Effect of TAP Block on Time Required for First Analgesic Dose After Cesarean Cection Under Spinal Anesthesia
NCT ID: NCT04623632
Last Updated: 2022-12-23
Study Results
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Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2020-09-20
2021-03-20
Brief Summary
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This study will evaluate the analgesic efficacy of TAP block using Modified Surgeon Assisted Bilateral TAP block for post caesarean analgesia in a randomized controlled trial.
Detailed Description
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The administration of opioids, local blocks and other analgesic medication is instituted to decrease the duration and intensity of postoperative pain as a part of a multimodal analgesic regimen. The transversusabdominis plane (TAP) block is a regional analgesic technique which blocks T6-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries .
In postoperative analgesia, efficacy of TAP block is equivalent to morphine with the additional benefits of increasing duration of analgesia, reducing postoperative opioid usage, with satisfactory pain relief and few side effects.
The TAP block avoids the risk of neuraxial complications and opioid complications in all patients. TAP block the neural afferents of theanterior abdominal wall after spreading of the local anesthetic agent in the neurofascial plan between the internal oblique and transversusabdominis muscle.
TAP block has been underutilized in spite of having very low complication and high success rate using ultrasound technique This may be due to the lack of availability of ultrasound at most of the centers, lack of training in ultrasound guided block technique.
A new technique can be used in TAP block without the fear of complications in the blind landmark based approach.The advantage of this technique includes avoiding missing the second pop in obese and pregnant patients due to thinning of the internal obliqueaponeurosis, reposition of the needle by surgeon if one enters the peritoneal cavity accidentally. Also there are nil chances of visceral injury thus can be safely used by a beginner without any fear of complication. However, there might be a chance of needle stick injury to the surgeon's hand.
This study aims to evaluate effect of the Modified Surgeon Assisted Bilateral TAP block on time required for first analgesic dose after Cesarean Section under spinal anesthesia
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Bupivacaine
the landmark is at the level of umbilicus 8 to 10 cms from midline bilaterally. A tiny nick is made in the skin with a 18G sharp needle to obliterate the cushion effect. Then an 18 G Tuohy needle will be insert perpendicular to skin directing the needle slightly towards the ipsilateral anterior superior iliac spine just before the closure of peritoneum. After feeling 2 pops of external and internal oblique aponeurosis the drug will be injected after aspiration. The injectate syringes will be prepared under aseptic technique; syringes contained bupivacaine 0.25% 40 ml. Once the plane is reached the surgeon places his hand inside the abdominal cavity at the level of needle insertion to reconfirm needle placement. A bleb is palpated by the surgeon as the injection continues. The back flow of drug after injection is one of the signs that drug has been deposited in the TAP plane
Transversus abdominus plane block
transversus abdominus plane block using 40 ml of bupivacaine 0.25%
Placebo
the landmark is at the level of umbilicus 8 to 10 cms from midline bilaterally. A tiny nick is made in the skin with a 18G sharp needle to obliterate the cushion effect. Then an 18 G Tuohy needle will be insert perpendicular to skin directing the needle slightly towards the ipsilateral anterior superior iliac spine just before the closure of peritoneum. After feeling 2 pops of external and internal oblique aponeurosis the drug will be injected after aspiration. The injectate syringes will be prepared under aseptic technique syringes contained either normal saline 40 ml. Once the plane is reached the surgeon places his hand inside the abdominal cavity at the level of needle insertion to reconfirm needle placement. A bleb is palpated by the surgeon as the injection continues. The back flow of drug after injection is one of the signs that drug has been deposited in the TAP plane
Transversus abdominus plane placebo
injection of 40 ml of normal saline in the transversus abdominus plane
Interventions
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Transversus abdominus plane block
transversus abdominus plane block using 40 ml of bupivacaine 0.25%
Transversus abdominus plane placebo
injection of 40 ml of normal saline in the transversus abdominus plane
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Normal singleton pregnancy.
3. With a gestational age of completed 37 weeks or more.
4. Category ІV cesarean section
Exclusion Criteria
2. Obese patients with a BMI \>40.
3. ASA III or ASA IV risk groups
4. Patients with contraindications to spinal anesthesia or history of allergy to bupivacaine.
5. patients who received analgesics in the past 24 hours
6. Infection in the region where the block would be performed.
7. Category І- Ц- Ш cesarean section
8. Refusal to participate in the study
18 Years
40 Years
FEMALE
No
Sponsors
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Ain Shams Maternity Hospital
OTHER
Responsible Party
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Ahmed Mohammed Elmaraghy
Lecturer of obstetrics and gynecology - faculty of medicine - Ainshams university
Principal Investigators
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Adel Shafik, MD
Role: STUDY_DIRECTOR
AinShams university
Locations
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AinShams university maternity hospital
Cairo, , Egypt
Countries
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References
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1. Ahmad M, Furqan A, Adnan M, Waris S and Yousuf M (2019):
Canakci E, Gultekin A, Cebeci Z, Hanedan B, Kilinc A. The Analgesic Efficacy of Transverse Abdominis Plane Block versus Epidural Block after Caesarean Delivery: Which One Is Effective? TAP Block? Epidural Block? Pain Res Manag. 2018 Oct 17;2018:3562701. doi: 10.1155/2018/3562701. eCollection 2018.
Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
McMorrow RC, Ni Mhuircheartaigh RJ, Ahmed KA, Aslani A, Ng SC, Conrick-Martin I, Dowling JJ, Gaffney A, Loughrey JP, McCaul CL. Comparison of transversus abdominis plane block vs spinal morphine for pain relief after Caesarean section. Br J Anaesth. 2011 May;106(5):706-12. doi: 10.1093/bja/aer061.
Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
6. Roy R and Pattnaik S (2016):
7. Sriramka B, Sahoo N and Panigrahi S (2012):
Other Identifiers
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3
Identifier Type: -
Identifier Source: org_study_id