A study to compare two drugs, levobupivacaine, tramadol and their combination for postoperative pain relief in children

Phase 2/3

Completed

• Conditions: Children with inguinal hernia

• Registration Number: CTRI/2018/04/013101
• Lead Sponsor: Sawai Man Singh Medical College

Brief Summary

**Backgroundand Aims:**

Caudal block is a safeand simple method of pain relief in young children with the drawback of a shortduration of analgesia which can be overcome by adding various adjuvants to theinjected local anaesthetic. We compared the effects of caudal levobupivacaine,tramadol and a combination of both in paediatric patients undergoing inguinalherniotomy.

**Method:**

After permission fromthe hospital ethics committee, in this randomised double blinded interventionalstudy 78 children aged 1 to 7 years, planned for inguinal herniotomy wererandomly allocated to 3 groups. Group L was administered levobupivacaine 0.125%1ml/kg, Group T received tramadol 1.5 mg/kg in 0.9% NS and Group LT 1ml/kg of0.125% levobupivacaine with 1.5mg/kg tramadol caudally. Observations were madefor postoperative pain, rescue analgesic doses and any adverse effects for 12hours postoperatively. The quantitative data collected was analysed by ANOVAtest.

**Results:**

All the groups were comparable with regards toage, sex and duration of surgery. No motor block was observed in any of thepatients. The mean duration of analgesia in Group L was 321.46 + 84.76minutes and in Group T was 565.19 + 107.08 minutes. The requirement forrescue analgesia in tramadol group was significantly less as compared tolevobupivacaine group. In contrast, none of the patients in Group LT requiredadditional analgesia during the 12-hour study period. Sedation scores and adverseeffects were comparable among all groups.

 **Conclusion:**

Addition of tramadol to caudal levobupivacaine significantly increasedthe duration and effectiveness of postoperative analgesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-03
• Study Completion: 2014-07-11
• Last Update Posted: 2018-03-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Children beloning to American Society of Anaesthesioloists grade I & II planned for inguinal herniotomy surgeries.

Exclusion Criteria

Patients undergoing emergency procedures, parental refusal to participate and children having a bleeding disorder or vertebral defects.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	Duration of analgesia

Secondary Outcome Measures

Name	Time	Method
Duration of motor blockade, total number of rescue analgesic doses required and recording of any adverse effects in the form of respiratory depression (rate less than 10 per minute or requiring supplemental oxygen), bradycardia, nausea and vomiting	Time to reach modified bromage scale to zero.

Trial Locations

Locations (1)

Sawai Man Singh Medical College; 🇮🇳 Jaipur, RAJASTHAN, India

Sawai Man Singh Medical College

🇮🇳Jaipur, RAJASTHAN, India

Rajat Dadheech

Principal investigator

7597607231

rajatdadheech.rd@gmail.com