Observational Retrospective Study on Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy (SPIN_GYN)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Hysterectomy; Anesthesia, Spinal; Morphine
• Intervention / Treatment: Procedure: Administration of morphine by intrathecal route; Procedure: Administration of morphine by intravenous route

• Study Type: Observational
• Enrollment (Actual): 670

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Catarci Stefano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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 midline incision).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intrathecal morphine; 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; 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.
Intravenous morphine; 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; 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.

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Stefano Catarci, Fondazione Policlinico Universitario A. gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 5421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No