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NCT Number: NCT06837506

Ultrasound Guided Rectus Sheath Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Open Total Abdominal Hysterectomy

This study aims to compare the effectiveness and safety of ultrasound-guided rectus sheath block versus intrathecal morphine for postoperative analgesia in patients undergoing open total abdominal hysterectomy.

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Key information

Conditions

Ultrasound Intrathecal Morphine Postoperative Analgesia Rectus Sheath Block Total Abdominal Hysterectomy

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11591, Egypt

Location status: Recruiting

Location contact

Ahmed M Eldemerdash, MD

PRINCIPAL_INVESTIGATOR

Sarah A Afifi, MD

CONTACT

[email protected]

0501035864

Sondos Afifi, MD

PRINCIPAL_INVESTIGATOR

About this study

Effective postoperative analgesia is crucial for enhancing recovery and patient satisfaction following major surgical procedures, such as total abdominal hysterectomy (TAH).

Rectus sheath block (RSB), an ultrasound-guided regional anesthesia technique, involves the injection of local anesthetic into the rectus sheath, providing analgesia to the anterior abdominal wall. RSB is used to block the sensory nerves of the anterior abdominal wall and thereby contributing to pain relief after lower abdominal surgeries.

Intrathecal morphine (ITM) provides a highly effective method of analgesia by delivering the medication directly into the cerebrospinal fluid (CSF).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 - 65 years old.
  • American Society of Anesthesiologists (ASA) physical status (I -II).
  • Patients undergoing open total abdominal hysterectomy.

Exclusion criteria

  • Hepatic, renal, or cardiac disease.
  • Any known allergy to local anesthetic.
  • Physical or mental conditions which may vague measuring postoperative pain following surgery.
  • History of chronic use of analgesic as nonsteroidal anti-inflammatory drugs (NSAIDs) or central nervous system (CNS) depressants as antiepileptic, and bleeding disorders.

Treatment and study plan

Rectus sheath block

Drug

Patients will receive rectus sheath block (20 ml bilaterally, bupivacaine 0.25%) after induction of general anesthesia.

Other names: Bupivacaine 0.25%

Intrathecal morphine

Drug

Patients will receive 150 µg intrathecal morphine after induction of general anesthesia.

Primary outcomes

  1. Total morphine consumption

    Time frame: 24 hours postoperatively

    Morphine will be administered if the visual analog scale (VAS) score is ≥ 4.

Secondary outcomes

  1. Time to the first request for the rescue analgesia

    Time frame: 24 hours postoperatively

    Time to the first request for the rescue analgesia (time from the end of surgery till first dose of morphine administrated)

  2. Degree of pain

    Time frame: 24 hours postoperatively

    Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed after surgery over 24 hour using VAS scale at (post-anesthesia care unit, 2, 4, 6, 12, 18, and 24 h).

  3. Degree of sedation

    Time frame: Intraoperatively

    Sedation will be assessed using Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S): (5 Alert: Responds readily to name spoken in normal tone, 4: Lethargic response to name spoken in normal tone, 3: Responds only after name is called loudly and/or repeatedly, 2: Responds only after mild prodding or shaking ,1: Responds only after painful trapezius squeeze,0: Does not respond to painful trapezius squeeze).

  4. Degree of patient satisfaction

    Time frame: 24 hours postoperatively

    The degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).

  5. Time of hospital discharge

    Time frame: 28 days postoperatively

    Time of hospital discharge will be recorded from admission till the discharge from hospital.

  6. Incidence of adverse events

    Time frame: 24 hours postoperatively

    Incidence of adverse events such as hematoma, nerve damage or neuropathy, bradycardia, hypotension, nausea, vomiting, pruritis, or any other complication will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah A Afifi, MD

CONTACT

[email protected]

0501035864

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Ultrasound Guided Rectus Sheath Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Open Total Abdominal Hysterectomy: A Randomized Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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