Observational Retrospective Study on Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy

NCT05654363 | Completed

• 1 other identifier: 5421
• Study Type: observational
• Target: 670
• Locations: 1 country
• Sites: 1

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.

Conditions

Morphine; Pain, Postoperative; Hysterectomy; Anesthesia, Spinal

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Adverse events

  After the end of surgery, in the first 48 postoperative hours

• Constipation

  After the end of surgery, in the first 48 postoperative hours

• Mobilization

  After the end of surgery, in the first 48 postoperative hours

• Intraoperative opioid consumption

  During the surgery

• Postoperative opioid consumption

  After the end of surgery, in the first 48 postoperative hours

Study Arms (2)

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

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

Interventions

Administration of morphine by intravenous route PROCEDURE

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.

Intravenous morphine

Administration of morphine by intrathecal route PROCEDURE

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.

Intrathecal morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• patients with American Society of Anaesthesiologists (ASA) status \> 3,
• opioid use or history of opioid dependence,
• chronic use of analgesic medications,
• psychiatric disorders.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Catarci Stefano

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Stefano Catarci

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 16, 2022
• Study Start: March 13, 2023
• Primary Completion: May 31, 2023
• Study Completion: June 1, 2023
• Last Updated: February 12, 2026

Record last verified: 2023-03

Locations

IT (1)