Dexamethasone, Paracetamol and Ketorolac combination for pain relief and opioid sparing effects in total laparoscopic hysterectomy
- Conditions
- Noninflammatory disorder of uterus, unspecified,
- Registration Number
- CTRI/2022/04/041624
- Lead Sponsor
- Parin Lalwani
- Brief Summary
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.
9. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 100
Patients of ASA physical status I and II posted for elective total laparoscopic hysterectomy.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total intravenous Patient controlled analgesia(PCA) fentanyl consumption in the first 24 hours postoperatively 24 hours postoperatively
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
All India Institute of Medical sciences
🇮🇳South, DELHI, India
All India Institute of Medical sciences🇮🇳South, DELHI, IndiaParin LalwaniPrincipal investigator9650533388drparinlalwani@gmail.com