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临床试验/NCT05856682
NCT05856682Enrolling By Invitation不适用

Pre-incision Versus Lapaorscopic-assisted Transversus Abdominis Plane (TAP) and Rectus Sheath Block for Post-Cholecystectomy Pain Management: A Randomized Controlled Trial

Patel Hospital, Pakistan2 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
224
试验地点
2
主要终点
Post-operative pain changes

研究概览

简要总结

The goal of this clinical trial is to compare pre-incision vs laparoscopic assisted Transversus abdominis plane and rectus sheath block in patients undergoing laparoscopic cholecystectomy. The main question it aims to answer is:

• if the effectiveness of TAP and rectus sheath block varies according to whether it is performed pre-incisional (pre emptive) or intraoperatively under Laparoscopic vision for laparoscopic cholecystectomies.

Participants will be assessed for pain at 3,6,12, and 24 hrs after surgery. Researchers will compare pain score between Laparoscopic-assisted TAP block(LATAP) and Rectus Sheath block vs Pre-incision TAP (PITAP ) .

详细描述

INTRODUCTION:

Every year Over 13 million Laparoscopic procedures are performed globally. In the USA, 90% of the cholecystectomies are performed with the laparoscopic technique

  • Laparoscopic cholecystectomy is the gold standard in many health centers as it is less invasive compared to open cholecystectomy.
  • Good post-operative pain control, not only prevents post-operative complications but is also essential for early ambulation and return to daily routine. It is important to keep side effects minimum besides pain relieve. Therefore pre-emptive wound analgesia has been popularized. Preemptive analgesia(for eg: TAP block) is defined as an anti-nociceptive treatment that is initiated before the surgical procedure in order to reduce the sensitization (occurs because of transmission of pain signals evoked by tissue damage) of the peripheral and central pain pathways. Some analyses have shown no beneficial effect(4) whereas some have failed to reach a final conclusion regarding efficacy of pre-emptive analgesia.
  • For post-laparoscopic pain management ,a multimodal approach with non-steroidal anti-inflammatory drugs, opioids and loco-regional techniques have been recommended . The Transversus Abdominis Plane (TAP) block is an analgesia technique that is loco-regional ,consists of infiltrating a local anesthetic solution between the plane of the Transversus abdominis muscle and the internal oblique muscle.
  • TAP block has gradually become an alternative postoperative analgesia technology and it was described in 2001 by Rafi. . Several techniques are currently used to deliver TAP blocks, including blinded double pop technique, ultrasound-guided and laparoscopic-assisted approaches. The latter was first described in 2011 by Chetwood et al. while performing laparoscopic nephrectomies . The advantages of this technique include ease of performance, less dependency on specialized skill set or equipment, time efficient, less risk of visceral injury and avoidance of intraperitoneal local anaesthetic infiltration .

RATIONALE: Many studies have demonstrated the therapeutic benefit of laparoscopic-assisted TAP block in initial post-operative pain management in comparision with periportal local anaesthetic infiltration for patients undergoing elective laparoscopic procedures(for eg; for laparoscopic hernia repair). To the best of our knowledge, there is a paucity of data since laparoscopic-assisted TAP block has not been utilized or evaluated prospectively to see if the effectiveness of TAP block varies according to whether it is performed pre-incisional (pre emptive) or intraoperatively under Laparoscopic vision for laparoscopic cholecystectomies. Moreover, the rectus sheath block in conjunction with TAP block has not been evaluated before.

OBJECTIVE :

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Double blinded study : participants and person assessing the post operative pain will be blinded to both the control and intervention group, person performing TAP block will not be assessing the outcome

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age above 18 to 75 years, both genders, Elective Laparoscopic Cholecystectomies, American Society of Anesthesiologists (ASA) physical status I & II, Give consent.

排除标准

  • o History of allergy , hypersentivity or contraindication to Rupivacaine, nalbuphine ,Paracetamol.
  • Local skin allergy
  • Laparoscopic converted to open
  • Previous open upper abdominal or midline surgeries
  • Diagnosis Of "Chronic Pain Syndrome"
  • Known Alcohol Or Substance Abuse Within The Last 6 Months
  • Anti-psychotic, antidepressants, steroids use
  • Multiple procedures planned under single GA
  • Pregnancy
  • Unable to understand i.e. deaf, language barrier, mentally incapacitated
  • Coagulopathy

结局指标

主要结局

Post-operative pain changes

时间窗: 3,6,12,24 hrs post-operatively

post operative chnage of pain score assessment at 3,6,12,24 hrs at resting and coughing. Pain score will be assessed using VAS score

次要结局

  • Visceral Injury(at the time of surgery)
  • Peritoneal injury(at the time of surgery)
  • Rescue analgesia need(Post operatively at 3,6,12,24hrs)
  • TAP and rectus sheath block timings(at the time of surgery)

研究者

发起方
Patel Hospital, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kanwal Nisa

Kanwal Nisa

Patel Hospital, Pakistan

研究点 (2)

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