Observational Retrospective Study on Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy

Pain, Postoperative Clinical Trial

— SPIN_GYN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05654363
• Other study ID #: 5421
• Status: Completed
• Start date: March 13, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Hysterectomy
• Morphine
• Pain, Postoperative

Intervention

Procedure:
• Administration 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.
• Administration 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.

Locations

Country	Name	City	State
Italy	Catarci Stefano	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

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