Comparison of Dexamethasone and Magnesium Sulfate as an addition to Ropivacaine for Transverse Abdominis Plane Block in elective Cesarean section delivery under Spinal anesthesia for Post-Operative pain relief in central referral hospital, Gangtok

Not yet recruiting

• Conditions: Pregnancy, childbirth and the puerperium,

• Registration Number: CTRI/2021/04/033211
• Lead Sponsor: Sikkim Manipal Institute Of Medical Sciences

Brief Summary

**StudyTitle:** Comparative evaluation of Dexamethasone and Magnesium Sulfate as an Adjuvant to Ropivacaine for Transverse Abdominis Plane Block in Elective Cesarean section delivery for Post-Operative Analgesia in central referral hospital, Gangtok: A Triple blind randomised controlled trial

**Rationale:**Pain is ranked highest among undesirable clinical outcome associated with Lower segment cesarean section. Transverse abdominis plane (TAP) block a relatively a new peripheral nerve block technique provides effective post operative analgesia in lower abdominal surgery such as lower segment cesarean section. Drug such as ropivacaine a local anesthetic is gaining popularity because of its less cardiotoxic and neurotoxic potential. However the analgesic duration of local anesthetic is limited. Hence to prolong the duration of analgesia various adjuvants are added.  Dexamethasone and magnesium sulfate may be added to prolong the duration of analgesia.  There is only one study comparing the analgesic efficacy of above two adjuvants when added to ropivacaine. No placebo comparison was done in the previous study . So this study will be done to compare the duration of analgesia provided by ropivacaine alone, ropivacaine with dexamethasone and ropivacaine with magnesium sulfate through ultrasound guided transverse abdominis plane block in patients undergoing elective lower segment cesarean section under spinal anesthesia.

 

**Aim:** To evaluate the post-operative analgesic efficacy of two different adjuvants when added to local anesthetic in an ultrasound-guided transversus abdominis plane block in patients undergoing lower segment cesarean section under subarachnoid blockade.



**Primary Objective:**duration of analgesia which is the time to the first request for additional analgesics (TFA)

**Secondary Objectives:**

assess the post-operative pain quality by Visual analogue scale (VAS) score at rest and movement

2.      opioid consumption over 24 h after surgery

3.      patient satisfaction score

4.      post-operative nausea score

5.      side-effects, if any

**Setting:** The study will be conducted in department of Anesthesiology, Central referral Hospital, Sikkim Manipal Institute Of Medical Sciences, Gangtok, Sikkim

**Design of study:** Triple blind randomized controlled study.

**Duration of study:** 1st May 2021-1st May 2022

**Sample size:** 30 patients in each group (a total of 90 patients).

**Participants:**Parturients of 18-45 years of age belonging to ASA physical status I and II, undergoing elective lower segment cesarean section surgery under spinal anesthesia

·         Exclusion criteria:

1.     refusal  to give consent

2.      history of drug allergy or local anesthetic toxicity

3.      BMI >35kg/m2 and pregnancy weight <50kg (to limit maximum Ropivacaine dose to 3mg/kg)

4.      Contraindications to regional anesthesia (bleeding diathesis, infection at the site of block and peripheral neuropathy)

5.      pregnancy induced complications like pre-eclampsia, eclampsia, gestational diabetes

6.      intra-operative complications like post-partum hemorrhage

**Methods:** At the end of cesarean section, ultrasound guided transverse abdominis plane block will be done under all aseptic precautions along the mid axillary line. Drug will be given according to the group allotted as under:

Group I:    20 ml 0.375% ropivacaine + 2ml normal saline

Group II:  20 ml 0.375% ropivacaine + 1ml of 4mg dexamethasone+ 1ml normal saline

Group III: 20 ml 0.375% ropivacaine + 1.5 ml of 150 mg Mgso4 + 0.5 ml normal saline

Post operatively VAS score will be assessed at rest and movement, hemodynamic variables will also be recorded, total tramadol consumption , nausea score and patient satisfaction score will be recorded up-to 24 hours from the time of TAP block administered.

**Primary outcome:** duration of analgesia as defined by time from administration of drug through TAP Block  till patients complains of pain with

VAS≥ 4.

**Secondary outcome measures:**   assess the post-operative pain quality by Visual analogue scale (VAS) score at rest and movement, opioid consumption over 24 h after surgery, patient satisfaction score, post-operative nausea score, side-effects, if any

**Statistical Analysis:** All the analysis will be carried out in latest SPSS, software version. The quantitative parameters like age, height, weight, time to first analgesic request and total doses of tramadol which are measured at one time point will be compared using unpaired t-test. Qualitative data like ASA PS, VAS score, nausea score and patient satisfaction score will be analyzed using the Chi-square test or Fischer’s exact test whichever is applicable. Repeated measures ANOVA will be used to compare the hemodynamic variables. A p-value<0.05 will be considered significant.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-05
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

1.All parturient > 18 years undergoing lower segment caesarean section under spinal anesthesia 2.Parturient with ASA grade I and II.

Exclusion Criteria

1.refusal to give consent 2.history of drug allergy or local anesthetic toxicity 3.BMI >35kg/m2 and pregnancy weight <50kg (to limit maximum Ropivacaine dose to 3mg/kg) 4.Contraindications to regional anesthesia (bleeding diathesis, infection at the site of block and peripheral neuropathy) 5.pregnancy induced complications like pre-eclampsia, eclampsia, gestational diabetes 6.intra-operative complications like post-partum hemorrhage.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To find the duration of analgesia which is the time to the first request for additional analgesics (TFA)	Time duration starting from time of TAP BLOCK till patient complains of pain or VAS4

Secondary Outcome Measures

Name	Time	Method
1.assess the post-operative pain quality by Visual analogue scale (VAS) score at rest and movement	2.opioid consumption over 24 h after surgery

Trial Locations

Locations (1)

Central referral hospital, Sikkim Manipal Institute of Medical Sciences.; 🇮🇳 East, SIKKIM, India

Central referral hospital, Sikkim Manipal Institute of Medical Sciences.

🇮🇳East, SIKKIM, India

Dr Lhamo Dolma

Principal investigator

8860394768

lhadol30@gmail.com