Pre-emptive Caudal Epidural Analgesia With Ropivacaine With or Without Dexamethasone in Lumbosacral Spine Surgery

Post Operative Pain Clinical Trial

Official title:

A Randomized Case Control Study of Pre-emptive Caudal Epidural Analgesia With Ropivacaine With and Without Dexamethasone for Lumbosacral Spine Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05904275
• Other study ID #: NationalTraumaCenter
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: June 2023
• Source: National Trauma Center
• Contact: Jay Pr Thakur, MD, FIPM
• Phone: 9849001429
• Email: dr_jay2002[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lumbosacral spine surgeries are commonly performed under GA. Perioperative pain following spine surgeries not only contributes to significant morbidities but also hampers early mobilization. Perioperative opioids, though relieve pain but hampers consciousness, increase PONV and delays mobilization. Caudal analgesia can be effectively given preemptively to alleviate pain and facilitate early mobilization. Caudal epidural block places the needle through the sacral hiatus into the epidural space to deliver medications. It can be performed as ultrasound guided procedure with very high successful rates. Single shot caudal block with local anesthetic provides analgesia for 2-4 hours but this can be further prolonged by adding adjuvants like opioids, steroids, ketamine, alpha 2 agonists, adrenaline etc. Ropivacaine is a long-acting amide local anesthetic agent which is less lipophilic, less cardiac and central nervous system toxicity with similar duration of analgesia, has lesser motor blockade and facilitates earlier mobilization than bupivacaine. Dexamethasone is a highly potent, long acting glucocorticoid. Caudal dexamethasone prolongs the analgesic duration of the ropivacaine. The aim of this study is to evaluate the role of pre-emptive caudal epidural analgesia for postoperative pain relief in lumbosacral surgeries and to compare the effect of adding dexamethasone to ropivacaine with respect to quality of analgesia, duration of analgesia, hemodynamic effects and associated side effects.

Description:

Lumbosacral spine surgeries are commonly performed under GA. Perioperative pain following spine surgeries not only contributes to significant morbidities but also hampers early mobilization. Perioperative opioids, though relieve pain but hampers consciousness, increase PONV and delays mobilization. Caudal analgesia can be effectively given preemptively to alleviate pain and facilitate early mobilization. Caudal epidural block places the needle through the sacral hiatus into the epidural space to deliver medications. It can be performed as ultrasound guided procedure with very high successful rates. Single shot caudal block with local anesthetic provides analgesia for 2-4 hours but this can be further prolonged by adding adjuvants like opioids, steroids, ketamine, alpha 2 agonists, adrenaline etc. Ropivacaine is a long-acting amide local anesthetic agent which is less lipophilic, less cardiac and central nervous system toxicity with similar duration of analgesia, has lesser motor blockade and facilitates earlier mobilization than bupivacaine. Dexamethasone is a highly potent, long acting glucocorticoid. Caudal dexamethasone prolongs the analgesic duration of the ropivacaine. The aim of this study is to evaluate the role of pre-emptive caudal epidural analgesia for postoperative pain relief in lumbosacral surgeries and to compare the effect of adding dexamethasone to ropivacaine with respect to quality of analgesia, duration of analgesia, hemodynamic effects and associated side effects.

Patients will be allocated in one of the two groups, I and II, consisting of 30 each, using a lottery based random number. A box containing 60 chits, with 30 labelled as group I and other 30 as group II, will be given to each patient and will be asked to take out 1 chit. The group allocated will be written in separate paper by an anesthesiologist, who will also prepare drugs. Decoding will be done later after completion of all data collection. The patient in Group I will be given caudal epidural injection with 0.25% ropivacaine 20 ml containing dexamethasone 8 mg (0.5% Ropivacaine 10 ml + 8 mg/2 ml Dexamethasone + 8 ml NS) and group II will be give 0.25% ropivacaine 20 ml. All the data collection will be done by another anesthesiologist, not involved in group allocation, drug preparation and administration.

At preoperative visit, all patients will be made familiar with VAS score for pain assessment and will be recorded. At operation theatre, standard American Society of Anesthesiologists (ASA) monitoring, including electrocardiography, noninvasive blood pressure, pulse oximetry and endtidal carbon dioxide, will be applied and measured. Patient's vitals will be recorded at preinduction, induction, postintubation, after caudal injection, time of incision, and at 15 min intervals till half an hour after completion of surgery. Intravenous (IV) line will be secured, and inj. Ringer Lactate (RL) 500 ml will be administered. Anesthesia will be induced with inj. Midazolam 0.04 mg/kg, inj. Fentanyl 2 mcg/kg, inj. Propofol in titrated dosages till loss of consciousness and inj. Rocuronium 0.6 mg/kg to facilitate intubation. The time of induction will be noted. After intubation and securing airway, foley's catheterization of bladder will be done and patient will be positioned in prone position for surgery in which caudal epidural injection will also be given. After painting and draping, ultrasound guided visualization of sacral hiatus will be done. In longitudinal view, using in plane technique, 22 gauge Quincke's spinal needle will be inserted below sacrococcygeal ligament. After negative aspiration of blood and CSF, epidural space will also be confirmed by injecting 3 ml of normal saline. The prepared study drugs will be injected. The time of caudal drug administration will be noted. The surgical incision will be allowed after 20 minutes of injecting drugs in both groups, to allow fixation of drugs. The time of surgical incision will be noted. Anaesthesia will be maintained on oxygen, isoflurane and intermittent boluses of muscle relaxants. Inj. Paracetamol 1 g and inj. Diclofenac 75 mg will be given intravenously, around 1 hour before anticipated completion of surgery. Neuromuscular blockade will be reversed with inj. Neostigmine 0.05 mg/kg and inj. Glycopyrrolate 0.01 mg/kg. Patients will be extubated after return of consciousness and muscle power, and will be shifted to post-operative ward. VAS score will be recorded at immediate postoperative period, 4, 8, 12 and 24 hours. All patients will be given inj. Paracetamol 1 g 8 hourly and inj. Diclofenac 75 mg 12 hourly as an intravenous infusion. If any patients have VAS ≥ 4 at any time, rescue analgesia in form of inj. Pethidine 50 mg with inj. Promethazine 25 mg will be given intramuscularly. The time to demand of first dose of supplemental (rescue) analgesic medication will be recorded. Any complications and adverse drug reactions will be recorded.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients undergoing lumbosacral spine surgeries by posterior approach, including discectomy, laminectomy and laminotomy with or without instrumentation

