A Study on Using Low-Dose Morphine During Complex Lower Back Surgery

Low-Dose Intrathecal Morphine in Multilevel Lumbar Spine Surgery: A Randomized Controlled Trial. - Low-Dose Intrathecal Morphine in Multilevel Lumbar Spine Surgery: A Randomized Controlled Trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060941

Enrollment

Registered

2026-03-15

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain after complex spine surgery

Interventions

Intervention Group: Low-dose Intrathecal Morphine (ITM) Amount: 0.2 mg preservative-free morphine in 2 ml normal saline. Route: Intrathecal injection at lumbar vertebral level L2-L3 using a 25 G

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists (ASA) physical status I or II, scheduled for elective lumbar spine surgery involving two or more levels

Exclusion criteria

Exclusion criteria: Exclusion criteria included refusal to participate, single-level procedure, minimally invasive, or revision surgery, history of hepatic or renal impairment, any contraindication to intrathecal injection (e.g., coagulopathy, local infection), known allergy to morphine and history of chronic opioid use or dependence

Design outcomes

Primary

Measure	Time frame
The primary outcome was the total dose of morphine consumed (via PCA) over the first 48 hours postoperatively	—

Secondary

Measure	Time frame
Secondary outcomes included VAS (score 0 = no pain, 10 = worst pain ever) at 1, 6, 18, 24, 36 and 48 hours after extubation, total intraoperative fentanyl consumption. Time to the first analgesic request was measured from extubation until the patient called for rescue analgesia. intraoperative heart rate (HR) and mean arterial blood pressure (MAP) before and after induction, after skin incision, 2 hours after skin incision and at skin closure were all recorded. Secondary outcomes also included postoperative HR, and MAP at 1, 6, 18, 24, 36 and 48 hours after extubation. Incidence of complications such as sedation, nausea, vomiting, pruritus, and respiratory depression were all recorded. Lastly, overall patient satisfaction was assessed 48 hours post-procedure using a 4-point ordinal scale with the response options: poor, satisfactory, very good, and excellent.	—

Measure

Time frame

Secondary outcomes included VAS (score 0 = no pain, 10 = worst pain ever) at 1, 6, 18, 24, 36 and 48 hours after extubation, total intraoperative fentanyl consumption. Time to the first analgesic request was measured from extubation until the patient called for rescue analgesia. intraoperative heart rate (HR) and mean arterial blood pressure (MAP) before and after induction, after skin incision, 2 hours after skin incision and at skin closure were all recorded. Secondary outcomes also included postoperative HR, and MAP at 1, 6, 18, 24, 36 and 48 hours after extubation. Incidence of complications such as sedation, nausea, vomiting, pruritus, and respiratory depression were all recorded. Lastly, overall patient satisfaction was assessed 48 hours post-procedure using a 4-point ordinal scale with the response options: poor, satisfactory, very good, and excellent.

—

Countries

Asia(except Japan)

Contacts

Public ContactMohamed Sayedalahl

King Abdullah Medical City Anesthesia Department

sayedalahl700@mans.edu.eg00966538590998

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026