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Completed

NCT Number: NCT05654363

Observational Retrospective Study on Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy

Perioperative multimodal analgesia, defined by the use of various analgesic medications targeting different drug receptors, provides adequate pain relief with minimal or no opiate consumption. Therefore, it represents one of the cornerstone of Enhanced Recovery After Surgery (ERAS) protocols, as the reduction in opioid use and the associated side effects may eventually reduce length of hospital stay, increase patient satisfaction and minimise the risk of long-term opioid use.

Regional and neuraxial anesthesia techniques are key interventions to provide successful analgesia in the context of a multimodal strategy. Intrathecal morphine, for its effectiveness and potential of reducing the need of intravenous postoperative opioids, seems an attractive option in the case of hysterectomy, one of the most common major surgical procedures performed in women, associated with severe postoperative pain even when performed laparoscopically.

The aim of our observational retrospective study is therefore to compare the analgesic efficacy and the safety of morphine administered by intrathecal route versus intravenous route during the first 48 hours after performance of laparoscopic/laparotomic hysterectomy.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Catarci Stefano

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult women American Society of Anaesthesiologists (ASA) physical status <= 3, scheduled for elective hysterectomy under general anesthesia between January 1st 2019 and December 31st 2021.

Exclusion criteria

  • patients with American Society of Anaesthesiologists (ASA) status > 3,
  • opioid use or history of opioid dependence,
  • chronic use of analgesic medications,
  • psychiatric disorders.

Treatment and study plan

Administration of morphine by intrathecal route

Procedure

Lumbar puncture was performed before the induction of general anesthesia, in the operating room. Spinal anesthesia was performed in sitting position using a midline approach into the L3-L4 or L4-L5 interspaces with a 25ga pencil-point spinal needle administering 75-100 mcg morphine, with or without local anesthetic (levobupivacaine 0,5% 10-15 mg or bupivacaine 0,5% 10-15 mg or ropivacaine 0,5% 10-15 mg), depending on the anesthesiologist's preference. General anesthesia was then conducted according to clinical practice. All patients were transferred in the Post-Anesthesia Care Unit (PACU) at the end of surgery. Throughout the first 48 postoperative hours, all patients were regularly evaluated in the hospital ward by a member of the Acute Pain Service Team.

Administration of morphine by intravenous route

Procedure

General anesthesia was conducted according to clinical practice and a morphine bolus was administered before emergence from anesthesia according to clinical needs. All patients were then transferred in the Post-Anesthesia Care Unit (PACU) at the end of surgery and received Patient-Controlled Analgesia (PCA) with morphine 1mg/mL (CADD®-Solis 2110 Infusion System, Smiths Medical ASD, Inc., USA, 1 mL bolus on demand, no background infusion, 7 minute lockout, max 8 mg/h). Throughout the first 48 postoperative hours, all patients were regularly evaluated in the hospital ward by a member of the Acute Pain Service Team.

Primary outcomes

  1. Numeric pain rating scale (NPRS)

    Time frame: Time 0 (= baseline, i.e. at the time of Postoperative Anesthesia Care Unit arrival)

    Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest

  2. Numeric pain rating scale (NPRS)

    Time frame: 6 hours from baseline

    Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest

  3. Numeric pain rating scale (NPRS)

    Time frame: 12 hours from baseline

    Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest

  4. Numeric pain rating scale (NPRS)

    Time frame: 24 hours from baseline

    Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest

  5. Numeric pain rating scale (NPRS)

    Time frame: 48 hours from baseline

    Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest

Secondary outcomes

  1. Adverse events

    Time frame: After the end of surgery, in the first 48 postoperative hours

    Any adverse event, like sedation, itching, nausea, motor weakness, signs of local anesthetic toxicity

  2. Constipation

    Time frame: After the end of surgery, in the first 48 postoperative hours

    The presence of opioid-induced constipation

  3. Mobilization

    Time frame: After the end of surgery, in the first 48 postoperative hours

    Time of first mobilization after the surgical procedure

  4. Intraoperative opioid consumption

    Time frame: During the surgery

    Total opioid consumption

  5. Postoperative opioid consumption

    Time frame: After the end of surgery, in the first 48 postoperative hours

    Total opioid consumption

  6. Rescue analgesia

    Time frame: After the end of surgery, in the first 48 postoperative hours

    The use of non-opioid rescue analgesics in case of NPRS > 3, other than around the clock pain medications

  7. Length of PACU stay

    Time frame: Time from admission to dismissal from PACU, an average of 1 hour

    Length of stay in Postoperative Anesthesia Care Unit (PACU)

  8. Length of hospital stay

    Time frame: Time from dismissal from PACU to dismissal from hospital, an average of 72 hours

    The Length of Hospital Stay (LOS) after the surgery

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

The Role of Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy: an Observational Retrospective Study (the SPIN_GYN Study)

Acronym: SPIN_GYN

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 16, 2022
Registry last updated
Feb 12, 2026

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

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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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