Optimal Intrathecal Morphine Dose for Better Post Cesarean Section Analgesia (Analgesia)
Comparison of Postoperative Analgesia With Different Doses of Intrathecal Morphine With Hyperbaric Bupivacaine and Fentanyl in Cesarean Section Patients: A Randomized Controlled Trial
Central neuraxial blocks (CNBs) remain the preferred anesthetic technique for cesarean section, with single shot spinal anesthesia (SSSA) being the standard practice at investigator's institute unless contraindicated. SSSA offers reliable intraoperative anesthesia and provides a few hours of postoperative analgesia. Enhanced recovery after cesarean section protocol has recommended the addition of intrathecal (IT) morphine to improve the postoperative quality of the recovery profile. Fentanyl improves the quality of intraoperative analgesia, while morphine significantly prolongs the postoperative pain relief, often lasting up to 24 hours.
Routine uterine exteriorization, practiced in all cases at investigator's institute, often results in peritoneal stretching pain during surgery. This visceral pain is managed with 10 mcg intrathecal fentanyl added to hyperbaric bupivacaine. For postoperative pain management, the intrathecal morphine is recommended by many guidelines and studies. Intrathecal morphine dose typically ranges from 50 to 300 mcg. The dose of morphine exceeding 150 mcg are usually associated with prolongation of analgesia with higher incidence of side effects like nausea, vomiting and pruritus. In selected cases, investigator had administered morphine 100-150 mcg and the clinical experience has shown reduced postoperative analgesic requirements and favorable recovery profile, with minimal adverse effects.
Despite these promising experiences and extensive literature on IT morphine, their is still lack formal data on the efficacy and safety profile of IT morphine in cesarean section patient. This comparative study will help institute to find the optimum dose of IT morphine with better postoperative analgesia quality with low side effects profile. The finding could serve as a foundation to promote routine use of intrathecal morphine in cesarean section anesthesia at investigator's institute.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Bashu Dev Parajuli, MD Anaesthesiology
- 電話番号：00977+ 9851179038
- メール：bashuparajuli2012@gmail.com
研究連絡先のバックアップ
- 名前：Pooja Poudyal, MD Obstetric and Gynaecology
- 電話番号：00977+9841526853
- メール：paudyalpooja@yahoo.com
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Pregnant lady > 36 weeks of gestation presenting for cesarean section under spinal anesthesia
- ASA II/ III
- Maternal Height > 150 cm
- BMI< 40 Kg/m2
- Elective Indication
Exclusion Criteria:
- Patient unwilling to take part in the study
- Patient with known allergy to the study medications
- Contraindication to Spinal Anesthesia
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Group BF
Intrathecal drug used: 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml),
total volume of 2.2ml, single administration, no repetition of intervention In this group, no dose of morphine will be added.
|
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
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実験的：Group BF-M50
Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml)
plus morphine 50mcg (0.05ml) with total volume of 2.25ml single administration, no repetition of intervention
|
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 50mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
|
|
実験的：Group BF-M100
Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml)
plus morphine 100mcg (0.1ml) with total volume of 2.3ml single administration, no repetition of intervention
|
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 100mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
|
|
実験的：Group BF-M150
Intrathecal drug used : 0.5% hyperbaric bupivacaine 10mg(2ml) with fentanyl 10mcg(0.2ml)
plus morphine 150mcg (0.15ml) with total volume of 2.35ml single administration, no repetition of intervention
|
Spinal anesthesia with 0.5% bupivacaine heavy with fentanyl with morphine 150mcg at L3-L4 intervertebral space using Quincke's spinal needle in sitting position in patients undergoing cesarean section to study the dose with better analgesia profile and lower side effect profile.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To compare the incidence of postoperative pain after cesarean section with different doses of intrathecal morphine with bupivacaine among the four groups.
時間枠：NRS score is measured in recovery room for postoperative pain assessment. This time will be recorded as "time zero". Then in postoperative ward, NRS score is measured at 2 hours, 4 hours, 6 hours, 12 hours and 24 hours from 'time zero".
|
The parturient among study groups receiving different dose of intrathecal morphine with bupivacaine were compared for incidence of postoperative cesarean section pain.
The pain is assessed by using Numerical Pain Rating Scale(NRS) ,a 11-point, standardized tool (0-10) in which 0 means "no pain" and 10 means "the worst pain imaginable".
The number of parturient with NRS more than 3 will be compared for postoperative pain among the 4 groups.
|
NRS score is measured in recovery room for postoperative pain assessment. This time will be recorded as "time zero". Then in postoperative ward, NRS score is measured at 2 hours, 4 hours, 6 hours, 12 hours and 24 hours from 'time zero".
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To compare the first rescue analgesia demand time among the four groups
時間枠：Postoperative period after cesarean delivery till 24 hour
|
Rescue analgesia demand is defined as the first time after the cesarean section when the NRS score > 3, and analgesic will be needed.
The time period after cesarean section when first rescue analgesic is needed will be compared among the four group.
Inj.Ketorolac 30 mg iv will be supplemented first as rescue analgesic and recorded.
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Postoperative period after cesarean delivery till 24 hour
|
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To compare the total analgesic consumption in first 24 hours among the parturient of four group
時間枠：Postoperative total analgesia consumption for first 24 hour
|
Total analgesia consumption is defined as the total amount of paracetamol, ketorolac and tramadol received in the first 24 hours.
From the time of first dose of ketorolac, regular analgesia will be prescribed as inj.
ketorolac 30mg iv 8 hourly and inj.
paracetamol 1gm iv 6 hourly for 24 hour.
If the NRS score >3 at any point of time apart from the regular above medication, then Inj.
tramadol 50 mg iv SOS will be provided and recorded.
The number pf parturient with total analgesics consumption in 24 hour will be compared among the four groups.
|
Postoperative total analgesia consumption for first 24 hour
|
|
To compare the frequency of rescue analgesia demanded by parturient in first 24 hours among the groups
時間枠：Postoperative period for first 24 hour
|
Frequency of rescue analgesia demand is measured by number of time patient with NRS >3 who demand for iv ketorolac, paracetamol and tramadol despite providing regular analgesia (inj ketorolac 30mg iv 8 hourly and inj.paracetamol 1gm iv 6 hourly) for 24 hour.
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Postoperative period for first 24 hour
|
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To compare the incidence of side effects like nausea, vomiting, respiratory depression, level of sedation and pruritus in first 24 hours among the groups
時間枠：Postoperative period for first 24 hour
|
Number of parturient with treatment related side effects like nausea, vomiting, pruritus, respiratory depression and level of sedation are assessed and compared among the groups. Level of sedation is assessed by Pasero Opioid - Induced Sedation Scale (POSS) This score consist: of : S Sleepy, easy to arouse
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Postoperative period for first 24 hour
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Sultan P, Halpern SH, Pushpanathan E, Patel S, Carvalho B. The Effect of Intrathecal Morphine Dose on Outcomes After Elective Cesarean Delivery: A Meta-Analysis. Anesth Analg. 2016 Jul;123(1):154-64. doi: 10.1213/ANE.0000000000001255.
- Choudhury M. Neuraxial anaesthesia in parturient with cardiac disease. Indian J Anaesth. 2018 Sep;62(9):682-690. doi: 10.4103/ija.IJA_474_18.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRC/IOM/D-2026-339
- NHRC 772-2025 (その他の識別子：NHRC)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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