跳至主要内容
临床试验/CTRI/2022/04/041624
CTRI/2022/04/041624已完成不适用

To compare the opioid sparing effects Of combination Of dexamethasone , paracetamol and ketorolac(DexPak) VS paracetamol , ketorolac in patients undergoing total laparoscopic hysterectomy: a prospective double blind randomized controlled trial.

Parin Lalwani1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Total intravenous Patient controlled analgesia(PCA) fentanyl consumption in the first 24 hours postoperatively

研究概览

简要总结

In recent times total laparoscopic hysterectomy has emerged as a new treatment modality which is quickly replacing the open abdominal hysterectomy. It has many advantages over abdominal hysterectomy of less postoperative morbidity, shorter hospital stay, being minimally invasive and faster recovery[1,2] . Despite these advantages, TLH is often associated with unexpectedly high levels of pain, most commonly due to inadequate pain control . Pain after TLH can be due various manipulation like pneumoperitonium, stretching of intra abdominal cavity and dissection of pelvic organs, apart from the incisional pain[3]

Opioids are one of the most common drugs used to alleviate postoperative pain, but they are associated with an array of side effects like sedation, reduced cognition, delirium, respiratory depression , nausea, vomiting ,ileus and pruritus[4]. These side effects cause delay in discharge and increase total cost of treatment.

In order to decrease these side effects multimodal analgesia using primarily non-opioid analgesics with additive or synergistic effects to produce superior analgesia while decreasing opioid use and side effects is being used. The most common non-opioid drugs used in multimodal analgesia regimen are acetaminophen, non-selective NSAIDS, selective COX-2(cyclooxygenase) NSAIDS, steroids , GABA agonists[gabapentin and pregabalin][5,6,7].

In our study we have used a combination of 3 drugs, Paracetamol, Ketorolac and Dexamethasone for a multimodal analgesia regime.

Paracetamol is a drug that is invariable used in multimodal analgesia regimens. Many clinical trial for gynaecological surgeries have shown that paracetamol provides better analgesia compared to a placebo and reduces opioid consumption[8,9,10]

 Ketorolac tromethamine is an NSAIDS which can be used intravenously. It has both analgesic and anti-inflammatory properties and can be used in moderate to severe post operative pain. It primarily act through inhabitation of prostaglandin synthesis via the Cox(cyclooxygenase) pathway. Studies have revealed that Ketorolac reduces postoperative pain and has opioid sparing effects but is less effective as a sole analgesic in moderate to severe postoperative pain[11,12]. Hence it is used in combination with other analgesic in multimodal analgesia regimes.

Dexamethasone is a glucocorticoids with a well established analgesic and anti-emetic properties.

 Thus the hypothesis of our study is that addition of preemptive Dexamethasone  to paracetamol and ketorolac combination will decrease cumulative opioid consumption as compared to paracetamol and ketorolac in women undergoing elective total laparoscopic hysterectomy.

          REFERENCES

1.Kluivers KB, JOHNSON NP , Chein P, Vierhout ME, Bongers M, Mol BW. Comparison of laparoscopic and abdominal hysterectomy in terms of quality of life:a systemic review . Eur J Obset gynecol reprod biol. 2008;136:3-8.

2.         Thiel J , Gameril A. Outpatient total laparoscopic hysterectomy . Journal of  American association of  gynecologic laparoscopists.2003;10:481-3.

3.         Choi JB , Kang K ,  Song MK , Seok S ,  Kim YH . Pain characteristics after laparoscopic hysterectomy. International journal of medical sciences.2016;13(8): 562.

4.Bowdle TA. Adverse effects of opioid agonist and antagonist in anaesthesia . Drug safety. 1998;19:173-89.

  5. Lirk P ,  Thiry J ,  Bonnet M , Joshi G ,  Bonnet F . Pain management after laparoscopic hysterectomy ; systemic review of literature and PROSPECT recommendations. Reg Anesth Pain Med. 2019;44:425-436.

6.       Wardhan R ,  Chilly J . Recent advances in acute pain management:understanding the mechanisms of acute pain, the prescription of opioids, and role of multimodal pain therapy. 2017.

7 NelsonG , Altman AD , Nick A , Meyer LA ,  Ramirez PT . Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced recovery after surgery (ERAS) Society recommendations- part 2. Gynecologic oncology. 2016; 140: 323-332.

8.Urman R ,  Boing E,  Pham AT. Improved outcomes associated with use of intravenous paracetamol for management of acute post surgical pain in cesarean section and hysterectomies . J clin med .2018;10[6]:499-507.

  1. Herring BO ,  Maldonado AS , Hawkins C, Kearson M ,Camejo M. Impact of intravenous acetaminophen on reducing opoid use after hysterectomy. Pharmacotherapy. 2014;34:27S -33S.

10.Marchand G, Azadi A, Sainz K. Efficacy of acetaminophen in ERAS protocols for total  laparoscopic hysterectomy.2021.

11. Mather Le . Do pharmacodynamics of NSAIDS suggest a role in management of post operative pain? Drugs .1992;44:1-12.

12. Cepeda MS, Carr DB, Miranda N, Diaz A, Silva C, Morales O. Comparison of morphine , ketorolac and their combination for post operative pain relief . Anaesthesiology. 2005;103:1225-32.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • •Patients of ASA physical status I and II posted for elective total laparoscopic hysterectomy.

排除标准

  • •1.Patient refusal 2.Known allergy to the drugs 3.History of chronic analgesic or steroid consumption 4.History of gastric or duodenal ulcer 5.BMI >30 6.History of asthma 7.History of diabetes mellitus 8.History of endometriosis 9.Chronic alcoholism 10.Liver and/or kidney dysfunction 11.Limitations in understanding use of PCA pump 12.Duration of surgery >2 hrs / converted to open surger.

结局指标

主要结局

Total intravenous Patient controlled analgesia(PCA) fentanyl consumption in the first 24 hours postoperatively

时间窗: 24 hours postoperatively

次要结局

  • 1.Time for first analgesic requirement(24 hours postoperatively)
  • 2.Post operative pain scores at rest and during movement 0min 15min 30min 1,2,4,8,12 and 24 hours postoperatively
  • Post operative nausea and vomiting(0min, 15min, 30min , 1,2,4,8,12,24 hours)
  • Wound healing(7 days postoperatively)

研究者

发起方
Parin Lalwani
申办方类型
Other [self]

研究点 (1)

Loading locations...

相似试验