Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
ID06815393

Comparison of the Analgesic Effect of Intrathecal Morphine and Bilateral Transversus Abdominis Plane Block in Elective Abdominal Hysterectomy

Led by Ataturk Training and Research Hospital · Updated on 2025-02-19

80

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two different pain relief methods for women undergoing elective abdominal hysterectomy, a common surgery especially after cesarean section. The study compares intrathecal morphine and bilateral transversus abdominis plane (TAP) block to improve postoperative pain control while minimizing opioid use and related side effects. This research is sponsored by Ataturk Training and Research Hospital and seeks to optimize recovery after surgery through better pain management strategies. Participants will receive either intrathecal morphine, administered via a spinal injection before anesthesia, or a bilateral TAP block using ultrasound guidance and bupivacaine. Both methods are given prior to surgery to help manage pain afterward. The study is randomized and quadruple-masked to fairly compare these two analgesic techniques. During the study, participants’ opioid use within the first 24 hours after surgery will be closely monitored as the main outcome. Researchers will also assess pain levels at rest and during movement, quality of recovery using a specific questionnaire, and any adverse events within 24 hours postoperation. The study involves careful follow-up during this period to evaluate the safety and effectiveness of the pain control methods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged between 18 and 65 years
  • Classified as ASA physical status 1 or 2
Not Eligible

You will not qualify if you...

  • Allergy to the active substances used in the study
  • Severe liver or kidney failure
  • History of long-term use of NSAIDs or opioid painkillers
  • History of gastrointestinal bleeding, peptic ulcer, or inflammatory bowel disease
  • History of diabetes or neuropathic conditions
  • Preoperative atrioventricular block or bradycardia
  • Serious respiratory diseases
  • History of psychiatric disorders
  • Classified as ASA stage 3 or higher
  • Weight less than 40 kg
  • Inability to use patient-controlled analgesia (PCA) device
  • Need to discontinue study medication during surgery for any reason

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants receive either intrathecal morphine injection or bilateral transversus abdominis plane block before undergoing elective abdominal hysterectomy surgery.

1 visit on surgery day (in-person)

Post-operative Follow-up

Duration - 24 hours post-surgery

Participants are monitored for postoperative opioid consumption, pain scores, quality of recovery, and adverse events for 24 hours after surgery.

1 follow-up visit within 24 hours after surgery (in-person)

Trial Site Locations

Total: 1 location

1

Ataturk University

Erzurum, Yakutiye, Turkey (Türkiye), 25100

Actively Recruiting

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Research Team

E

Emirhan Akarsu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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