A Randomized controlled study to assess the efficacy of ropivacaine instillation through subgaleal drain for postcraniotomy pain
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- To Assess postoperative pain by NRS (Numeric Rating Scale)
Study Overview
Brief Summary
Title of this study isA randomized controlled study to assess the efficacy of ropivacaine instillation through subgaleal drain for postcraniotomy pain.
Majority of patients experiences moderate-to-severe pain after craniotomy.Wound instillation of local anaesthetic drugs as a modality for postoperative pain management has proved quite useful in surgeries such as spine surgeries, laparoscopy, mastectomy, hysterectomy and caesarean section. Various local anaesthetic (LA) drugs such as bupivacaine, levobupivacaine and ropivacaine have been studied for this technique. Ropivacaine is long- acting and exhibits differential blockade predominantly on sensory nerve fibres. It has been successfully and safely used in neurosurgical patients for local infiltration at pin sites, incision site and scalp block. Ropivacaine has better safety profile among all these drugs and had been studied its instillation via subgaleal drains in 0.25% concentration. As there is no study comparing the effect of low concentration of ropivacaine instillation through subgaleal drain so we planned to study the efficacy of low concentrations of ropivacaine such as 0.1% and 0.2% through subgaleal drain for postcraniotomy pain.
Aim of this study is to assess the efficacy of ropivacaine instillation through subgaleal drain for post craniotomy pain in patients undergoing elective craniotomy.
Objectiveis to assess postoperative pain by NRS (Numeric Rating Scale) and to compare the duration of analgesia.
In this study we will instill the 12ml of 0.1 % and 0.2% ropivacaine through subgaleal drain in post craniotomy patients at the time of dural closure. The patient will be divided into three groups consists of group A (NS), group B (0.1% Ropivacaine), group C ( 0.2% ropivacaine) Then we will assess the patients for post craniotomy pain through NRS scale, patient satisfaction score.
Outcome measures of this study will assess the post operative pain in patients undergoing elective craniotomy by NRS scale,patient satisfaction score, hemodynamic parameters such as HR, SBP, DBP, MAP,SPO2, RR, Preoperative and postoperative GCS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •American society of anaesthesiologists (ASA) Physical Status Grade I and II
- •Elective Craniotomy.
Exclusion Criteria
- •Patient refusal
- •Previous Head trauma
- •History of craniotomy
- •Chronic headache (migraine and cluster headache)
- •Glasgow Coma scale (GCS) <13
- •Active psychiatric disorders
- •Allergy to study drugs
- •Chronic opioid/analgesic abuse
- •Chronic steroid use.
Outcomes
Primary Outcomes
To Assess postoperative pain by NRS (Numeric Rating Scale)
Time Frame: From 0 minute to 24 hours
Secondary Outcomes
- 1.To compare the duration of analgesia.(2.To compare the rescue analgesic requirement in 24 hours postoperatively.)
Investigators
Priyanka Bhardwaj
Uttar pradesh university of medical sciences Saifai, Etawah