A clinical trial to study the two different methods of pain management in patients undergoing posterior spine fusion surgery

Post-operative pain management with Intravenous Fentanyl, ketamine and magnesium combination patient controlled analgesia (PCA) compared with Epidural analgesia for children and adolescent patients undergoing posterior spine fusion surgery (PSF) â?? A randomized control trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/028145

Enrollment

Registered

2020-09-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: M411- Juvenile and adolescent idiopathicscoliosis

Interventions

Intervention1: IV PCA: IV PCA (Fentanyl, Ketamine, Magnesium), Fentanyl hourly max of 2-3 mcg/kg, Magnesium hourly max 2-3 mg/kg, Ketamine 0.1 mg/kg. The PCA setting will have both IV continuous basal

Eligibility

Inclusion criteria

Inclusion criteria: PATIENTS UNDERGOING MULTILEVEL POSTERIOR SPINAL FUSION, NORMAL SERUM MAGNESIUM LEVELS, HEALTHY ASA 1&2

Exclusion criteria

Exclusion criteria: 18 yrs, cognitive impairment, psychiatric illness, Neurological deficit, cardiac problems, renal problems, abnormal serum magnesium levels

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of two different analgesic techniques Intravenous PCA vs Epidural analgesia using visual analog pain scoreTimepoint: Pain score will be assessed at 0,6,12,24,36,48 hours respectively	—

Secondary

Measure	Time frame
1) To compare the effectiveness of both modalities in treating muscle spasms postoperatively. 2) To document the incidence of side effects including motor blockade, hypotension, pruritus, nausea, vomiting, giddiness, respiratory depression during first 48 hours after surgery. 3 ) Compare the time to ambulation after surgery between the two groups. 4) Patient satisfaction in both groups using verbal rating scale (1-10). Timepoint: 1) Muscle spasms will be assessed at 0,6,12,24,36,48 hours respectively 2) Side effects will be assessed at 0,6,12,24,36,48 hours respectively 3) To assess the time for first ambulation between two groups 4) Patient satisfaction score will be assessed at end of 48hrs in both groups	—

Measure

Time frame

1) To compare the effectiveness of both modalities in treating muscle spasms postoperatively. 2) To document the incidence of side effects including motor blockade, hypotension, pruritus, nausea, vomiting, giddiness, respiratory depression during first 48 hours after surgery. 3 ) Compare the time to ambulation after surgery between the two groups. 4) Patient satisfaction in both groups using verbal rating scale (1-10). Timepoint: 1) Muscle spasms will be assessed at 0,6,12,24,36,48 hours respectively 2) Side effects will be assessed at 0,6,12,24,36,48 hours respectively 3) To assess the time for first ambulation between two groups 4) Patient satisfaction score will be assessed at end of 48hrs in both groups

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Countries

India

Contacts

Public ContactKAVIARASAN A

CHRISTIAN MEDICAL COLLEGE, VELLORE

anjeyanth@gmail.com7358377164

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026