Comparing two interventions for pain control in post operative period in patients undergoing lumbar spine surgery

Phase 2/3

Not yet recruiting

Conditions: Nerve root and plexus compressionsin diseases classified elsewhere,

Registration Number: CTRI/2025/04/085365

Lead Sponsor: Velammal medical college hospital and research institute

Brief Summary: After spine surgery,postoperative pain could be moderate to severe for more than half ofpatients.Surgical trauma, neuropathy and inflammation arefactors contributing to this.Erector spinae plane block isfascial plane block used widely for post operative analgesia of spinesurgeries.This involves injecting a local anesthetic into the plane between theerector spinae muscle and the transverse process of the vertebra. Thelocal anesthetic spreads on a plane caudally and cranially, allowing thesympathetic nerve fibers, as well as the spinal nerves’ dorsal and ventral ramito be blocked.Direct injection ofmorphine into the intrathecal space also allows to directly act onopioid receptors within the brain and substantia gelatinosa ofthe spinal cord resulting in a robust analgesia after spine surgeries.

The current study aimedto assess and compare the efficacy and safety of intrathecal morphinewith erector spinae plane block in patients undergoing electivelumbar spine surgeries.A total of 100 patients aged between 18 and 65 years ofeither sex will be selected from the patients posted for elective lumbar spine surgery. Patients will be divided into two groups: Group Apatients will receive 0.2 mg intrathecal morphine at any one space betweenL2-L5 level and Group B will receive bilateral erector spinae plane block atLumbar level L1-L5 by using 40 mL of 0.25 % bupivacaine before starting the surgery for postoperative analgesia. In theperioperative period, pain will be assessed by hemodynamic parameters(heart rate and mean arterial pressure,SpO2), visual analogue scale and patient satisfaction score. Timeto first rescue analgesic requirement and incidence of any adverse events willalso be noted.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

ASA 1 & 2 patients scheduled to undergo elective lumbar spine surgery.

Exclusion Criteria

1.Patient refusal.
2.Allergy to any of the study drugs.
3.Contraindications to regional technique e.g.,infection around site of block ,any coagulation disorder, sepsis.
4.History of analgesic dependence (long term use) and opiate tolerance.
5.Contraindications to intrathecal morphine e.g.,local infection in intrathecal administration site.
6.More than two level of vertebrae involving in surgery.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.VAS Score.	1.At the time of arrival in post-anesthesia care unit and then at 30 minutes, 1, 2, 4, 6, 12,24 and 48 hours. after operation.
2.Postoperative analgesia use paracetamol/tramadol usage.	1.At the time of arrival in post-anesthesia care unit and then at 30 minutes, 1, 2, 4, 6, 12,24 and 48 hours. after operation.

Secondary Outcome Measures

Name	Time	Method
1.Time to first analgesic requirement after surgery.	2.Incidence of intervention related side effects in both the groups(Post-operative nausea/vomiting, respiratory depression, pruritus, urinary retention, local anesthetic systemic toxicity,local hematoma ).

Trial Locations

Locations (1): Velammal medical college hospital and research institute,Madurai
🇮🇳
Madurai, TAMIL NADU, India
Velammal medical college hospital and research institute,Madurai
🇮🇳Madurai, TAMIL NADU, India
Dr Arfan ahmed J S
Principal investigator
7795194452
arfanahmed007@gmail.com