Observational Retrospective Study on Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy

Completed

• Conditions: Hysterectomy; Pain, Postoperative; Anesthesia, Spinal; Morphine
• Interventions: Procedure: Administration of morphine by intrathecal route; Procedure: Administration of morphine by intravenous route

• Registration Number: NCT05654363
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-16
• Status Verified: 2023-03
• Study Start: 2023-03-13
• Primary Completion: 2023-05-31
• Study Completion: 2023-06-01
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 670

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intrathecal morphine	Administration of morphine by intrathecal route	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.
Intravenous morphine	Administration of morphine by intravenous route	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).

Primary Outcome Measures

Name	Time	Method
Numeric pain rating scale (NPRS)	48 hours from baseline	Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	Time from dismissal from PACU to dismissal from hospital, an average of 72 hours	The Length of Hospital Stay (LOS) after the surgery
Intraoperative opioid consumption	During the surgery	Total opioid consumption
Mobilization	After the end of surgery, in the first 48 postoperative hours	Time of first mobilization after the surgical procedure
Postoperative opioid consumption	After the end of surgery, in the first 48 postoperative hours	Total opioid consumption
Adverse events	After the end of surgery, in the first 48 postoperative hours	Any adverse event, like sedation, itching, nausea, motor weakness, signs of local anesthetic toxicity
Constipation	After the end of surgery, in the first 48 postoperative hours	The presence of opioid-induced constipation
Rescue analgesia	After the end of surgery, in the first 48 postoperative hours	The use of non-opioid rescue analgesics in case of NPRS \> 3, other than around the clock pain medications
Length of PACU stay	Time from admission to dismissal from PACU, an average of 1 hour	Length of stay in Postoperative Anesthesia Care Unit (PACU)

Trial Locations

Locations (1)

Catarci Stefano; 🇮🇹 Roma, Italy