Pain, PostoperativeSPIN_GYNNCT05654363
Observational Retrospective Study on Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy
An observational study of Pain, Postoperative and Hysterectomy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative, Hysterectomy, Morphine
- What is being tested?
- Administration of morphine by intrathecal route and Administration of morphine by intravenous route
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 670 participants
- Where
- 1 siteItaly
- Study dates
- 13 Mar 2023to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women American Society of Anaesthesiologists (ASA) physical status <= 3, scheduled for elective hysterectomy under general anesthesia, performed by laparoscopy or by laparotomy (with a Pfannenstiel incision or midline incision).
Who may be able to join
- 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.
Who cannot join
- patients with American Society of Anaesthesiologists (ASA) status > 3,
- opioid use or history of opioid dependence,
- chronic use of analgesic medications,
- psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy: an Observational Retrospective Study (the SPIN_GYN Study)
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.
- Conditions
- Pain, Postoperative, Hysterectomy, Morphine, Anesthesia, Spinal
- Being tested
- Administration of morphine by intrathecal route, Administration of morphine by intravenous route
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of morphine by intrathecal routeProcedure or surgery
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 routeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal morphine | Adult women American Society of Anaesthesiologists (ASA) physical status <= 3, scheduled for elective laparoscopic/laparotomic hysterectomy under general anesthesia between January 1st 2019 and December 31st 2021, who consented to the execution of a preoperative spinal analgesia with intrathecal morphine (as part of our standard practice) and who did not present any contraindications to lumbar puncture. Receives: Procedure: Administration of morphine by intrathecal route | |
| Intravenous morphine | Adult women American Society of Anaesthesiologists (ASA) physical status <= 3, scheduled for elective laparoscopic/laparotomic hysterectomy under general anesthesia between January 1st 2019 and December 31st 2021, who did not consent to the execution of a preoperative spinal analgesia or presented contraindications to lumbar puncture (coagulopathy or incorrect discontinuation of anticoagulant drugs, increased intracranial pressure, infection at the site of injection, major spinal deformities). Receives: Procedure: Administration of morphine by intravenous route |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest
Measured: Time 0 (= baseline, i.e. at the time of Postoperative Anesthesia Care Unit arrival)
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest
Measured: 6 hours from baseline
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest
Measured: 12 hours from baseline
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest
Measured: 24 hours from baseline
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest
Measured: 48 hours from baseline
Secondary outcomes (8)
Adverse events
Any adverse event, like sedation, itching, nausea, motor weakness, signs of local anesthetic toxicity
Measured: After the end of surgery, in the first 48 postoperative hours
Constipation
The presence of opioid-induced constipation
Measured: After the end of surgery, in the first 48 postoperative hours
Mobilization
Time of first mobilization after the surgical procedure
Measured: After the end of surgery, in the first 48 postoperative hours
Intraoperative opioid consumption
Total opioid consumption
Measured: During the surgery
Postoperative opioid consumption
Total opioid consumption
Measured: After the end of surgery, in the first 48 postoperative hours
Rescue analgesia
The use of non-opioid rescue analgesics in case of NPRS > 3, other than around the clock pain medications
Measured: After the end of surgery, in the first 48 postoperative hours
Length of PACU stay
Length of stay in Postoperative Anesthesia Care Unit (PACU)
Measured: Time from admission to dismissal from PACU, an average of 1 hour
Length of hospital stay
The Length of Hospital Stay (LOS) after the surgery
Measured: Time from dismissal from PACU to dismissal from hospital, an average of 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start13 Mar 2023
- Primary completion31 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Catarci, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654363
- Sponsor's protocol ID
- 5421
- Acronym
- SPIN_GYN
- Status last verified
- Mar 2023
- First submitted
- 5 Dec 2022
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy: an Observational Retrospective Study (the SPIN_GYN Study)
- ClinicalTrials.gov ID
- NCT05654363
- Acronym / sponsor ID
- SPIN_GYN / 5421
- Conditions
- Pain, Postoperative, Hysterectomy, Morphine, Anesthesia, Spinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal morphine | – | Procedure: Administration of morphine by intrathecal routeAdult women American Society of Anaesthesiologists (ASA) physical status <= 3, scheduled for elective laparoscopic/laparotomic hysterectomy under general anesthesia between January 1st 2019 and December 31st 2021, who consented to the execution of a preoperative spinal analgesia with intrathecal morphine (as part of our standard practice) and who did not present any contraindications to lumbar puncture. |
| Intravenous morphine | – | Procedure: Administration of morphine by intravenous routeAdult women American Society of Anaesthesiologists (ASA) physical status <= 3, scheduled for elective laparoscopic/laparotomic hysterectomy under general anesthesia between January 1st 2019 and December 31st 2021, who did not consent to the execution of a preoperative spinal analgesia or presented contraindications to lumbar puncture (coagulopathy or incorrect discontinuation of anticoagulant drugs, increased intracranial pressure, infection at the site of injection, major spinal deformities). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women American Society of Anaesthesiologists (ASA) physical status <= 3, scheduled for elective hysterectomy under general anesthesia, performed by laparoscopy or by laparotomy (with a Pfannenstiel incision or midline incision).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- patients with American Society of Anaesthesiologists (ASA) status > 3,
- opioid use or history of opioid dependence,
- chronic use of analgesic medications,
- psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of morphine by intrathecal routeLumbar 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. | Procedure or surgery | Intrathecal morphine |
| Administration of morphine by intravenous routeGeneral 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. | Procedure or surgery | Intravenous morphine |
Primary outcome
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
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
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
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
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
8 secondary outcomes
Adverse events
Time frame: After the end of surgery, in the first 48 postoperative hours
Constipation
Time frame: After the end of surgery, in the first 48 postoperative hours
Mobilization
Time frame: After the end of surgery, in the first 48 postoperative hours
Intraoperative opioid consumption
Time frame: During the surgery
Postoperative opioid consumption
Time frame: After the end of surgery, in the first 48 postoperative hours
Rescue analgesia
Time frame: After the end of surgery, in the first 48 postoperative hours
Length of PACU stay
Time frame: Time from admission to dismissal from PACU, an average of 1 hour
Length of hospital stay
Time frame: Time from dismissal from PACU to dismissal from hospital, an average of 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Catarci principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Hysterectomy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (NPRS) (time frame: Time 0 (= baseline, i.e. at the time of Postoperative Anesthesia Care Unit arrival)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.