Post operative pain relief in lumber spine surgery patients

Phase 4

Not yet recruiting

• Conditions: Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: M512||Other thoracic, thoracolumbar andlumbosacral intervertebral disc displacement,

• Registration Number: CTRI/2023/07/055003
• Lead Sponsor: M D M Hospital Dr S N Medical College Jodhpur

Brief Summary

All patients will undergo preoperative anaesthetic evaluation and will be explained about the visual analog scale (VAS) (0-10, where 0 =no pain and 10=worst imaginable pain). All patients will be kept fasting overnight and will be pre-medicated with tablet lorazepam 0.05 mg/kg and tablet ranitidine 150 mg orally the night before surgery. On the day of surgery, in the preoperative area, an intravenous line will be secured and normal saline infusion will be started. All patients will be premedicated with midazolam 2mg, metoclopramide 10 mg, and glycopyrrolate 0.2 mg intravenously half an hour before induction in the preoperative area.

Patients will undergo single-level lumbar canal decompression, in the standard prone position on a Wilson frame, via a midline incision, under general anesthesia. After shifting to the operation theatre, standard monitoring i.e. electrocardiogram (ECG), pulse oximetry (Spo2), noninvasive blood pressure (NIBP), end-tidal carbon dioxide (EtCO2), and body temperature will be started and baseline vital parameters will be recorded and monitoring will be continued till extubation. General anaesthesia will be induced with fentanyl 2 µg/kg, propofol 2-3 mg/kg till loss of verbal response and tracheal intubation will be facilitated by atracurium 0.5mg/kg, intravenously. Subsequently, anaesthesia will be maintained using isoflurane achieving an end-tidal concentration of 0.9 to 1.2% in a mixture of 60% N2O in O2. Neuromuscular relaxation will be maintained with intermittent atracurium bolus (0.15 mg/kg every 20 minutes). Ventilation will be adjusted to maintain EtCO2 between 30 and 35 mm Hg. Intraoperative rescue analgesia will be provided by intravenous fentanyl 0.5-1 μg/kg boluses as judged by an increase in heart rate or systolic blood pressure by more than 20% of the baseline.

Patients will be divided into three groups by using computer-generated random table numbers. At the end of the surgical procedure, after securing hemostasis and before final closure, in group M, a piece of absorbable gel foam soaked in inj morphine 5 mg (0.5 ml) + 10 ml of 0.9% sodium chloride will be placed in epidural space over the paraspinal region, above the nerve roots by the surgeon. In group R gel foam was soaked in 10 mL of 0.5% ropivacaine + 0.5 ml of 0.9% sodium chloride in epidural space and in group MR: Gelfoam soaked in inj morphine 5 mg (0.5 ml) + 10 mL of 0.5% ropivacaine in epidural space. After placing the gel foam, the drug solution will be allowed to remain in the wound for a contact time of 60 seconds. Thereafter, the wound will be closed in layers without mopping or suctioning.

All patients will be given inj ondansetron 0.1mg/kg prophylactically 30 minutes before reversal. At the end of surgery, patients will be turned supine and residual neuromuscular blockade will be reversed with i.v. neostigmine 50 µg.kg-1 and glycopyrrolate 10 µg.kg-1 and the trachea will be extubated when the patient is fully awake and breathing adequately and will be shifted to post anaesthesia care unit (PACU).

 In the postoperative period pain ratings, at rest and on movement, will be measured by a 0–10 visual analog scale (VAS) at intervals of 0, 1, 2, 4, 8, 12,18, and 24 hrs by an anaesthetist blinded to the drugs administered. Pulse, blood pressure (BP), and respiratory rate will also be noted during this time period. Tramadol 100 mg i/v slowly will be given as a rescue analgesic in case the patient’s VAS score is ≥ 4. Total 24-hour tramadol consumption and time to first request for rescue analgesic will be recorded. If VAS score ≥ 4 even after inj tramadol, inj paracetamaol 100 ml (1 gram) will be given as rescue analgesia. Side effects like nausea, vomiting, urinary retention, sedation, and adverse effects with the use of study drugs in all three groups will also be noted.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-07
• Study Start: 2023-07-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

ASA physical status I /II scheduled to undergo single-level lumbar laminectomy under general anaesthesia.

Exclusion Criteria

• 1 Body mass index ≥ 25 kg/m2 2 Moderate to severe heart or lung disease 3 History of previous lumbar spinal surgery 4 Prior neurological disease 5 Prior neuromuscular disease or psychological disease 6 History of preoperative opioid use or any history of substance abuse or on steroids 7 History of allergic reactions to local anesthetics.
• 8 Patients with excessive bleeding, cerebrospinal fluid leak, or requiring placement of a drain.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of postoperative analgesia in term of VAS score after epidural application of gel foam soaked in morphine ropivacaine morphine ropivacaine combination in patients undergoing single level lumbar laminectomy	24 HOURS

Secondary Outcome Measures

Name	Time	Method
1 Duration of analgesia	2 Total 24 hour rescue analgesic consumption

Trial Locations

Locations (1)

MDM hospital, Dr S N Medical collage, Jodhpur; 🇮🇳 Jodhpur, RAJASTHAN, India

MDM hospital, Dr S N Medical collage, Jodhpur

🇮🇳Jodhpur, RAJASTHAN, India

Dr Geeta Singariya

Principal investigator

9414803554

geetamanojkamal@gmail.com