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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Morphine; Hysterectomy; Anesthesia, Spinal; Pain, Postoperative

Treatments: Procedure: Administration of morphine by intravenous route; Procedure: Administration of morphine by intrathecal route

Study type: Observational

Funder types: Other

Identifiers

NCT05654363

5421

Details and patient eligibility

About

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.

Enrollment: 670 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

670 participants in 2 patient groups

Intrathecal morphine

Description:

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.

Treatment:

Procedure: Administration of morphine by intrathecal route

Intravenous morphine

Description:

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).

Treatment:

Procedure: Administration of morphine by intravenous route