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Observational Retrospective Study on Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05654363
Acronym
SPIN_GYN
Enrollment
670
Registered
2022-12-16
Start date
2023-03-13
Completion date
2023-06-01
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Spinal, Hysterectomy, Morphine, Pain, Postoperative

Brief 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. 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.

Interventions

PROCEDUREAdministration of morphine by intrathecal route

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.

PROCEDUREAdministration of morphine by intravenous route

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.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Numeric pain rating scale (NPRS)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

Secondary

MeasureTime frameDescription
Adverse eventsAfter the end of surgery, in the first 48 postoperative hoursAny adverse event, like sedation, itching, nausea, motor weakness, signs of local anesthetic toxicity
ConstipationAfter the end of surgery, in the first 48 postoperative hoursThe presence of opioid-induced constipation
MobilizationAfter the end of surgery, in the first 48 postoperative hoursTime of first mobilization after the surgical procedure
Intraoperative opioid consumptionDuring the surgeryTotal opioid consumption
Postoperative opioid consumptionAfter the end of surgery, in the first 48 postoperative hoursTotal opioid consumption
Rescue analgesiaAfter the end of surgery, in the first 48 postoperative hoursThe use of non-opioid rescue analgesics in case of NPRS \> 3, other than around the clock pain medications
Length of PACU stayTime from admission to dismissal from PACU, an average of 1 hourLength of stay in Postoperative Anesthesia Care Unit (PACU)
Length of hospital stayTime from dismissal from PACU to dismissal from hospital, an average of 72 hoursThe Length of Hospital Stay (LOS) after the surgery

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORStefano Catarci

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026