The efficacy and safety of palatine nerve block in reducing postoperative pain and recovery time in patients undergoing conventional tonsillectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The primary outcome will be the level of postoperative pain, assessed using Wong Baker Faces Pain Rating Scale at regular intervals over 24 hours post surgery.
Study Overview
Brief Summary
This study will evaluate the efficacy of palatine nerve block in patients undergoing tonsillectomy. Tonsillectomy is a common surgical procedure often associated with significant postoperative pain which can delay recovery, reduce patient satisfaction and lead to complications. The palatine nerve block, targeting the greater and lesser palatine nerves, provides effective pain relief while reducing the need for systemic analgesics, minimizing side effects such as sedation and nausea and prompting early oral intake in children.
The study will adopt a prospective, randomized controlled trial design. Participants will be randomized into two groups: one receiving the palatine nerve block alongside standard care and another receiving standard care alone. Pain scores using a validated visual analogue scale will be measured post operatively at 1 hour, 4 hours, 12 hours and 24 hours postoperatively.
Data collection will be conducted over a 6-month period, with interim analyses to ensure safety and validity. Ethical approval and informed consent will be secured prior to study initiation.
By the end of the study, we will determine whether the palatine nerve block offers a safe and superior pain control compared to standard care, providing valuable insights for optimizing perioperative pain management in tonsillectomy patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 5.00 Year(s) to 16.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children under 16 years of age undergoing tonsillectomy using the dissection and snare technique for chronic tonsillitis.
Exclusion Criteria
- •Other tonsillectomy technique Duration of surgery more than 2 hours All other indications for tonsillectomy other than chronic tonsillitis Children with craniofacial abnormalities Children with history of cleft palate repair or other palatoplasty procedures.
Outcomes
Primary Outcomes
The primary outcome will be the level of postoperative pain, assessed using Wong Baker Faces Pain Rating Scale at regular intervals over 24 hours post surgery.
Time Frame: Assessment at 1 hour,4 hours,12 hours and 24 hours after surgery
Secondary Outcomes
- Secondary outcomes will include the time to first analgesic requirement, total analgesic consumption within 24 hours, incidence of complications, & parental satisfaction scores(Assessment at 1 hour,4 hours,12 hours & 24 hours after surgery & 1 week after surgery)
Investigators
Shilpa Susan Mathew
Christian Medical College,Vellore