Pain, Postoperative Clinical Trial
— SPIN_GYNOfficial title:
The Role of Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy: an Observational Retrospective Study (the SPIN_GYN Study)
NCT number | NCT05654363 |
Other study ID # | 5421 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 13, 2023 |
Est. completion date | June 1, 2023 |
Verified date | March 2023 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 670 |
Est. completion date | June 1, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Catarci Stefano | Roma |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric pain rating scale (NPRS) | Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest | Time 0 (= baseline, i.e. at the time of Postoperative Anesthesia Care Unit arrival) | |
Primary | Numeric pain rating scale (NPRS) | Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest | 6 hours from baseline | |
Primary | Numeric pain rating scale (NPRS) | Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest | 12 hours from baseline | |
Primary | Numeric pain rating scale (NPRS) | Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest | 24 hours from baseline | |
Primary | Numeric pain rating scale (NPRS) | Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest | 48 hours from baseline | |
Secondary | Adverse events | Any adverse event, like sedation, itching, nausea, motor weakness, signs of local anesthetic toxicity | After the end of surgery, in the first 48 postoperative hours | |
Secondary | Constipation | The presence of opioid-induced constipation | After the end of surgery, in the first 48 postoperative hours | |
Secondary | Mobilization | Time of first mobilization after the surgical procedure | After the end of surgery, in the first 48 postoperative hours | |
Secondary | Intraoperative opioid consumption | Total opioid consumption | During the surgery | |
Secondary | Postoperative opioid consumption | Total opioid consumption | After the end of surgery, in the first 48 postoperative hours | |
Secondary | Rescue analgesia | The use of non-opioid rescue analgesics in case of NPRS > 3, other than around the clock pain medications | After the end of surgery, in the first 48 postoperative hours | |
Secondary | Length of PACU stay | Length of stay in Postoperative Anesthesia Care Unit (PACU) | Time from admission to dismissal from PACU, an average of 1 hour | |
Secondary | Length of hospital stay | The Length of Hospital Stay (LOS) after the surgery | Time from dismissal from PACU to dismissal from hospital, an average of 72 hours |
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