Caudal Block Versus Dorsal Penile Nerve Block Plus Ring Block for Pain Management of Different Surgical Techniques of Circumcision in Infants and Children
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Duration of analgesia
研究概览
简要总结
Circumcision is one of the most commonly performed operations in the pediatric population and is a painful procedure. Circumcision is performed with two popular techniques, Plastibell and conventional dissection method (CDM). For intra-operative (OP) and post-OP pain relief, two commonly used local anesthetic techniques are caudal block (CB) and dorsal penile block (DPNB) plus ring block (RB) at the base of the penis. There are very few randomized controlled trials comparing these two methods of intra-OP and post-OP pain relief, for different surgical techniques and there is a lack of well-conducted studies comparing the quality of analgesia, need for rescue analgesia in the early post-OP period, complications, and parental satisfaction comparing these blocks. Furthermore, there is a lot of contradiction in the literature regarding the duration of analgesia produced with these techniques.
详细描述
Circumcision is one of the most commonly performed operations in the paediatric population and is a painful procedure. Circumcision is performed with two popular techniques, Plastibell and conventional dissection method. Two anesthetic techniques are commonly used for intra-operative (OP) and post-OP pain relief i.e CB and DPNB+RB at the base of the penis. Addition of dexmedetomidine to bupivacaine prolongs duration of analgesia of CB. Both anaesthesia techniques of pain relief have certain advantages and disadvantages and the superiority of any technique over the other has not been established.
There are very few randomized controlled trials comparing these two methods of intra-OP and post-OP pain relief, for different surgical techniques of circumcision and there is a lack of well-conducted studies comparing the quality of analgesia, need for rescue analgesia in the early post-OP period, complications, and parental satisfaction comparing these blocks. Furthermore, there is a lot of contradiction in the literature regarding the duration of analgesia produced with these techniques.
Poorly treated postoperative pain leads to fatigue and metabolic, endocrine, and immunological changes can lead to prolonged convalescence following surgery and is traumatic to the pediatric patients and their parents. In this study, the investigators planned to compare the two most popular methods of pain relief during and after circumcision, along with parents' satisfaction.
This research will guide the anesthetists regarding the selection of appropriate techniques of intra-OP and post-OP analgesia and in light of intra and post-OP data; and parents' satisfaction.
In this prospective randomized study the investigators plan to compare the quality of intra and post OP analgesia and the duration of post-OP analgesia produced by CB and DPNB +RB, need of rescue analgesia with both of the techniques of surgery, intra-OP hemodynamic variations, residual motor block, and adverse effects and parents' satisfaction with both of the anesthesia and the surgical techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 4 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ages 3 months to 4 years,
- •Scheduled for circumcision for various indications under GA.
排除标准
- •Patients with bleeding or clotting disorders
- •Patients with hypospadias, other penile or sacral anomalies
- •Patients weight <3kg.
- •Allergy to Local Anesthetic
- •Infection at the site of block
- •Pre-existing spinal or neurological disease
- •Pain medication within the previous 48 hours
研究组 & 干预措施
Caudal block and circumcision with Plastibell,
Caudal block will be performed with 0.75ml/kg of 0.25% bupivacaine containing 1 mic/kg dexmedetomidine. Circumcision will be done using plastibell. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.
干预措施: Caudal block (Drug)
Caudal block and circumcision with Plastibell,
Caudal block will be performed with 0.75ml/kg of 0.25% bupivacaine containing 1 mic/kg dexmedetomidine. Circumcision will be done using plastibell. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.
干预措施: Circumcision with Plastibell (Procedure)
Caudal block and circumcision with conventional dissection method
Caudal block will be performed with 0.75ml/kg of 0.25% bupivacaine containing 1 mic/kg dexmedetomidine. Circumcision will be done using the conventional dissection method. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.
干预措施: Caudal block (Drug)
Caudal block and circumcision with conventional dissection method
Caudal block will be performed with 0.75ml/kg of 0.25% bupivacaine containing 1 mic/kg dexmedetomidine. Circumcision will be done using the conventional dissection method. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.
干预措施: Conventional Dissection Method (Procedure)
Dorsal penile nerve block plus ring block and circumcision with Plastibell
Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using plastibell.
干预措施: Dorsal penile nerve block plus ring block (Drug)
Dorsal penile nerve block plus ring block and circumcision with Plastibell
Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using plastibell.
干预措施: Circumcision with Plastibell (Procedure)
Dorsal penile nerve block plus ring block and circumcision with conventional dissection method
Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using the conventional dissection method
干预措施: Dorsal penile nerve block plus ring block (Drug)
Dorsal penile nerve block plus ring block and circumcision with conventional dissection method
Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using the conventional dissection method
干预措施: Conventional Dissection Method (Procedure)
结局指标
主要结局
Duration of analgesia
时间窗: First 12 hours after surgery/intervention (circumcision)
To compare the duration of post-OP analgesia produced by CB and DPNB plus RB in children undergoing circumcision with two different surgical techniques.
Efficacy of analgesia using FLACC Scale
时间窗: First 12 hours after surgery/intervention (circumcision)
Postoperatively in the PACU, the child will be observed in the recovery room by a senior nurse blinded to the anesthetic technique and the FLACC score will be used for pain assessment (copy attached). The FLACC scale is a uni-dimensional behavioral pain assessment instrument to measure pain in young children in the post-OP period. It includes five items (Face, Leg, Activity, Cry, and Consolability) and has good inter-rater reliability (Kappa 0.52-0.82), as well as good content and convergent validity. The scale is scored in a range of 0-10 with 0 = no pain and 10 = severe pain. The FLACC is reliable in critically ill young children. The severity of pain will be classified using the total score 0=no pain, and 10= severe pain. I.V fentanyl will be administered in the dose of 0.5 mic/kg if the pain score is \>5 and the dose will be repeated if the FLACC score persisted \>5 after five minutes.
次要结局
- Time to discharge from PACU(First 12 hours after surgery (circumcision))
- Number of participants that needed rescue analgesia(first 12 hours after surgery (circumcision))
- Motor block score(first 12 hours after surgery (circumcision))
- Number of patients with infection(First 5 days after surgery (circumcision))
- Number of patients experiencing urinary retention(First 12 hours after surgery (circumcision))
- Blood pressure (mm/Hg)(during the surgery (from start time to end time of circumcision))
- Heart rate (beats/min)(during the surgery (from start time to end time of circumcision))
- Number of Participants with sedation(First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward)
- Number of Participants with nausea(First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward)
- Number of Participants with vomiting(First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward)
- Number of Participants with penile hematoma(First 12 hours after surgery/intervention: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward)
- Number of Participants with agitation(First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward)
- Total paracetamol doses administered(first 5 days after surgery (circumcision))
研究者
Mansoor Aqil
Professor
King Saud University