A study to compare the pain relief by two modalities pudendal and caudal block in children undergoing genital surgeries.
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/11/060126
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research
- Brief Summary
Children undergo a variety of ambulatory urological surgeries, the commonest pathology being hypospadias. Similarly, chordee correction (orthoplasty), urethrocutaneous fistula closure, or genitoplasty are other common procedures done in children. All these procedures are associated with significant pain and require effective analgesia for better post-operative recovery.
Caudal epidural block is the commonest modality used for pain relief during intra and post-operative periods, by decreasing the release of stress hormones. However, the presence of anatomic variations, spine abnormalities, or in older children wherein the ligamentum flavum gets calcified makes the placement of the caudal epidural difficult. Also, there is a potential risk of rare complications like block failure (1.9%), infection, epidural hematoma, intravascular injection, intrathecal injection, motor blockade, and urinary retention, as depicted by the Pediatric regional anesthesia network. In the past there have been reports suggesting an association of caudal block (CB) to urethrocutaneous fistula, strictures, and wound dehiscence following hypospadias surgery.
Recently there is a trend towards using peripheral nerve blocks for pediatric urological procedures; the pudendal nerve block (PNB) is one of those, used for effective pain relief. Pudendal nerve supplies the perineum with somatosensory input for the penile region and arises from anterior rami of sacral segments (S2-4), it is a field block, wherein the local anesthetic is deposited adjacent to the terminal branches (perineal and dorsal penile nerve) and provides effective analgesia. It has been traditionally used for male genitalia surgeries, vaginal deliveries, chronic pain management, and hemorrhoidectomies.Although used for pain management in pediatric urological procedures, still there is limited data on its effectiveness, which warrants more randomized studies. It has been shown to reduce post-operative pain scores, decrease post-operative stay, and provide better parental satisfaction. Pudendal nerve block can be done by various approaches such as transgluteal, transrectal, and transvaginal either through Alcock’s canal or by interligamentous plane.With the advent of ultrasound, inherent risks with an inadvertent vascular or rectal injury can be mitigated, adding to the safety profile of pudendal nerve block with more consistent analgesic coverage.
We hypothesize that ultrasound(US)-guided PNB is not inferior to CB in terms of the Face Legs Activity Cry Consolability behavioral scale(FLACC) score at the 6th postoperative hour (with a non-inferiority margin (NIM) of 2), in children presenting for penile procedures under General Anesthesia.
The research question for this study is to determine the meaningful postoperative pain relief in children aged between 2 yrs. to 7 yrs. presenting for penile surgeries under general anesthesia and comparing the US-guided PNB with a caudal block by comparing the FLACC pain score at the 6th postoperative hour (noninferiority of the pudendal block with a margin of difference of 2) to be conducted in the elective operation theatre in the advanced pediatric centre, PGIMER Chandigarh.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Male
- Target Recruitment
- 70
1.Age 2-7 years 2.ASA 1 and 2 patients 3.Undergoing penile surgeries( urethroplasty, chordee correction, and correction of urethrocutaneous fistula) under general anesthesia.
1.Presence of a congenital heart disease 2.Presence of respiratory, renal, or hepatic dysfunction 3.ASA III and IV 4.Local infection 5.Coagulopathy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare Between-group differences in the FLACC pain scores 6 hour
- Secondary Outcome Measures
Name Time Method Intraoperative and postoperative opioid consumption 0, 30min, 60min, 120min, 6, 10, 12,18,24 hrs Postoperative Pain Assessment (FLACC Scale) 0, 30min, 60min, 120min, 6, 10, 12,18,24 hrs Duration of post-anesthesia care unit stay Up to 24 hours post-surgery Total analgesic consumption (acetaminophen/ketorolac) at 24 hours Time to first rescue analgesia Up to 24 hours post-surgery Complications of the block – hematoma, infection, Bradycardia, Hypotension, nausea, vomiting, block failure, duration of motor blockade. Up to 24 hours post-surgery
Trial Locations
- Locations (1)
Post Graduate institute of medical education and research
🇮🇳Chandigarh, CHANDIGARH, India
Post Graduate institute of medical education and research🇮🇳Chandigarh, CHANDIGARH, IndiaDr Venkata V Naidu BongaralaPrincipal investigator8095995533b.naidu777@gmail.com