2. ASA PS I and II

3. Age 18 to 65 years

Exclusion Criteria:

1. Patients with hypersensitivity to ropivacaine.

2. Patients with anomalies of sacral anatomy.

3. Local site infection

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• caudal epidural injection
Preoperative Ultrasound guided caudal epidural injection in lumbosacral spine surgeries for postoperative analgesia.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Trauma Center

References & Publications (17)

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Kalappa S, Sridhar RB, Nagappa S. Comparing the Efficacy of Caudal with Intravenous Dexamethasone in the Management of Pain Following Lumbosacral Spine Surgeries: A Randomized Double Blinded Controlled Study. Anesth Essays Res. 2017 Apr-Jun;11(2):416-420. doi: 10.4103/0259-1162.194581. — View Citation

Kalappa S, Sridhara RB, Kumaraswamy S. Dexmedetomidine as an Adjuvant to Pre-Emptive Caudal Epidural Ropivacaine for Lumbosacral Spine Surgeries. J Clin Diagn Res. 2016 Jan;10(1):UC22-4. doi: 10.7860/JCDR/2016/15286.7145. Epub 2016 Jan 1. — View Citation

Kao SC, Lin CS. Caudal Epidural Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:9217145. doi: 10.1155/2017/9217145. Epub 2017 Feb 26. — View Citation

Kiribayashi M, Inagaki Y, Nishimura Y, Yamasaki K, Takahashi S, Ueda K. Caudal blockade shortens the time to walking exercise in elderly patients following low back surgery. J Anesth. 2010 Apr;24(2):192-6. doi: 10.1007/s00540-009-0840-6. Epub 2010 Jan 19. — View Citation

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Kumar S, Palaniappan JM, Kishan A. Preemptive Caudal Ropivacaine: An Effective Analgesic during Degenerative Lumbar Spine Surgery. Asian Spine J. 2017 Feb;11(1):113-119. doi: 10.4184/asj.2017.11.1.113. Epub 2017 Feb 17. — View Citation

Meng T, Zhong Z, Meng L. Impact of spinal anaesthesia vs. general anaesthesia on peri-operative outcome in lumbar spine surgery: a systematic review and meta-analysis of randomised, controlled trials. Anaesthesia. 2017 Mar;72(3):391-401. doi: 10.1111/anae.13702. Epub 2016 Oct 22. — View Citation

Nikooseresht M, Hashemi M, Mohajerani SA, Shahandeh F, Agah M. Ultrasound as a screening tool for performing caudal epidural injections. Iran J Radiol. 2014 May;11(2):e13262. doi: 10.5812/iranjradiol.13262. Epub 2014 May 15. — View Citation

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Samagh N, Pai RK, Mathews TK, Jangra K, Varma RG. Pre-emptive caudal epidural analgesia with ropivacaine for lumbosacral spine surgery: A randomized case control study. J Anaesthesiol Clin Pharmacol. 2018 Apr-Jun;34(2):237-241. doi: 10.4103/joacp.JOACP_72_17. — View Citation

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Yoon JS, Sim KH, Kim SJ, Kim WS, Koh SB, Kim BJ. The feasibility of color Doppler ultrasonography for caudal epidural steroid injection. Pain. 2005 Nov;118(1-2):210-4. doi: 10.1016/j.pain.2005.08.014. Epub 2005 Oct 4. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale score	postoperative Visual Analogue Scale score	At immediate postoperative period
Primary	Visual Analogue Scale score	postoperative Visual Analogue Scale score	At 4 hours postoperatively
Primary	Visual Analogue Scale score	postoperative Visual Analogue Scale score	At 8 hours postoperatively
Primary	Visual Analogue Scale score	postoperative Visual Analogue Scale score	At 12 hours postoperatively
Primary	Visual Analogue Scale score	postoperative Visual Analogue Scale score	At 24 hours postoperatively
Primary	Time of rescue analgesia	Time of VAS score >4 asking for rescue analgesia	24 hours