Clinical trial NCT05654363: Observational Retrospective Study on Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy
Official title: The Role of Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy: an Observational Retrospective Study (the SPIN_GYN Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Hysterectomy
Morphine
Anesthesia, Spinal
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 670
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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 mini-midline incision).

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.


Eligibility criteria: 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,
* surgery including upper abdominal procedures (for example liver mobilization and diaphragm peritonectomy/resection, splenectomy) or xifo-pubic incision

Primary outcomes:
measure: Numeric pain rating scale (NPRS)
timeFrame: Time 0 (= baseline, i.e. at the time of Postoperative Anesthesia Care Unit arrival)
measure: Numeric pain rating scale (NPRS)
timeFrame: 6 hours from baseline
measure: Numeric pain rating scale (NPRS)
timeFrame: 12 hours from baseline
measure: Numeric pain rating scale (NPRS)
timeFrame: 24 hours from baseline
measure: Numeric pain rating scale (NPRS)
timeFrame: 48 hours from baseline
Secondary outcomes:
measure: Adverse events
timeFrame: After the end of surgery, in the first 48 postoperative hours
measure: Constipation
timeFrame: After the end of surgery, in the first 48 postoperative hours
measure: Mobilization
timeFrame: After the end of surgery, in the first 48 postoperative hours
measure: Intraoperative opioid consumption
timeFrame: During the surgery
measure: Postoperative opioid consumption
timeFrame: After the end of surgery, in the first 48 postoperative hours
measure: Rescue analgesia
timeFrame: After the end of surgery, in the first 48 postoperative hours
measure: Length of PACU stay
timeFrame: Time from admission to dismissal from PACU, an average of 1 hour
measure: Length of hospital stay
timeFrame: Time from dismissal from PACU to dismissal from hospital, an average of 72 hours
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Catarci Stefano
Study officials:
References: