Observational Retrospective Study on Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy

Study Overview
=================
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.

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

Conditions
-----------------
Pain, Postoperative, Hysterectomy, Morphine, Anesthesia, Spinal

Intervention / Treatment
-----------------
* Procedure: Administration of morphine by intrathecal route
* Procedure: Administration of morphine by intravenous route


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intrathecal morphine<br>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. | Procedure: Administration of morphine by intrathecal route<br>* 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.<br>|
| Intravenous morphine<br>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). | Procedure: Administration of morphine by intravenous route<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Constipation | The presence of opioid-induced constipation | After the end of surgery, in the first 48 postoperative hours | 
| Mobilization | Time of first mobilization after the surgical procedure | After the end of surgery, in the first 48 postoperative hours | 
| Intraoperative opioid consumption | Total opioid consumption | During the surgery | 
| Postoperative opioid consumption | Total opioid consumption | 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 | After the end of surgery, in the first 48 postoperative hours | 
| 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 | 
| 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 |