Comparison of postoperative pain in low pressure pneumoperitoneum with deep neuromuscular block versus standard pressure pneumoperitoneum among patients undergoing laparoscopic Intraperitoneal Onlay Mesh ( IPOM ) plus repair for midline ventral hernia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1.To asses and compare pain during the post operative period at 6 hours and 24 hours post-surgery in two groups A(low pressure pneumoperitoneum with deep neuromuscular blockade) and B (standard pressure pneumoperitoneum)
研究概览
简要总结
The study is a single-institution prospective, randomised controlled non-inferiority trial conducted at the Department of Surgical Disciplines, AIMS, New Delhi. Sixty patients with primary ventral hernia (European Heria Society classification - umbilical hernia W1 and W2, defect size less than or equal to 4 cm) will be included, randomised into two groups of 35 each. Group A will undergo laparoscopic IPOM plus repair with low-pressure pneumoperitoneum (8-10 mmHg) and deep neuromuscular blockade (NMB), while Group B will undergo standard-pressure pneumoperitoneum (12-14 mmg). Randomisation will follow a computer-generated permuted block sequence (blocks of 10), sealed in envelopes.
Patients will be blinded to the intervention, and pain scores
will be assessed postoperatively by blinded clinicians.
Standard pre-operative workup includes blood tests (LFT, CBC, RFT, CRP, ESR, ete.), informed consent, and adherence to institutional anaesthetic protocols. During surgery, mesh fixation and defect closure will be performed laparoscopically by a skilled surgeon using a standardised approach. Post-operatively, blood markers will be reevaluated at 24 hours, and pain will be assessed using a visual analogue scale at 6 and 24 hours. Postoperative analgesia will be standardised across both groups. Data on operative outcomes, including inflammatory markers, pain, and complications, will be collected and analysed to compare the efficacy of the two techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •35 kg/m? WHO definition.
- •( normal, overweight , grade 1 obesity and grade 2 obesity ).
- •primary ventral hernia.
- •umbilical type W1 and W2 according to European hernia society classification.
- •patient is able to follow instruction.
排除标准
- •a) Unable to give consent or patient refusal.
- •b) Prolonged surgery due to intraoperative complications such as unexpected bleeding and hollow viscous injury.
- •c) Conversion to open surgery d)Unfit for general anaesthesia e)Pregnancy.
- •f)Need for additional port besides standard three port for IPOM Plus.
结局指标
主要结局
1.To asses and compare pain during the post operative period at 6 hours and 24 hours post-surgery in two groups A(low pressure pneumoperitoneum with deep neuromuscular blockade) and B (standard pressure pneumoperitoneum)
时间窗: Post operative period at 6 hours and 24 hours
次要结局
- 1.Compare difficulty in performing surgery according to predefined surgical rating scale - likert scale in group A & B(Immediately at the end of surgery)
- 2.Compare operative time( Skin incision to skin closure in minutes) in group A & B(Immediately at the end of surgery)
- 3. Compare rise of inflammatory markers post operatively – CRP in group A & B(24 hours post operatively)
- 4.Proportion of patients in which conversion to standard pressure pneumoperitoneum is required(At the end of data collection i.e. 1 year 6months)
- 5.Compare need for conversion of intracoporeal to transfacial method, for closure of defect in group A & B(Immediately at the end of surgery)
- 6.Compare need for additional analgesia( other than Paracetamol 10-15 mg/kg & diclofenac 1.5-2 mg/kg 1.5-2 mg/kg) in group A & B(6hors & 24 hours post operatively)
研究者
Aryan Gupta
Department of Surgical Disciplines, All India Institute Of Medical Sciences Delhi,