaluation of quality of recovery 24 hours after the surgery assessed using QoR-40 questionnaire

    Time frame: postoperative 24 hour

  3. Advers Event

    incidence of side effects (nause, vomiting, urinary retention) for 24 hours

    Time frame: postoperative 24 hour

06

Study locations

1 of 1 sites recruiting
  • Ataturk University
    Erzurum, Yakutiye 25100, Turkey
    Recruiting
07

Registry details

Key details

Study ID
NCT06815393
Lead sponsor
Ataturk Training and Research Hospital
Responsible party
Emirhan Akarsu (Resaerch Resident, Ataturk Training and Research Hospital) — Principal investigator
First posted
Feb 7, 2025
Start date
Feb 1, 2025
Primary completion
Feb 1, 2026 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Feb 19, 2025

Study contacts

Emirhan Akarsu
Contact
emirhanakarsu@gmail.com
+90 535 283 28 97

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion